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1. Islet Autoimmunity is Highly Prevalent and Associated With Diminished β-Cell Function in Patients With Type 2 Diabetes in the Grade Study.

Author: Brooks-Worrell, Barbara, Hampe, Christiane S, Hattery, Erica G, Palomino, Brenda, Zangeneh, Sahar Z, Utzschneider, Kristina, Kahn, Steven E, Larkin, Mary E, Johnson, Mary L, Mather, Kieren J, Younes, Naji, Rasouli, Neda, Desouza, Cyrus, Cohen, Robert M, Park, Jean Y, Florez, Hermes J, Valencia, Willy Marcos, Shojaie, Ali, Palmer, Jerry P, Balasubramanyam, Ashok, Crandall, Jill P, McKee, Melissa Diane, Brown-Friday, Janet, Xhori, Entila, Ballentine-Cargill, Keisha, Duran, Sally, Lukin, Jennifer, Beringher, Stephanie, Gonzalez de la Torre, Susana, Phillips, Lawrence, Burgess, Elizabeth, Olson, Darin, Rhee, Mary, Wilson, Peter, Raines, Tasha Stephanie, Costello, Julie, Gullett, Chona, Maher-Albertelli, Maxine, Morehead, Folayan, Mungara, Radhika, Person, Saranjit, Savoye, Louise, Sibymon, Mabil, Tanukonda, Sridhar, White, Carol Ann, Holloway, Leah, Adams, Cynthia, Ross, April, Gonzalez Hattery, Erica, Gaba, Ruchi, Montes, Graciela, Wright, Charlyne, Hollander, Priscilla, Roe, Erin, Uy, Analyn, Burt, Polly, Estrada, Lorie, Chionh, Kris, Ismail-Beigi, Faramarz, Falck-Ytter, Corinna, Sayyed Kassem, Laure, Sood, Ajay, Tiktin, Margaret, Cramer, Bethany, Iacoboni, Jacalyn, Kononets, Maria V, Kulow, Tanya, Newman, Cynthia, Stancil, Katherine A, Sanders, Cristina, Tucker, Lisa, Werner, Amanda, Krol, Adrienne, McPhee, Gloria, Patel, Christine, Colosimo, Linda, Goland, Robin, Pring, James, Kringas, Patricia, Tejada, Jessica, Hausheer, Camille, Schneier, Harvey, Gumpel, Kelly, Kirpitch, Amanda, Green, Jennifer B, AbouAssi, Hiba, Chatterjee, Ranee, Feinglos, Mark N, English Jones, Jennifer, Khan, Shubi A, Kimpel, Jeanne B, Zimmer, Ronna P, Furst, Mary, Satterwhite, Barbara M, Thacker, Connie, Evans Kreider, Kathryn, Lteif, Amale, and Hamilton, Tonya
Subjects: Biomedical and Clinical Sciences, Immunology, Autoimmune Disease, Clinical Research, Diabetes, 2.1 Biological and endogenous factors, Aetiology, Metabolic and endocrine, GRADE Beta-cell Ancillary Study Network, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences
Abstract: Islet autoimmunity may contribute to β-cell dysfunction in type 2 diabetes (T2D). Its prevalence and clinical significance have not been rigorously determined. In this ancillary study to the Glycemia Reduction Approaches in Diabetes-A Comparative Effectiveness (GRADE) Study, we investigated the prevalence of cellular and humoral islet autoimmunity in patients with T2D duration 4·0±3·0 y, HbA1c 7·5±0·5% on metformin alone. We measured T cell autoreactivity against islet proteins, islet autoantibodies against GAD65, IA2, ZnT8, and β-cell function. Cellular islet autoimmunity was present in 41·3%, humoral islet autoimmunity in 13·5%, and both in 5·3%. β-cell function calculated as iAUC-CG and ΔC-peptide(0- 30)/Δglucose(0-30) from an oral glucose tolerance test was lower among T cell-positives (T+) than T cell-negatives (T-) using two different adjustments for insulin sensitivity (iAUC-CG: 13·2% [95% CI 0·3, 24·4%] or 11·4% [95% CI 0·4, 21·2%] lower; ΔC-peptide(0-30)/Δglucose(0-30)) 19% [95% CI 3·1, 32·3%] or 17·7% [95% CI 2·6, 30·5%] lower). T+ patients had 17% higher HbA1c (95% CI 0·07, 0·28) and 7·7 mg/dL higher fasting plasma glucose levels (95% CI 0·2,15·3) than T- patients. We conclude that islet autoimmunity is much more prevalent in T2D patients than previously reported. T cell-mediated autoimmunity is associated with diminished β-cell function and worse glycemic control.
Published: 2022

2. Association of Glycemia, Lipids, and Blood Pressure With Cognitive Performance in People With Type 2 Diabetes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Author: Luchsinger, José A, Younes, Naji, Manly, Jennifer J, Barzilay, Joshua, Valencia, Willy, Larkin, Mary E, Falck-Ytter, Corinna, Krause-Steinrauf, Heidi, Pop-Busui, Rodica, Florez, Hermes, Seaquist, Elizabeth, Crandall, Jill P, McKee, Melissa Diane, Brown-Friday, Janet, Xhori, Entila, Ballentine-Cargill, Keisha, Duran, Sally, Lukin, Jennifer, Beringher, Stephanie, Gonzalez de la torre, Susana, Phillips, Lawrence, Burgess, Elizabeth, Olson, Darin, Rhee, Mary, Wilson, Peter, Raines, Tasha Stephanie, Costello, Julie, Gullett, Chona, Maher-Albertelli, Maxine, Morehead, Folayan, Mungara, Radhika, Person, Saranjit, Savoye, Louise, Sibymon, Mabil, Tanukonda, Sridhar, White, Carol Ann, Holloway, Leah, Adams, Cynthia, Ross, April, Balasubramanyam, Ashok, Gonzalez, Erica, Wright, Charlyne, Hollander, Priscilla, Roe, Erin, Uy, Analyn, Burt, Polly, Estrada, Lorie, Chionh, Kris, Ismail-Beigi, Faramarz, Sayyed Kassem, Laure, Sood, Ajay, Tiktin, Margaret, Cramer, Bethany, Iacoboni, Jacalyn, Kononets, Maria V, Kulow, Tanya, Newman, Cynthia, Stancil, Katherine A, Sanders, Cristina, Tucker, Lisa, Werner, Amanda, Krol, Adrienne, McPhee, Gloria, Patel, Christine, Colosimo, Linda, Goland, Robin, Pring, James, Kringas, Patricia, Tejada, Jessica, Hausheer, Camille, Schneier, Harvey, Gumpel, Kelly, Kirpitch, Amanda, Green, Jennifer B, AbouAssi, Hiba, Chatterjee, Ranee, Feinglos, Mark N, English Jones, Jennifer, Khan, Shubi A, Kimpel, Jeanne B, Zimmer, Ronna P, Furst, Mary, Satterwhite, Barbara M, Thacker, Connie R, Evans Kreider, Kathryn, Mather, Kieren J, Lteif, Amale, Hamilton, Tonya, Patel, Nick, Riera, Gabriela, Jackson, Marcia, Pirics, Vivian, Howard, Devin, Aguillar, Danielle, Hurt, Sloan, Bergenstal, Richard, Carlson, Anders, Martens, Thomas, and Johnson, Mary
Subjects: Biomedical and Clinical Sciences, Hypertension, Clinical Research, Clinical Trials and Supportive Activities, Diabetes, Cardiovascular, Behavioral and Social Science, Aged, Blood Pressure, Cognition, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Female, Humans, Lipids, Middle Aged, GRADE Research Group, GRADE Research Group Investigators:, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract: ObjectiveType 2 diabetes is a risk factor for cognitive impairment. We examined the relation of glycemia, lipids, blood pressure (BP), hypertension history, and statin use with cognition in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).Research design and methodsCross-sectional analyses from GRADE at baseline examined the association of glycemia (hemoglobin A1c [HbA1c]), LDL, systolic BP (SBP) and diastolic BP (DBP), hypertension history, and statin use with cognition assessed by the Spanish English Verbal Learning Test, letter and animal fluency tests, and Digit Symbol Substitution Test (DSST).ResultsAmong 5,047 GRADE participants, 5,018 (99.4%) completed cognitive assessments. Their mean age was 56.7 ± 10.0 years, and 36.4% were women. Mean diabetes duration was 4.0 ± 2.7 years. HbA1c was not related to cognition. Higher LDL was related to modestly worse DSST scores, whereas statin use was related to modestly better DSST scores. SBP between 120 and 139 mmHg and DBP between 80 and 89 mmHg were related to modestly better DSST scores. Hypertension history was not related to cognition.ConclusionsIn people with type 2 diabetes of a mean duration of
Published: 2021

3. Characterization of HIV Risk Behaviors and Clusters Using HIV-Transmission Cluster Engine Among a Cohort of Persons Living with HIV in Washington, DC

Author: Wilbourn, Brittany, Saafir-Callaway, Brittani, Jair, Kamwing, Wertheim, Joel O, Laeyendeker, Oliver, Jordan, Jeanne A, Kharfen, Michael, Castel, Amanda, D'Angelo, Lawrence, Rakhmanina, Natella, Serlin, Michael, Kumar, Princy, Bamdad, Aria, Bezabeh, Tsedenia, Reamer, Susan, Sapozhnikova, Alla, Temprosa, Marinella, Younes, Naji, Liu, Jinxi, Xiao, Kevin, Byrne, Morgan, Greenberg, Alan, Jaurretche, Maria, Levy, Matthew, Monroe, Anne, Peterson, James, Happ, Lindsey Powers, Jordan, Jeanne, Ma, Yan, Akselrod, Hana, Wilcox, Ronald, Rana, Sohail, Horberg, Michael, Fernandez, Ricardo, Hebou, Annick, Dieffenbach, Carl, Masur, Henry, Bordon, Jose, Teferi, Gebeyehu, Benator, Debra, Ruiz, Maria Elena, and Abbott, Stephen
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, HIV/AIDS, Infectious Diseases, Sexually Transmitted Infections, Prevention, Clinical Research, Behavioral and Social Science, 2.4 Surveillance and distribution, 2.2 Factors relating to the physical environment, Infection, Good Health and Well Being, District of Columbia, Epidemics, HIV Infections, Humans, Molecular Epidemiology, Risk-Taking, United States, HIV, molecular epidemiology, HIV clusters, HIV-TRACE, DC Cohort Executive Committee, Virology, Clinical sciences
Abstract: Molecular epidemiology (ME) is one tool used to end the HIV epidemic in the United States. We combined clinical and behavioral data with HIV sequence data to identify any overlap in clusters generated from different sequence datasets; to characterize HIV transmission clusters; and to identify correlates of clustering among people living with HIV (PLWH) in Washington, District of Columbia (DC). First, Sanger sequences from DC Cohort participants, a longitudinal HIV study, were combined with next-generation sequences (NGS) from participants in a ME substudy to identify clusters. Next, demographic and self-reported behavioral data from ME substudy participants were used to identify risks of secondary transmission. Finally, we combined NGS from ME substudy participants with Sanger sequences in the DC Molecular HIV Surveillance database to identify clusters. Cluster analyses used HIV-Transmission Cluster Engine to identify linked pairs of sequences (defined as distance ≤1.5%). Twenty-eight clusters of ≥3 sequences (size range: 3-12) representing 108 (3%) participants were identified. None of the five largest clusters (size range: 5-12) included newly diagnosed PLWH. Thirty-four percent of ME substudy participants (n = 213) reported condomless sex during their last sexual encounter and 14% reported a Syphilis diagnosis in the past year. Seven transmission clusters (size range: 2-19) were identified in the final analysis, each containing at least one ME substudy participant. Substudy participants in clusters from the third analysis were present in clusters from the first analysis. Combining HIV sequence, clinical and behavioral data provided insights into HIV transmission that may not be identified using traditional epidemiological methods alone. Specifically, the sexual risk behaviors and STI diagnoses reported in the substudy survey may not have been disclosed during Partner Services activities and the survey data complemented clinical data to fully characterize transmission clusters. These findings can be used to enhance local efforts to interrupt transmission and avert new infections.
Published: 2021

4. Cardiovascular Outcomes in GRADE (Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness Study)

Author: Green, Jennifer B., Everett, Brendan M., Ghosh, Alokananda, Younes, Naji, Krause-Steinrauf, Heidi, Barzilay, Joshua, Desouza, Cyrus, Inzucchi, Silvio E., Pokharel, Yashashwi, Schade, David, Scrymgeour, Alexandra, Tan, Meng H., Utzschneider, Kristina M., Mudaliar, Sunder, Crandall, J.P., McKee, M.D., Behringer-Massera, S., Brown-Friday, J., Xhori, E., Ballentine-Cargill, K., Duran, S., Estrella, H., Gonzalez de la Torre, S., Lukin, J., Phillips, L.S., Burgess, E., Olson, D., Rhee, M., Wilson, P., Raines, T.S., Boers, J., Costello, J., Maher-Albertelli, M., Mungara, R., Savoye, L., White, C.A., Gullett, C., Holloway, L., Morehead, F., Person, S., Sibymon, M., Tanukonda, S., Adams, C., Ross, A., Balasubramanyam, A., Gaba, R., Gonzalez Hattery, E., Ideozu, A., Jimenez, J., Montes, G., Wright, C., Hollander, P., Roe, E., Jackson, A., Smiley, A., Burt, P., Estrada, L., Chionh, K., Ismail-Beigi, F., Falck-Ytter, C., Sayyed Kassem, L., Sood, A., Tiktin, M., Kulow, T., Newman, C., Stancil, K.A., Cramer, B., Iacoboni, J., Kononets, M.V., Sanders, C., Tucker, L., Werner, A., Maxwell, A., McPhee, G., Patel, C., Colosimo, L., Krol, A., Goland, R., Pring, J., Alfano, L., Kringas, P., Hausheer, C., Tejada, J., Gumpel, K., Kirpitch, A., Schneier, H., AbouAssi, H., Chatterjee, R., Feinglos, M.N., English Jones, J., Khan, S.A., Kimpel, J.B., Zimmer, R.P., Furst, M., Satterwhite, B.M., Thacker, C.R., Evans Kreider, K., Mariash, C.N., Mather, K.J., Ismail, H.M., Lteif, A., Mullen, M., Hamilton, T., Patel, N., Riera, G., Jackson, M., Pirics, V., Aguillar, D., Howard, D., Hurt, S., Bergenstal, R., Carlson, A., Martens, T., Johnson, M., Hill, R., Hyatt, J., Jensen, C., Madden, M., Martin, D., Willis, H., Konerza, W., Yang, S., Kleeberger, K., Passi, R., Fortmann, S., Herson, M., Mularski, K., Glauber, H., Prihoda, J., Ash, B., Carlson, C., Ramey, P.A., Schield, E., Torgrimson-Ojerio, B., Arnold, K., Kauffman, B., Panos, E., Sahnow, S., Bays, K., Berame, K., Cook, J., Ghioni, D., Gluth, J., Schell, K., Criscola, J., Friason, C., Jones, S., Nazarov, S., Rassouli, N., Puttnam, R., Ojoawo, B., Nelson, R., Curtis, M., Hollis, B., Sanders-Jones, C., Stokes, K., El-Haqq, Z., Kolli, A., Tran, T., Wexler, D., Larkin, M.E., Meigs, J., Chambers, B., Dushkin, A., Rocchio, G., Yepes, M., Steiner, B., Dulin, H., Cayford, M., Chu, K., DeManbey, A., Hillard, M., Martin, K., Thangthaeng, N., Gurry, L., Kochis, R., Raymond, E., Ripley, V., Stevens, C., Park, J., Aroda, V., Ghazi, A., Magee, M., Ressing, A., Loveland, A., Hamm, M., Hurtado, M., Kuhn, A., Leger, J., Manandhar, L., Mwicigi, F., Sanchez, O., Young, T., Garg, R., Lagari-Libhaber, V., Florez, H.J., Valencia, W.M., Marks, J., Casula, S., Oropesa-Gonzalez, L., Hue, L., Cuadot, A., Nieto-Martinez, R., Riccio Veliz, A.K., Gutt, M., Kendal, Y.J., Veciana, B., Ahmann, A., Aby-Daniel, D., Joarder, F., Morimoto, V., Sprague, C., Yamashita, D., Cady, N., Rivera-Eschright, N., Kirchhoff, P., Morales Gomez, B., Adducci, J., Goncharova, A., Hox, S.H., Petrovitch, H., Matwichyna, M., Jenkins, V., Broadwater, L., Ishii, R.R., Bermudez, N.O., Hsia, D.S., Cefalu, W.T., Greenway, F.L., Waguespack, C., King, E., Fry, G., Dragg, A., Gildersleeve, B., Arceneaux, J., Haynes, N., Thomassie, A., Pavlionis, M., Bourgeois, B., Hazlett, C., Henry, R., Boeder, S., Pettus, J., Diaz, E., Garcia-Acosta, D., Maggs, S., DeLue, C., Stallings, A., Castro, E., Hernandez, S., Krakoff, J., Curtis, J.M., Killean, T., Khalid, M., Joshevama, E., Diaz, E., Martin, D., Tsingine, K., Karshner, T., Albu, J., Pi-Sunyer, F.X., Frances, S., Maggio, C., Ellis, E., Bastawrose, J., Gong, X., Banerji, M.A., August, P., Lee, M., Lorber, D., Brown, N.M., Josephson, D.H., Thomas, L.L., Tsovian, M., Cherian, A., Jacobson, M.H., Mishko, M.M., Kirkman, M.S., Buse, J.B., Diner, J., Dostou, J., Machineni, S., Young, L., Bergamo, K., Goley, A., Kerr, J., Largay, J.F., Guarda, S., Cuffee, J., Culmer, D., Fraser, R., Almeida, H., Coffer, S., Debnam, E., Kiker, L., Morton, S., Josey, K., Fuller, G., Garvey, W.T., Cherrington, A.L., Dyer, D., Lawson, M.C.R., Griffith, O., Agne, A., McCullars, S., Cohen, R.M., Craig, J., Rogge, M.C., Burton, K., Kersey, K., Wilson, C., Lipp, S., Vonder Meulen, M.B., Adkins, C., Onadeko, T., Rasouli, N., Baker, C., Schroeder, E., Razzaghi, M., Lyon, C., Penaloza, R., Underkofler, C., Lorch, R., Douglass, S., Steiner, S., Sivitz, W.I., Cline, E., Knosp, L.K., McConnell, J., Lowe, T., Herman, W.H., Pop-Busui, R., Martin, C., Waltje, A., Katona, A., Goodhall, L., Eggleston, R., Kuo, S., Bojescu, S., Bule, S., Kessler, N., LaSalle, E., Whitley, K., Seaquist, E.R., Bantle, A., Harindhanavudhi, T., Kumar, A., Redmon, B., Bantle, J., Coe, M., Mech, M., Taddese, A., Lesne, L., Smith, S., Kuechenmeister, L., Shivaswamy, V., Burbach, S., Rodriguez, M.G., Seipel, K., Alfred, A., Morales, A.L., Eggert, J., Lord, G., Taylor, W., Tillson, R., Adolphe, A., Burge, M., Duran-Valdez, E., Martinez, J., Bancroft, A., Kunkel, S., Ali Jamaleddin Ahmad, F., Hernandez McGinnis, D., Pucchetti, B., Scripsick, E., Zamorano, A., DeFronzo, R.A., Cersosimo, E., Abdul-Ghani, M., Triplitt, C., Juarez, D., Mullen, M., Garza, R.I., Verastiqui, H., Wright, K., Puckett, C., Raskin, P., Rhee, C., Abraham, S., Jordan, L.F., Sao, S., Morton, L., Smith, O., Osornio Walker, L., Schnurr-Breen, L., Ayala, R., Kreymer, R.B., Sturgess, D., Kahn, S.E., Alarcon-Casas Wright, L., Boyko, E.J., Tsai, E.C., Trence, D.L., Trikudanathan, S., Fattaleh, B.N., Montgomery, B.K., Atkinson, K.M., Kozedub, A., Concepcion, T., Moak, C., Prikhodko, N., Rhothisen, S., Elasy, T.A., Martin, S., Shackelford, L., Goidel, R., Hinkle, N., Lovell, C., Myers, J., Lipps Hogan, J., McGill, J.B., Salam, M., Schweiger, T., Kissel, S., Recklein, C., Clifton, M.J., Tamborlane, W., Camp, A., Gulanski, B., Pham, K., Alguard, M., Gatcomb, P., Lessard, K., Perez, M., Iannone, L., Magenheimer, E., Montosa, A., Cefalu, W.T., Fradkin, J., Burch, H.B., Bremer, A.A., Nathan, D.M., Lachin, J.M., Buse, J.B., Kahn, S.E., Larkin, M.E., Tiktin, M., Wexler, D., Burch, H.B., Bremer, A.A., Lachin, J.M., Bebu, I., Butera, N., Buys, C.J., Fagan, A., Gao, Y., Gramzinski, M.R., Hall, S.D., Kazemi, E., Legowski, E., Liu, H., Suratt, C., Tripputi, M., Arey, A., Backman, M., Bethepu, J., Lund, C., Mangat Dhaliwal, P., McGee, P., Mesimer, E., Ngo, L., Steffes, M., Seegmiller, J., Saenger, A., Arends, V., Gabrielson, D., Conner, T., Warren, S., Day, J., Huminik, J., Soliman, E.Z., Zhang, Z.M., Campbell, C., Hu, J., Keasler, L., Hensley, S., Li, Y., Herman, W.H., Kuo, S., Martin, C., Waltje, A., Mihalcea, R., Min, D.J., Perez-Rosas, V., Prosser, L., Resnicow, K., Ye, W., Shao, H., Zhang, P., Luchsinger, J., Sanchez, D., Assuras, S., Groessl, E., Sakha, F., Chong, H., Hillery, N., Abdouch, I., Bahtiyar, G., Brantley, P., Broyles, F.E., Canaris, G., Copeland, P., Craine, J.J., Fein, W.L., Gliwa, A., Hope, L., Lee, M.S., Meiners, R., Meiners, V., O’Neal, H., Park, J.E., Sacerdote, A., Sledge Jr, E., Soni, L., Steppel-Reznik, J., and Turchin, A.
Published: 2024
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5. Association of Baseline Characteristics With Insulin Sensitivity and β-Cell Function in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study Cohort.

Author: Rasouli, Neda, Younes, Naji, Utzschneider, Kristina M, Inzucchi, Silvio E, Balasubramanyam, Ashok, Cherrington, Andrea L, Ismail-Beigi, Faramarz, Cohen, Robert M, Olson, Darin E, DeFronzo, Ralph A, Herman, William H, Lachin, John M, Kahn, Steven E, Crandall, Jill P, McKee, Melissa Diane, Brown-Friday, Janet, Xhori, Entila, Ballentine-Cargill, Keisha, Duran, Sally, Lukin, Jennifer, Beringher, Stephanie, de la torre, Susana Gonzalez, Phillips, Lawrence, Burgess, Elizabeth, Olson, Darin, Rhee, Mary, Wilson, Peter, Raines, Tasha Stephanie, Costello, Julie, Gullett, Chona, Maher-Albertelli, Maxine, Morehead, Folayan, Mungara, Radhika, Person, Saranjit, Savoye, Louise, Sibymon, Mabil, Tanukonda, Sridhar, Ann White, Carol, Holloway, Leah, Adams, Cynthia, Ross, April, Gonzalez, Erica, Wright, Charlyne, Hollander, Priscilla, Roe, Erin, Uy, Analyn, Burt, Polly, Estrada, Lorie, Chionh, Kris, Falck-Ytter, Corinna, Kassem, Laure Sayyed, Sood, Ajay, Tiktin, Margaret, Cramer, Bethany, Iacoboni, Jacalyn, Kononets, Maria V, Kulow, Tanya, Newman, Cynthia, Stancil, Katherine A, Sanders, Cristina, Tucker, Lisa, Werner, Amanda, Krol, Adrienne, McPhee, Gloria, Patel, Christine, Colosimo, Linda, Goland, Robin, Pring, James, Kringas, Patricia, Tejada, Jessica, Hausheer, Camille, Schneier, Harvey, Gumpel, Kelly, Kirpitch, Amanda, Green, Jennifer B, AbouAssi, Hiba, Chatterjee, Ranee, Feinglos, Mark N, Jones, Jennifer English, Khan, Shubi A, Kimpel, Jeanne B, Zimmer, Ronna P, Furst, Mary, Satterwhite, Barbara M, Thacker, Connie R, Kreider, Kathryn Evans, Mather, Kieren J, Lteif, Amale, Hamilton, Tonya, Patel, Nick, Riera, Gabriela, Jackson, Marcia, Pirics, Vivian, Howard, Devin, Aguillar, Danielle, Hurt, Sloan, Bergenstal, Richard, and Carlson, Anders
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Prevention, Diabetes, Metabolic and endocrine, Blood Glucose, C-Peptide, Child, Child, Preschool, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Female, Humans, Infant, Insulin, Insulin Resistance, Male, GRADE Research Group, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract: ObjectiveWe investigated sex and racial differences in insulin sensitivity, β-cell function, and glycated hemoglobin (HbA1c) and the associations with selected phenotypic characteristics.Research design and methodsThis is a cross-sectional analysis of baseline data from 3,108 GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) participants. All had type 2 diabetes diagnosed
Published: 2021

6. Optimization of Metformin in the GRADE Cohort: Effect on Glycemia and Body Weight

Author: Sivitz, William I, Phillips, Lawrence S, Wexler, Deborah J, Fortmann, Stephen P, Camp, Anne W, Tiktin, Margaret, Perez, Magalys, Craig, Jacqueline, Hollander, Priscilla A, Cherrington, Andrea, Aroda, Vanita R, Tan, Meng Hee, Krakoff, Jonathan, Rasouli, Neda, Butera, Nicole M, Younes, Naji, Crandall, Jill P, Diane McKee, Melissa, Brown-Friday, Janet, Xhori, Entila, Ballentine-Cargill, Keisha, Duran, Sally, Lukin, Jennifer, Beringher, Stephanie, Gonzalez de la torre, Susana, Phillips, Lawrence, Burgess, Elizabeth, Olson, Darin, Rhee, Mary, Wilson, Peter, Stephanie Raines, Tasha, Costello, Julie, Gullett, Chona, Maher-Albertelli, Maxine, Morehead, Folayan, Mungara, Radhika, Person, Saranjit, Savoye, Louise, Sibymon, Mabil, Tanukonda, Sridhar, Ann White, Carol, Holloway, Leah, Adams, Cynthia, Ross, April, Balasubramanyam, Ashok, Gonzalez, Erica, Wright, Charlyne, Hollander, Priscilla, Roe, Erin, Uy, Analyn, Burt, Polly, Estrada, Lorie, Chionh, Kris, Ismail-Beigi, Faramarz, Falck-Ytter, Corinna, Sayyed Kassem, Laure, Sood, Ajay, Cramer, Bethany, Iacoboni, Jacalyn, Kononets, Maria V, Kulow, Tanya, Newman, Cynthia, Stancil, Katherine A, Sanders, Cristina, Tucker, Lisa, Werner, Amanda, Krol, Adrienne, McPhee, Gloria, Patel, Christine, Colosimo, Linda, Goland, Robin, Pring, James, Kringas, Patricia, Tejada, Jessica, Hausheer, Camille, Schneier, Harvey, Gumpel, Kelly, Kirpitch, Amanda, Green, Jennifer B, AbouAssi, Hiba, Chatterjee, Ranee, Feinglos, Mark N, English Jones, Jennifer, Khan, Shubi A, Kimpel, Jeanne B, Zimmer, Ronna P, Furst, Mary, Satterwhite, Barbara M, Thacker, Connie R, Evans Kreider, Kathryn, Mather, Kieren J, Lteif, Amale, Hamilton, Tonya, Patel, Nick, Riera, Gabriela, Jackson, Marcia, Pirics, Vivian, Howard, Devin, and Aguillar, Danielle
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Clinical Research, Diabetes, Nutrition, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adult, Aged, Blood Glucose, Body Weight, Calibration, Comparative Effectiveness Research, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Liraglutide, Male, Maximum Tolerated Dose, Metformin, Middle Aged, Sitagliptin Phosphate, Sulfonylurea Compounds, Weight Loss, GRADE Research Group, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract: ObjectiveWe evaluated the effect of optimizing metformin dosing on glycemia and body weight in type 2 diabetes.Research design and methodsThis was a prespecified analysis of 6,823 participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) taking metformin as the sole glucose-lowering drug who completed a 4- to 14-week (mean ± SD 7.9 ± 2.4) run-in in which metformin was adjusted to 2,000 mg/day or a maximally tolerated lower dose. Participants had type 2 diabetes for
Published: 2020

7. Relationship Between Average Glucose Levels and HbA1c Differs Across Racial Groups: A Substudy of the GRADE Randomized Trial.

Author: Nathan, David M., Herman, William H., Larkin, Mary E., Krause-Steinrauf, Heidi, Abou Assi, Hiba, Ahmann, Andrew J., Brown-Friday, Janet, Hsia, Daniel S., Harindhanavudhi, Tasma, Johnson, Mary, Arends, Valerie L., Butera, Nicole M., Rosin, Samuel P., Lachin, John M., Younes, Naji, Everett, B.M., Abdouch, I., Bahtiyar, G., Brantley, P., and Broyles, F.E.
Subjects: CONTINUOUS glucose monitoring, BLOOD sugar, GLUCOSE tolerance tests, DEMOGRAPHIC characteristics, GLUCOSE
Abstract: OBJECTIVE: To determine whether the relationship between average glucose (AG) levels and hemoglobin A1c (HbA1c) differs across racial/ethnic groups. RESEARCH DESIGN AND METHODS: We performed a prospective substudy of GRADE, a comparative effectiveness randomized trial conducted in 36 centers in the U.S. A total of 1,454 of the 5,047 participants in the GRADE cohort, including 534 non-Hispanic White (NHW), 389 non-Hispanic Black (NHB), and 327 Hispanic White patients and 204 patients of other racial/ethnic backgrounds, were included in the substudy. Continuous glucose monitoring (CGM) performed for 10 days was used to calculate AG10. Immediately after CGM, HbA1c and glycated albumin were measured. Fasting plasma glucose (FPG) and glucose area under the curve (AUC) were derived from a 75-g oral glucose tolerance test. RESULTS: The relationship between AG10 and HbA1c was significantly different for NHB compared with NHW patients and those of other racial/ethnic groups. HbA1c levels were 0.2–0.6 percentage points higher in NHB than in NHW patients for AG10 levels from 100 to 250 mg/dL. For an HbA1c of 7%, AG10 was 11 mg/dL higher for NHW than for NHB patients. Similar findings were observed across races for relationships of FPG and AUC with HbA1c and for glucose measurements with glycated albumin levels. Differences in the relationship between AG10 and HbA1c across racial groups remained after adjustments for any demographic or other differences between racial/ethnic subgroups. CONCLUSIONS: The relationship between several measures of glucose with HbA1c and glycated albumin consistently differed across races. These findings should be considered in setting treatment goals and diagnostic levels. [ABSTRACT FROM AUTHOR]
Published: 2024
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8. Glycemia reduction in type 2 diabetes—Hypoglycemia outcomes: A randomized clinical trial.

Author: Seaquist, Elizabeth R., Phillips, Lawrence S., Ghosh, Alokananda, Baker, Chelsea, Bergenstal, Richard M., Crandall, Jill P., Goland, Robin S., Gramzinski, Michaela R., Hox, Sophia H., Hsia, Daniel S., Johnson, Mary L., Lachin, John M., Raskin, Philip, Valencia, Willy M., Waltje, Andrea H., and Younes, Naji
Subjects: TYPE 2 diabetes, CLINICAL trials, HYPOGLYCEMIA, SITAGLIPTIN, GLYCOSYLATED hemoglobin
Abstract: Objective: Hypoglycemia is a major concern in type 2 diabetes (T2DM), but little is known about its likelihood compared across common therapies. We compared the likelihood of hypoglycemia among metformin-treated patients with T2DM randomized to the addition of one of 4 common therapies. Research design & methods: Randomized, controlled trial of 5,047 participants with T2DM of <10 years' duration, hemoglobin A1c (HbA1c) 6.8–8.5% (50.8–69.4 mmol/mol). Randomization to addition of glargine U100, glimepiride, liraglutide, or sitagliptin over 5.0 ± 1.3 (mean ± SD) years. HbA1c was measured quarterly; if a level >7.5% (>58.5 mmol/mol) was confirmed, rescue glargine and/or aspart insulin was added. We conducted a per-protocol analysis of 4,830, who attended at least one post-baseline visit and took at least one dose of assigned study medication. We assessed severe hypoglycemia events reported throughout the entire study. At quarterly visits, all participants were asked about hypoglycemic symptoms within the last 30 days, and those in the glargine and glimepiride groups were asked for any measured glucose <70 mg/dL (3.9 mmol/L) within this time period. Results: While participants were taking their assigned medications, severe hypoglycemia occurred in 10 (0.8%), 16 (1.3%), 6 (0.5%), and 4 (0.3%), (p<0.05) and hypoglycemic symptoms in 659 (54.2%), 833 (68.3%), 375 (32.4%), and 361 (29.1%) of participants following randomization to glargine, glimepiride, liraglutide, and sitagliptin, respectively (p<0.001). Conclusions: In metformin-treated patients with T2DM who add a second medication, hypoglycemia is most likely with addition of glimepiride, less with glargine, and least likely with liraglutide and sitagliptin. Trial registration: ClinicalTrials.gov Identifier: NCT01794143. [ABSTRACT FROM AUTHOR]
Published: 2024
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9. Association of glycemia with insulin sensitivity and β-cell function in adults with early type 2 diabetes on metformin alone

Author: Utzschneider, Kristina M., Younes, Naji, Rasouli, Neda, Barzilay, Joshua, Banerji, Mary Ann, Cohen, Robert M., Gonzalez, Erica V., Mather, Kieren J., Ismail-Beigi, Faramarz, Raskin, Philip, Wexler, Deborah J., Lachin, John M., and Kahn, Steven E.
Published: 2021
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10. The cross-sectional association of renal dysfunction with tests of cognition in middle-aged adults with early type 2 diabetes: The GRADE Study

Author: Barzilay, Joshua I., Younes, Naji, Pop-Busui, Rodica, Florez, Hermes, Seaquist, Elizabeth, Falck-Ytter, Corinna, and Luchsinger, Jose A.
Published: 2021
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11. Cholesterol-lowering effect of statin therapy in a clinical HIV cohort: an application of double propensity score adjustment

Author: Levy, Matthew E., Ma, Yan, Magnus, Manya, Younes, Naji, and Castel, Amanda D.
Published: 2020
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12. The incidence of retinopathy in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness study (GRADE)

Author: Hsia, Daniel S., primary, Younes, Naji, additional, Krause-Steinrauf, Heidi, additional, and Kassem, Laure Sayyed, additional
Published: 2024
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13. Incidence and Risk Factors for Renal Disease in an Outpatient Cohort of HIV-Infected Patients on Antiretroviral Therapy

Author: Subramanian, Thilakavathy, Binkley, Jeffery, Taylor, Rob, Rayeed, Nabil, Akridge, Cheryl, Purinton, Stacey, Naughton, Jeff, D'Angelo, Lawrence, Kharfen, Michael, Wood, Angela, Serlin, Michael, Kumar, Princy, Parenti, David, Castel, Amanda, Greenberg, Alan, Monroe, Anne, Happ, Lindsey Powers, Jaurretche, Maria, Lewis, Brittany, Peterson, James, Younes, Naji, Wilcox, Ronald, Rana, Sohail, Horberg, Michael, Fernandez, Ricardo, Hebou, Annick, Dieffenbach, Carl, Masur, Henry, Bordon, Jose, Teferi, Gebeyehu, Benator, Debra, Ruiz, Maria Elena, Goldstein, Deborah, Hardy, David, Doshi, Saumil, Ucanda, Martin, Hart, Rachel, Hou, Qingjiang, and Terzian, Arpi S.
Published: 2019
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14. Mortality in the Glycemia Reduction Approaches in Type 2 Diabetes (GRADE) Study: A Comparative Effectiveness Randomized Clinical Trial

Author: Ann Banerji, Mary, primary, B. Buse, John, primary, Younes, Naji, primary, Krause-Steinrauf, Heidi, primary, Ghazi, Adline, primary, Lee, Melissa, primary, Park, Jean, primary, Pop-Busui, Rodica, primary, Underkofler, Chantal, primary, and P. Fortmann, Stephen, primary
Published: 2024
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15. GAD65Abs Are Not Associated With Beta-Cell Dysfunction in Patients With T2D in the GRADE Study

Author: Hampe, Christiane S, primary, Shojaie, Ali, additional, Brooks-Worrell, Barbara, additional, Dibay, Sepideh, additional, Utzschneider, Kristina, additional, Kahn, Steven E, additional, Larkin, Mary E, additional, Johnson, Mary L, additional, Younes, Naji, additional, Rasouli, Neda, additional, Desouza, Cyrus, additional, Cohen, Robert M, additional, Park, Jean Y, additional, Florez, Hermes J, additional, Valencia, Willy Marcos, additional, Palmer, Jerry P, additional, and Balasubramanyam, Ashok, additional
Published: 2024
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16. Longitudinal effects of glucose-lowering medications on β-cell responses and insulin sensitivity in type 2 diabetes: The GRADE randomized clinical trial

Author: Rasouli, Neda, primary, Younes, Naji, primary, Ghosh, Alokananda, primary, Albu, Jeanine, primary, Cohen, Robert M., primary, DeFronzo, Ralph A., primary, Diaz, Elsa, primary, Sayyed Kassem, Laure, primary, Luchsinger, José A., primary, McGill, Janet B., primary, I. Sivitz, William, primary, Tamborlane, William V., primary, Utzschneider, Kristina M., primary, and Kahn, Steven E., primary
Published: 2024
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17. Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes (GRADE) Study: A Comparative Effectiveness Randomized Clinical Trial

Author: L. Cherrington, Andrea, primary, T. Tripputi, Mark, primary, Younes, Naji, primary, H. Herman, William, primary, Katona, Aimee, primary, J. Groessl, Erik, primary, Craig, Jacqueline, primary, S. Gonzalez, Jeffrey, primary, Garg, Rajesh, primary, Casula, Sabina, primary, Kuo, Shihchen, primary, and J. Florez, Hermes, primary
Published: 2024
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18. Impact of insulin sensitivity and β-cell function over time on glycemic outcomes in the GRADE (Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness) Study: differential treatment effects of dual therapy.

Author: M Utzschneider, Kristina, primary, Younes, Naji, primary, M Butera, Nicole, primary, Balasubramanyam, Ashok, primary, M Bergenstal, Richard, primary, Barzilay, Joshua, primary, DeSouza, Cyrus, primary, DeFronzo, Ralph A., primary, Elasy, Tom, primary, Krakoff, Jonathan, primary, E Kahn, Steven, primary, Rasouli, Neda, primary, Valencia, Willy M., primary, and I Sivitz, William, primary
Published: 2024
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19. Effects of low-frequency electrical stimulation of the anterior piriform cortex on kainate-induced seizures in rats

Author: Bayat, Arezou, Skopin, Mark D., Joshi, Sweta, Siddu, Mithilesh, Mukharesh, Loulwah, Jahan, Sahar, Tsuchiya, Komei, Connell, Phillip, Younes, Naji, and Koubeissi, Mohamad Z.
Published: 2017
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20. Trends in the Incidence of Fatal Prostate Cancer in the United States by Race

Author: Kelly, Scott P., Rosenberg, Philip S., Anderson, William F., Andreotti, Gabriella, Younes, Naji, Cleary, Sean D., and Cook, Michael B.
Published: 2017
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21. Longitudinal Effects of Glucose-Lowering Medications on β-Cell Responses and Insulin Sensitivity in Type 2 Diabetes: The GRADE Randomized Clinical Trial.

Author: Rasouli, Neda, Younes, Naji, Ghosh, Alokananda, Albu, Jeanine, Cohen, Robert M., DeFronzo, Ralph A., Diaz, Elsa, Sayyed Kassem, Laure, Luchsinger, José A., McGill, Janet B., Sivitz, William I., Tamborlane, William V., Utzschneider, Kristina M., Kahn, Steven E., Crandall, J.P., McKee, M.D., Behringer-Massera, S., Brown-Friday, J., Xhori, E., and Ballentine-Cargill, K.
Subjects: *GLUCOSE tolerance tests, *TYPE 2 diabetes, *INSULIN sensitivity, *DRUGS, *CLINICAL trials, *SITAGLIPTIN
Abstract: OBJECTIVE: To compare the long-term effects of glucose-lowering medications (insulin glargine U-100, glimepiride, liraglutide, and sitagliptin) when added to metformin on insulin sensitivity and β-cell function. RESEARCH DESIGN AND METHODS: In the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) cohort with type 2 diabetes (n = 4,801), HOMA2 was used to estimate insulin sensitivity (HOMA2-%S) and fasting β-cell function (HOMA2-%B) at baseline and 1, 3, and 5 years on treatment. Oral glucose tolerance test β-cell responses (C-peptide index [CPI] and total C-peptide response [incremental C-peptide/incremental glucose over 120 min]) were evaluated at the same time points. These responses adjusted for HOMA2-%S in regression analysis provided estimates of β-cell function. RESULTS: HOMA2-%S increased from baseline to year 1 with glargine and remained stable thereafter, while it did not change from baseline in the other treatment groups. HOMA2-%B and C-peptide responses were increased to variable degrees at year 1 in all groups but then declined progressively over time. At year 5, CPI was similar between liraglutide and sitagliptin, and higher for both than for glargine and glimepiride [0.80, 0.87, 0.74, and 0.64 (nmol/L)/(mg/dL) * 100, respectively; P < 0.001], while the total C-peptide response was greatest with liraglutide, followed in descending order by sitagliptin, glargine, and glimepiride [1.54, 1.25, 1.02, and 0.87 (nmol/L)/(mg/dL) * 100, respectively, P < 0.001]. After adjustment for HOMA2-%S to obtain an estimate of β-cell function, the nature of the change in β-cell responses reflected those in β-cell function. CONCLUSIONS: The differential long-term effects on insulin sensitivity and β-cell function of four different glucose-lowering medications when added to metformin highlight the importance of the loss of β-cell function in the progression of type 2 diabetes. [ABSTRACT FROM AUTHOR]
Published: 2024
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22. Impact of Insulin Sensitivity and β-Cell Function Over Time on Glycemic Outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE): Differential Treatment Effects of Dual Therapy.

Author: Utzschneider, Kristina M., Younes, Naji, Butera, Nicole M., Balasubramanyam, Ashok, Bergenstal, Richard M., Barzilay, Joshua, DeSouza, Cyrus, DeFronzo, Ralph A., Elasy, Tom, Krakoff, Jonathan, Kahn, Steven E., Rasouli, Neda, Valencia, Willy M., Sivitz, William I., Crandall, J.P., McKee, M.D., Behringer-Massera, S., Brown-Friday, J., Xhori, E., and Ballentine-Cargill, K.
Subjects: *INSULIN sensitivity, *TREATMENT effectiveness, *COMPARATIVE method, *GLUCOSE tolerance tests, *GLYCEMIC control
Abstract: OBJECTIVE: To compare the effects of insulin sensitivity and β-cell function over time on HbA1c and durability of glycemic control in response to dual therapy. RESEARCH DESIGN AND METHODS: GRADE participants were randomized to glimepiride (n = 1,254), liraglutide (n = 1,262), or sitagliptin (n = 1,268) added to baseline metformin and followed for mean ± SD 5.0 ± 1.3 years, with HbA1c assessed quarterly and oral glucose tolerance tests at baseline, 1, 3, and 5 years. We related time-varying insulin sensitivity (HOMA 2 of insulin sensitivity [HOMA2-%S]) and early (0–30 min) and total (0–120 min) C-peptide (CP) responses to changes in HbA1c and glycemic failure (primary outcome HbA1c ≥7% [53 mmol/mol] and secondary outcome HbA1c >7.5% [58 mmol/mol]) and examined differential treatment responses. RESULTS: Higher HOMA2-%S was associated with greater initial HbA1c lowering (3 months) but not subsequent HbA1c rise. Greater CP responses were associated with a greater initial treatment response and slower subsequent HbA1c rise. Higher HOMA2-%S and CP responses were each associated with lower risk of primary and secondary outcomes. These associations differed by treatment. In the sitagliptin group, HOMA2-%S and CP responses had greater impact on initial HbA1c reduction (test of heterogeneity, P = 0.009 HOMA2-%S, P = 0.018 early CP, P = 0.001 total CP) and risk of primary outcome (P = 0.005 HOMA2-%S, P = 0.11 early CP, P = 0.025 total CP) but lesser impact on HbA1c rise (P = 0.175 HOMA2-%S, P = 0.006 early CP, P < 0.001 total CP) in comparisons with the glimepiride and liraglutide groups. There were no differential treatment effects on secondary outcome. CONCLUSIONS: Insulin sensitivity and β-cell function affected treatment outcomes irrespective of drug assignment, with greater impact in the sitagliptin group on initial (short-term) HbA1c response in comparison with the glimepiride and liraglutide groups. [ABSTRACT FROM AUTHOR]
Published: 2024
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23. Association of Baseline Factors With Glycemic Outcomes in GRADE: A Comparative Effectiveness Randomized Clinical Trial.

Author: Garvey, W. Timothy, Cohen, Robert M., Butera, Nicole M., Kazemi, Erin J., Younes, Naji, Rosin, Samuel P., Suratt, Colleen E., Ahmann, Andrew, Hollander, Priscilla A., Krakoff, Jonathan, Martin, Catherine L., Seaquist, Elizabeth, Steffes, Michael W., Lachin, John M., Crandall, J.P., McKee, M.D., Behringer-Massera, S., Brown-Friday, J., Xhori, E., and Ballentine-Cargill, K.
Subjects: GLUCAGON-like peptide 1, CD26 antigen, CLINICAL trials, TYPE 2 diabetes, REGRESSION trees
Abstract: OBJECTIVE: To describe the individual and joint associations of baseline factors with glycemia, and also with differential effectiveness of medications added to metformin. RESEARCH DESIGN AND METHODS: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) participants (with type 2 diabetes diagnosed for <10 years, on metformin, and with HbA1c 6.8–8.5%; N = 5,047) were randomly assigned to a basal insulin (glargine), sulfonylurea (glimepiride), glucagon-like peptide 1 agonist (liraglutide), or dipeptidyl peptidase 4 inhibitor (sitagliptin). The glycemic outcome was HbA1c ≥7.0%, subsequently confirmed. Univariate and multivariate regression and classification and regression tree (CART) analyses were used to assess the association of baseline factors with the glycemic outcome at years 1 and 4. RESULTS: In univariate analyses at baseline, younger age (<58 years), Hispanic ethnicity, higher HbA1c, fasting glucose, and triglyceride levels, lower insulin secretion, and relatively greater insulin resistance were associated with the glycemic outcome at years 1 and/or 4. No factors were associated with differential effectiveness of the medications by year 4. In multivariate analyses, treatment group, younger age, and higher baseline HbA1c and fasting glucose were jointly associated with the glycemic outcome by year 4. The superiority of glargine and liraglutide at year 4 persisted after multiple baseline factors were controlled for. CART analyses indicated that failure to maintain HbA1c <7% by year 4 was more likely for younger participants and those with baseline HbA1c ≥7.4%. CONCLUSIONS: Several baseline factors were associated with the glycemic outcome but not with differential effectiveness of the four medications. Failure to maintain HbA1c <7% was largely driven by younger age and higher HbA1c at baseline. Factors that predict earlier glycemic deterioration could help in targeting patients for more aggressive management. [ABSTRACT FROM AUTHOR]
Published: 2024
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24. Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Author: Cherrington, Andrea L., Tripputi, Mark T., Younes, Naji, Herman, William H., Katona, Aimee, Groessl, Erik J., Craig, Jacqueline, Gonzalez, Jeffrey S., Garg, Rajesh, Casula, Sabina, Kuo, Shihchen, Florez, Hermes J., Crandall, J.P., McKee, M.D., Behringer-Massera, S., Brown-Friday, J., Xhori, E., Ballentine-Cargill, K., Duran, S., and Estrella, H.
Subjects: QUALITY of life, COMPARATIVE method, GLYCOSYLATED hemoglobin, TYPE 2 diabetes, DRUGS
Abstract: OBJECTIVE: Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS: A total of 5,047 participants, baseline mean age 57 years, with <10 years T2D duration and glycated hemoglobin level 6.8–8.5% and taking metformin monotherapy, were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline for 4,885 participants, and at years 1, 2, and 3, with use of the self-administered version of the Quality of Well-being Scale (QWB-SA) and SF-36 physical (PCS) and mental (MCS) component summary scales. Linear models were used to analyze changes in HRQoL over time in intention-to-treat analyses. RESULTS: None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at year 1 only. Greater weight loss during year 1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline BMI showed the greatest improvement in PCS scores at year 1. CONCLUSIONS: Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS in comparisons with the other medications at 1 year, which was no longer significant at years 2 and 3. Improvement was related to weight loss and baseline BMI. [ABSTRACT FROM AUTHOR]
Published: 2024
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25. Mortality in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Author: Banerji, Mary Ann, Buse, John B., Younes, Naji, Krause-Steinrauf, Heidi, Ghazi, Adline, Lee, Melissa, Park, Jean, Pop-Busui, Rodica, Underkofler, Chantal, Fortmann, Stephen P., Crandall, J.P., McKee, M.D., Behringer-Massera, S., Brown-Friday, J., Xhori, E., Ballentine-Cargill, K., Duran, S., Estrella, H., Gonzalez de la torre, S., and Lukin, J.
Subjects: COMPARATIVE method, DISEASE risk factors, MORTALITY, CAUSES of death, TYPE 2 diabetes
Abstract: OBJECTIVE: We report mortality outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) among people with type 2 diabetes diagnosed within 10 years and no recent history of cardiovascular events or cancer. RESEARCH DESIGN AND METHODS: Overall mortality rates and major causes of death were assessed over an average of 5 years of follow-up. Cause of death was adjudicated centrally by a committee masked to treatment assignment. We examined baseline covariates and the 10-year Framingham Risk Score for associations. RESULTS: Mortality rate was low (0.59 per 100 participant-years). Participants who died during follow-up were likely to be older, be male, have a history of hypertension, have a history of smoking, and have moderate albuminuria. The two most common underlying causes of death were "cardiovascular-cause" (a composite of underlying causes) (38.6%) and cancer (26.8%). There were no differences by treatment group. CONCLUSIONS: Among people with diabetes of relatively short duration, cause of death was varied. Attention to health risks beyond cardiovascular diseases is warranted. [ABSTRACT FROM AUTHOR]
Published: 2024
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26. Link-Based Models for Survival Data with Interval and Continuous Time Censoring

Author: Younes, Naji and Lachin, John
Published: 1997
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27. Glycemic Control and Urinary Tract Infections in Women with Type 1 Diabetes: Results from the DCCT/EDIC

Author: Nathan, D.M., Zinman, B., Crofford, O., Genuth, S., Brown-Friday, J., Crandall, J., Engel, H., Engel, S., Martinez, H., Phillips, M., Reid, M., Shamoon, H., Sheindlin, J., Gubitosi-Klug, R., Mayer, L., Pendegast, S., Zegarra, H., Miller, D., Singerman, L., Smith-Brewer, S., Novak, M., Quin, J., Genuth, Saul, Palmert, M., Brown, E., McConnell, J., Pugsley, P., Crawford, P., Dahms, W., Brillon, D., Lackaye, M.E., Kiss, S., Chan, R., Orlin, A., Rubin, M., Reppucci, V., Lee, T., Heinemann, M., Chang, S., Levy, B., Jovanovic, L., Richardson, M., Bosco, B., Dwoskin, A., Hanna, R., Barron, S., Campbell, R., Bhan, A., Kruger, D., Jones, J.K., Edwards, P.A., Carey, J.D., Angus, E., Thomas, A., Galprin, A., McLellan, M., Whitehouse, F., Bergenstal, R., Johnson, M., Gunyou, K., Thomas, L., Laechelt, J., Hollander, P., Spencer, M., Kendall, D., Cuddihy, R., Callahan, P., List, S., Gott, J., Rude, N., Olson, B., Franz, M., Castle, G., Birk, R., Nelson, J., Freking, D., Gill, L., Mestrezat, W., Etzwiler, D., Morgan, K., Aiello, L.P., Golden, E., Arrigg, P., Asuquo, V., Beaser, R., Bestourous, L., Cavallerano, J., Cavicchi, R., Ganda, O., Hamdy, O., Kirby, R., Murtha, T., Schlossman, D., Shah, S., Sharuk, G., Silva, P., Silver, P., Stockman, M., Sun, J., Weimann, E., Wolpert, H., Aiello, L.M., Jacobson, A., Rand, L., Rosenzwieg, J., Larkin, M.E., Christofi, M., Folino, K., Godine, J., Lou, P., Stevens, C., Anderson, E., Bode, H., Brink, S., Cornish, C., Cros, D., Delahanty, L., deManbey, A., Haggan, C., Lynch, J., McKitrick, C., Norman, D., Moore, D., Ong, M., Taylor, C., Zimbler, D., Crowell, S., Fritz, S., Hansen, K., Gauthier-Kelly, C., Service, F.J., Ziegler, G., Colligan, R., Schmidt, L., French, B., Woodwick, R., Rizza, R., Schwenk, W.F., Haymond, M., Pach, J., Mortenson, J., Zimmerman, B., Lucas, A., Luttrell, L., Lopes-Virella, M., Caulder, S., Pittman, C., Patel, N., Lee, K., Nutaitis, M., Fernandes, J., Hermayer, K., Kwon, S., Blevins, A., Parker, J., Colwell, J., Lee, D., Soule, J., Lindsey, P., Bracey, M., Farr, A., Elsing, S., Thompson, T., Selby, J., Lyons, T., Yacoub-Wasef, S., Szpiech, M., Wood, D., Mayfield, R., Molitch, M., Adelman, D., Colson, S., Jampol, L., Lyon, A., Gill, M., Strugula, Z., Kaminski, L., Mirza, R., Simjanoski, E., Ryan, D., Johnson, C., Wallia, A., Ajroud-Driss, S., Astelford, P., Leloudes, N., Degillio, A., Schaefer, B., Mudaliar, S., Lorenzi, G., Goldbaum, M., Jones, K., Prince, M., Swenson, M., Grant, I., Reed, R., Lyon, R., Kolterman, O., Giotta, M., Clark, T., Friedenberg, G., Sivitz, W.I., Vittetoe, B., Kramer, J., Bayless, M., Zeitler, R., Schrott, H., Olson, N., Snetselaar, L., Hoffman, R., MacIndoe, J., Weingeist, T., Fountain, C., Mendley, S., Johnsonbaugh, S., Patronas, M., Carney, M., Salemi, P., Liss, R., Hebdon, M., Counts, D., Donner, T., Gordon, J., Hemady, R., Kowarski, A., Ostrowski, D., Steidl, S., Jones, B., Herman, W.H., Martin, C.L., Pop-Busui, R., Greene, D.A., Stevens, M.J., Burkhart, N., Sandford, T., Floyd, J., Bantle, J., Wimmergren, N., Terry, J., Koozekanani, D., Montezuma, S., Rogness, B., Mech, M., Strand, T., Olson, J., McKenzie, L., Kwong, C., Goetz, F., Warhol, R., Hainsworth, D., Goldstein, D., Hitt, S., Giangiacomo, J., Schade, D.S., Canady, J.L., Burge, M.R., Das, A., Avery, R.B., Ketai, L.H., Chapin, J.E., Schluter, M.L., Rich, J., Johannes, C., Hornbeck, D., Schutta, M., Bourne, P.A., Brucker, A., Braunstein, S., Schwartz, S., Maschak-Carey, B.J., Baker, L., Orchard, T., Cimino, L., Songer, T., Doft, B., Olson, S., Becker, D., Rubinstein, D., Bergren, R.L., Fruit, J., Hyre, R., Palmer, C., Silvers, N., Lobes, L., Rath, P. Paczan, Conrad, P.W., Yalamanchi, S., J.Wesche, Bratkowksi, M., Arslanian, S., Rinkoff, J., Warnicki, J., Curtin, D., Steinberg, D., Vagstad, G., Harris, R., Steranchak, L., Arch, J., Kelly, K., Ostrosaka, P., Guiliani, M., Good, M., Williams, T., Olsen, K., Campbell, A., Shipe, C., Conwit, R., Finegold, D., Zaucha, M., Drash, A., Morrison, A., Malone, J.I., Bernal, M.L., Pavan, P.R., Grove, N., Tanaka, E.A., McMillan, D., Vaccaro-Kish, J., Babbione, L., Solc, H., DeClue, T.J., Dagogo-Jack, S., Wigley, C., Ricks, H., Kitabchi, A., Chaum, E., Murphy, M.B., Moser, S., Meyer, D., Iannacone, A., Yoser, S., Bryer-Ash, M., Schussler, S., Lambeth, H., Raskin, P., Strowig, S., Basco, M., Cercone, S., Barnie, A., Devenyi, R., Mandelcorn, M., Brent, M., Rogers, S., Gordon, A., Bakshi, N., Perkins, B., Tuason, L., Perdikaris, F., Ehrlich, R., Daneman, D., Perlman, K., Ferguson, S., Palmer, J., Fahlstrom, R., de Boer, I.H., Kinyoun, J., Van Ottingham, L., Catton, S., Ginsberg, J., McDonald, C., Harth, J., Driscoll, M., Sheidow, T., Mahon, J., Canny, C., Nicolle, D., Colby, P., Dupre, J., Hramiak, I., Rodger, N.W., Jenner, M., Smith, T., Brown, W., May, M., Hagan, J. Lipps, Agarwal, A., Adkins, T., Lorenz, R., Feman, S., Survant, L., White, N.H., Levandoski, L., Grand, G., Thomas, M., Joseph, D., Blinder, K., Shah, G., Burgess, D., Boniuk, I., Santiago, J., Tamborlane, W., Gatcomb, P., Stoessel, K., Ramos, P., Fong, K., Ossorio, P., Ahern, J., Beck, C., Gaston, P., Trail, R., Lachin, J., Cleary, P., Backlund, J., Bebu, I., Braffett, B., Diminick, L., Gao, X., Hsu, W., Klumpp, K., Larsen, M., McGee, P., Sun, W., Villavicencio, S., Anderson, K., Dews, L., Younes, Naji, Rutledge, B., Chan, K., Rosenberg, D., Petty, B., Determan, A., Kenny, D., Williams, C., Cowie, C., Siebert, C., Steffes, M., Arends, V., Bucksa, J., Nowicki, M., Chavers, B., O’Leary, D., Polak, J., Harrington, A., Funk, L., Crow, R., Gloeb, B., Thomas, S., O’Donnell, C., Soliman, E.Z., Zhang, Z.M., Li, Y., Campbell, C., Keasler, L., Hensley, S., Hu, J., Barr, M., Taylor, T., Prineas, R., Feldman, E.L., Albers, J.W., Low, P., Sommer, C., Nickander, K., Speigelberg, T., Pfiefer, M., Schumer, M., Moran, M., Farquhar, J., Ryan, C., Sandstrom, D., Geckle, M., Cupelli, E., Thoma, F., Burzuk, B., Woodfill, T., Danis, R., Blodi, B., Lawrence, D., Wabers, H., Gangaputra, S., Neill, S., Burger, M., Dingledine, J., Gama, V., Sussman, R., Davis, M., Hubbard, L., Budoff, M., Darabian, S., Rezaeian, P., Wong, N., Fox, M., Oudiz, R., Kim, L., Detrano, R., Cruickshanks, K., Dalton, D., Bainbridge, K., Lima, J., Bluemke, D., Turkbey, E., van der Geest, R.J., Liu, C., Malayeri, A., Jain, A., Miao, C., Chahal, H., Jarboe, R., Monnier, V., Sell, D., Strauch, C., Hazen, S., Pratt, A., Tang, W., Brunzell, J., Purnell, J., Natarajan, R., Miao, F., Zhang, L., Chen, Z., Paterson, A., Boright, A., Bull, S., Sun, L., Scherer, S., Lyons, T.J., Jenkins, A., Klein, R., Virella, G., Jaffa, A., Carter, R., Stoner, J., Garvey, W.T., Lackland, D., Brabham, M., McGee, D., Zheng, D., Mayfield, R.K., Maynard, J., Wessells, H., Sarma, A., Dunn, R., Holt, S., Hotaling, J., Kim, C., Clemens, Q., Brown, J., McVary, K., Lenherr, Sara M., Clemens, J. Quentin, Braffett, Barbara H., Cleary, Patricia A., Dunn, Rodney L., Hotaling, James M., Jacobson, Alan M., Kim, Catherine, Herman, William, Brown, Jeanette S., Wessells, Hunter, and Sarma, Aruna V.
Published: 2016
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28. Reassessing the effects of continuous positive airway pressure (CPAP) on arterial stiffness and peripheral blood derived CD34+ progenitor cells in subjects with sleep apnea

Author: Domingues, Cleyton C., Dore, Fiona J., Cho, Alexander, Ahmadi, Neeki, Kropotova, Yana, Kundu, Nabanita, Younes, Naji, Jain, Vivek, and Sen, Sabyasachi
Published: 2019
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29. Coronary angiographic and Echocardiographic findings in patients with Left bundle branch block

Author: Mohammed Younes Naji Al Atbee, Abd-Alumeer Abdulbari, Hasan Mohammed Al Rubaie, and Sarkis K. Strak
Subjects: Medicine
Abstract: Background and Objectives: Left bundle branch block is an electrical conduction disturbance that can be present with various cardiovascular diseases. Atherosclerosis is the most frequent underlying cause of ischemic heart disease with left bundle branch block. This study was carried out to analyze the angiographic and echocardiographic findings in patients with left bundle branch block. Left ventricular systolic function had also been assessed and correlated with measured QRS width and angiographic findings. Methods: A total of 100 patients with left bundle branch block, 66 males and 34 females, with a ratio of about 2:1 with an age ranged from 30-75years (mean age 58.5 ± 8.1 years). The study was conducted in Al-Sadr teaching hospital in Basrah, South of Iraq during the period from January 2009 to April 2010. Echocardiography was done for all patients to assess left ventricular function and regional wall motion abnormalities, Left ventricular systolic dysfunction was considered if the ejection fraction was less than 50%. The QRS width recorded from the ECG was calculated, and compared with echocardiographic and coronary angiographic findings. Coronary angiography was performed to define coronary lesions for all patients. Results: Fifty seven percent of patients had left bundle branch block of ischaemic origin and forty three percent of non ischaemic left bundle branch block. The predictors of ischaemic left bundle branch block were male, age older than 50 years, diabetes mellitus, and regional wall motion abnormalities. The QRS complex width as recorded from the ECG was predictor of left ventricular systolic dysfunction irrespective of other risk factors. Conclusion: Left bundle branch block was correlated with more extensive coronary heart disease and severe left ventricular dysfunction as studied by ECG, echocardiography and coronary angiography.
Published: 2015
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30. A Dynamic Risk Model for Multitype Recurrent Events

Author: Ghosh, Alokananda, primary, Chan, Wenyaw, additional, Younes, Naji, additional, and Davis, Barry R, additional
Published: 2022
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31. Androgens, Irregular Menses, and Risk of Diabetes and Coronary Artery Calcification in the Diabetes Prevention Program

Author: Kim, Catherine, Aroda, Vanita R, Goldberg, Ronald B, Younes, Naji, Edelstein, Sharon L, Carrion-Petersen, MaryLou, and Ehrmann, David A
Published: 2018
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32. Corrigendum to “The cross-sectional association of renal dysfunction with tests of cognition in middle-aged adults with early type 2 diabetes The GRADE Study” [J. Diabetes Complicat., 35 (3) (2021) 107805]

Author: Barzilay, Joshua I., primary, Younes, Naji, additional, Pop-Busui, Rodica, additional, Florez, Hermes, additional, Seaquist, Elizabeth, additional, Falck-Ytter, Corinna, additional, and Luchsinger, Jose A., additional
Published: 2022
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33. Cancer‐specific mortality, cure fraction, and noncancer causes of death among diffuse large B‐cell lymphoma patients in the immunochemotherapy era

Author: Howlader, Nadia, Mariotto, Angela B., Besson, Caroline, Suneja, Gita, Robien, Kim, Younes, Naji, and Engels, Eric A.
Published: 2017
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34. Prediagnostic Body Mass Index Trajectories in Relation to Prostate Cancer Incidence and Mortality in the PLCO Cancer Screening Trial

Author: Kelly, Scott P., Graubard, Barry I., Andreotti, Gabriella, Younes, Naji, Cleary, Sean D., and Cook, Michael B.
Published: 2017
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35. Geographic and income variations in age at diagnosis and incidence of chronic myeloid leukemia

Author: Mendizabal, Adam M., Younes, Naji, and Levine, Paul H.
Published: 2016
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36. Comparative Effects of Glucose-Lowering Medications on Kidney Outcomes in Type 2 Diabetes: The GRADE Randomized Clinical Trial.

Author: Wexler, Deborah J., de Boer, Ian H., Ghosh, Alokananda, Younes, Naji, Bebu, Ionut, Inzucchi, Silvio E., McGill, Janet B., Mudaliar, Sunder, Schade, David, Steffes, Michael W., Tamborlane, William V., Tan, Meng H., and Ismail-Beigi, Faramarz
Published: 2023
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37. Assessment of circulating insulin using liquid chromatography‐mass spectrometry during insulin glargine treatment in type 2 diabetes: Implications for estimating insulin sensitivity and β‐cell function.

Author: Seegmiller, Jesse C., Schmit, David J., Arends, Valerie L., Steffes, Michael W., Kahn, Steven E., and Younes, Naji
Subjects: INSULIN sensitivity, TYPE 2 diabetes, LIQUID chromatography-mass spectrometry, INSULIN therapy, CHEMILUMINESCENCE immunoassay
Abstract: Aim: To determine the potential impact of the cross‐reactivity of insulin glargine U‐100 and its metabolites on insulin sensitivity and β‐cell measures in people with type 2 diabetes. Materials and Methods: Using liquid chromatography–mass spectrometry (LC–MS), we measured concentrations of endogenous insulin, glargine and its two metabolites (M1 and M2) in fasting and oral glucose tolerance test‐stimulated plasma from 19 participants and fasting specimens from another 97 participants 12 months after randomization to receive the insulin glargine. The last dose of glargine was administered before 10:00 PM the night before testing. Insulin was also measured on these specimens using an immunoassay. We used fasting specimens to calculate insulin sensitivity (Homeostatic Model Assessment 2 [HOMA2]‐S%; QUICKI index; PREDIM index) and β‐cell function (HOMA2‐B%). Using specimens following glucose ingestion, we calculated insulin sensitivity (Matsuda ISI[comp] index) and β‐cell response (insulinogenic index [IGI], and total incremental insulin response [iAUC] insulin/glucose). Results: In plasma, glargine was metabolized to form the M1 and M2 metabolites that were quantifiable by LC–MS; however, the analogue and its metabolites cross‐reacted by less than 100% in the insulin immunoassay. This incomplete cross‐reactivity resulted in a systematic bias of fasting‐based measures. By contrast, because M1 and M2 did not change following glucose ingestion, a bias was not observed for IGI and iAUC insulin/glucose. Conclusions: Despite glargine metabolites being detected in the insulin immunoassay, dynamic insulin responses can be used to assess β‐cell responsiveness. However, given the cross‐reactivity of the glargine metabolites in the insulin immunoassay, fasting‐based measures of insulin sensitivity and β‐cell function are biased. [ABSTRACT FROM AUTHOR]
Published: 2023
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38. Islet Autoimmunity is Highly Prevalent and Associated With Diminished β-Cell Function in Patients With Type 2 Diabetes in the Grade Study

Author: Brooks-Worrell, Barbara, Hampe, Christiane S., Hattery, Erica G., Palomino, Brenda, Zangeneh, Sahar Z., Utzschneider, Kristina, Kahn, Steven E., Larkin, Mary E., Johnson, Mary L., Mather, Kieren J., Younes, Naji, Rasouli, Neda, Desouza, Cyrus, Cohen, Robert M., Park, Jean Y., Florez, Hermes J., Valencia, Willy Marcos, Shojaie, Ali, Palmer, Jerry P., Balasubramanyam, Ashok, Crandall, Jill P., McKee, Melissa Diane, Brown-Friday, Janet, Xhori, Entila, Ballentine-Cargill, Keisha, Duran, Sally, Lukin, Jennifer, Beringher, Stephanie, Gonzalez de la Torre, Susana, Phillips, Lawrence, Burgess, Elizabeth, Olson, Darin, Rhee, Mary, Wilson, Peter, Raines, Tasha Stephanie, Costello, Julie, Gullett, Chona, Maher-Albertelli, Maxine, Morehead, Folayan, Mungara, Radhika, Person, Saranjit, Savoye, Louise, Sibymon, Mabil, Tanukonda, Sridhar, White, Carol Ann, Holloway, Leah, Adams, Cynthia, Ross, April, Gonzalez Hattery, Erica, Gaba, Ruchi, Montes, Graciela, Wright, Charlyne, Hollander, Priscilla, Roe, Erin, Uy, Analyn, Burt, Polly, Estrada, Lorie, Chionh, Kris, Ismail-Beigi, Faramarz, Falck-Ytter, Corinna, Sayyed Kassem, Laure, Sood, Ajay, Tiktin, Margaret, Cramer, Bethany, Iacoboni, Jacalyn, Kononets, Maria V., Kulow, Tanya, Newman, Cynthia, Stancil, Katherine A., Sanders, Cristina, Tucker, Lisa, Werner, Amanda, Krol, Adrienne, McPhee, Gloria, Patel, Christine, Colosimo, Linda, Goland, Robin, Pring, James, Kringas, Patricia, Tejada, Jessica, Hausheer, Camille, Schneier, Harvey, Gumpel, Kelly, Kirpitch, Amanda, Green, Jennifer B., AbouAssi, Hiba, Chatterjee, Ranee, Feinglos, Mark N., English Jones, Jennifer, Khan, Shubi A., Kimpel, Jeanne B., Zimmer, Ronna P., Furst, Mary, Satterwhite, Barbara M., Thacker, Connie, Evans Kreider, Kathryn, Lteif, Amale, Hamilton, Tonya, Patel, Nick, Riera, Gabriela, Jackson, Marcia, Pirics, Vivian, Howard, Devin, Aguillar, Danielle, Hurt, Sloan, Bergenstal, Richard, Carlson, Anders, Martens, Thomas, Johnson, Mary, Hill, Renae, Hyatt, Jamie, Jensen, Connie, Madden, Marcia, Martin, Dianna, Willis, Holly, Konerza, Wanda, Passi, Rebecca, Kleeberger, Kathleen, Fortmann, Stephen, Herson, Michael, Mularski, Karen, Glauber, Harry, Prihoda, James, Ash, Britt, Carlson, Christina, Ramey, Phyllis Anne, Schield, Emily, Torgrimson-Ojerio, Britta, Arnold, Kathy, Kauffman, Bryan, Panos, Elease, Sahnow, Samantha, Bays, Kristi, Cook, Jennifer, Gluth, Jennifer, Sasaki, Debra, Schell, Katrina, Criscola, Jennifer, Friason, Camille, Jones, Suzi, Nazarov, Sergey, Barzilay, Joshua, Rassouli, Negah, Puttnam, Rachel, Curtis, Michelle, Stokes, Kia, Hollis, Bonita, Sanders-Jones, Cynthia, Nelson, Roslin, El-Haqq, Zakiah, Kolli, Abby, Tran, Tu, Wexler, Deborah, Larkin, Mary, Meigs, James, Dushkin, Amy, Rocchio, Gianna, Chambers, Brittany, Yepes, Mike, Steiner, Barbara, Dulin, Hilary, Cayford, Melody, DeManbey, Andrea, Gurry, Lindsey, Hillard, Mallory, Martin, Kimberly, Stevens, Christine, Thangthaeng, Nopporn, Kochis, Raquel, Raymond, Elyse, Ripley, Valerie, Park, Jean, Aroda, Vanita, Ghazi, Adline, Loveland, Amy, Hurtado, Maria, Kuhn, Alexander, Mofor, Florence, Marks, Jennifer, Oropesa-Gonzalez, Lisset, Riccio Veliz, Ana K., Nieto-Martinez, Ramfis, Gutt, Miriam, Ahmann, Andrew, Aby-Daniel, Diana, Joarder, Farahnaz, Morimoto, Victoria, Sprague, Carol, Yamashita, Daisuke, Cady, Nancy, Kirchhoff, Patricia, Rivera-Eschright, Nadia, Adducci, Joseph, Morales Gomez, Brianna, Goncharova, Alina, Hox, Sophia H., Petrovitch, Helen, Matwichyna, Michael, Jenkins, Victoria, Bermudez, Nina O., Ishii, Renée R., Hsia, Daniel S., Cefalu, William T., Greenway, Frank L., Waguespack, Celeste, King, Erin, Haynes, Natalie, Thomassie, Amy, Bourgeois, Brandi, Hazlett, Claire, Henry, Robert, Mudaliar, Sunder, Boeder, Schafer, Pettus, Jeremy, Diaz, Elsa, DeLue, Catherine, Castro, Erick, Hernandez, Sylvia, Krakoff, Jonathan, Curtis, Jeffrey M., Killean, Tina, Joshevama, Erica, Diaz, Enrique, Martin, Denelle, Karshner, Tracey, Albu, Jeanine, Pi-Sunyer, F. Xavier, Frances, Sylvaine, Maggio, Carol, Ellis, Emily, Bastawrose, Joseph, Gong, Xiuqun, Banerji, Mary Ann, August, Phyllis, Lorber, Daniel, Brown, Necole M., Josephson, Debra H., Thomas, Lorraine L., Tsovian, Mari, Cherian, Ajini, Jacobson, Marlo H., Mishko, Motria M., Kirkman, M. Sue, Bergamo, Katherine, Buse, John B., Dostou, Jean, Young, Laura, Goley, April, Kerr, Jeffrey, Largay, Joseph F., Guarda, Sonia, Cuffee, Juanita, Culmer, Dawn, Fraser, Rachael, Almeida, Hope, Coffer, Samantha, Debnam, Elizabeth, Kiker, Lauren, Morton, Sarah, Josey, Kim, Fuller, Gail, Garvey, W. Timothy, Cherrington, Andrea, Golson, Dana, Griffith, Olivia, Robertson, Mary Catherine, Agne, April, McCullars, Steve, Craig, Jacqueline, Kersey, Kimberly, Rogge, M. Colleen, Wilson, Carla, Burton, Kathryn, Lipp, Sonia, Vonder Meulen, Mary Beth, Schroeder, Emily, Steiner, Stephanie, Baker, Chelsea, Underkofler, Chantal, Douglass, Sara, Sivitz, William, Cline, Erin, Knosp, Laura, McConnell, Jennifer, Lowe, Tamara, Herman, William H., Pop-Busui, Rodica, Tan, Meng H., Martin, Catherine, Waltje, Andrea, Goodhall, Lynn, Eggleston, Rebecca, Kuo, Shihchen, Bule, Stephanie, Kessler, Nancy, LaSalle, Elizabeth, Seaquist, Elizabeth R., Bantle, Anne, Kumar, Anjali, Redmon, Bruce, Bantle, John, Harindhanavudhi, Tasma, Coe, Mary, Mech, Michael, Taddese, Abdisa, Lesne, Lesia, Smith, Shannon, Kuechenmeister, Lisa, Shivaswamy, Vijay, Morales, Ana Laura, Rodriguez, Maria Grace, Seipel, Kris, Alfred, Alissa, Eggert, Jenna, Lord, Grace, Taylor, William, Tillson, Renee, Schade, David S., Adolphe, Allen, Burge, Mark, Duran-Valdez, Elizabeth, Martinez, Janae, Hernandez McGinnis, Doris, Pucchetti, Benjamin, Scripsick, Elizabeth, DeFronzo, Ralph A., Cersosimo, Eugenio, Abdul-Ghani, Muhammad, Triplitt, Curtis, Verastiqui, Hector, Garza, Rosa Irene, Wright, Kathryn, Puckett, Curtiss, Raskin, Philip, Rhee, Chanhaeng, Abraham, Soma, Jordan, Lin Fan, Sao, Serey, Morton, Luisa, Smith, Oralenda, Osornio Walker, Laura, Schnurr-Breen, Laura, Ayala, Rosa, Kraymer, Robert, Sturgess, Daytheon, Utzschneider, Kristina M., Alarcon-Casas Wright, Lorena, Boyko, Edward, Tsai, Elaine C., Trence, Dace L., Fattaleh, Basma N., Montgomery, Brenda K., Atkinson, Karen M., Concepcion, Tessa, Kozedub, Alexandra, Moak, Cameron, Rhothisen, Samantha, Elasy, Tom A., Martin, Stephanie, Shackelford, Laura, Goidel, Rita, Hinkle, Nina, Lipps Hogan, Janie, Lovell, Cynthia, Myers, Janet, McGill, Janet B., Salam, Maamoun, Kissel, Sarah, Schweiger, Toni, Recklein, Carol, Tamborlane, William, Gatcomb, Patricia, Camp, Anne, Gulanski, Barbara, Inzucchi, Silvio, Pham, Kim, Alguard, Michele, Lessard, Katarzyna, Perez, Magalys, Magenheimer, Elizabeth, Montoza, Abmaridel, Nathan, David M., Lachin, John, Krause-Steinrauf, Heidi, Burch, Henry, Linder, Barbara, Bremer, Andrew, Backman, Michael, Bebu, Ionut, Buys, C.J., Fagan Murphy, Anna, Gao, Yuping, Gramzinski, Michaela, Hall, Stephanie, Legowski, Elizabeth, Arey, Alyssa, Bethepu, Joel, Lund, Claire, Mangat Dhaliwal, Pam, McGee, Paula, Mesimer, Emily, Ngo, Lisa, Steffes, Michael, Seegmiller, Jesse, Saenger, Amy, Arends, Valerie, Gabrielson, Deanna, Conner, Todd, Stuart, Warren, Day, Jolene, Scrymgeour, Alexandra, Soliman, Elsayed Z., Zhang, Zhu-Ming, Campbell, Charles, Hu, Julie, Keasler, Lisa, Hensley, Susan, Li, Yabing, Herman, William, Mihalcea, Rada, Perez-Rosas, Veronica, Prosser, Lisa, Resnicow, Kenneth, Ye, Wen, Shao, Hui, Zhang, Ping, Luchsinger, Jose, Sanchez, Danurys, Burch, Henry B., Fradkin, Judith, Groessl, Erik, Chong, Helen, Hillery, Naomi, Abdouch, Ivan, Brantley, Paula, Broyles, Frances E., Canaris, Gay, Copeland, Paul, Craine, Jeri J., Fein, Warren L., Lee, Melissa S., Meiners, Rebecca, Meiners, Vaughn, O’Neal, Hollis, Park, James E., Sledge, Edward, Steppel-Resnick, Jeanne, Turchin, Alexander, Higgins, John, Fischer, Lawrence, Golden, Sherita, Gonzalez, Jeffrey, Naik, Aanand, Walker, Elizabeth, Doner Lotenberg, Lynne, Gallivan, Joanne M., Lim, Joanne, Tuncer, Diane M., and Behringer-Massera, Stephanie
Subjects: endocrine system diseases, Diabetes Mellitus, Type 2, Endocrinology, Diabetes and Metabolism, Smoke, T-Lymphocytes, Internal Medicine, Humans, Pathophysiology, Fires
Abstract: Islet autoimmunity may contribute to β-cell dysfunction in type 2 diabetes (T2D). Its prevalence and clinical significance have not been rigorously determined. In this ancillary study to the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), we investigated the prevalence of cellular and humoral islet autoimmunity in patients with T2D duration of 4.0 ± 3.0 years (HbA1c 7.5 ± 0.5% on metformin alone). We measured T-cell autoreactivity against islet proteins, islet autoantibodies against 65-kDa GAD antigen, IA-2, and zinc transporter-8, and β-cell function. Cellular islet autoimmunity was present in 41.3%, humoral islet autoimmunity in 13.5%, and both in 5.3%. β-Cell function calculated as incremental area under the curve of glucose from 0–120 min (iAUC-CG) and ΔC-peptide(0–30)/Δglucose(0–30) from an oral glucose tolerance test was lower among T-cell–positive (T+) than T-cell–negative (T−) individuals using two different adjustments for insulin sensitivity (iAUC-CG: 13.2% [95% CI 0.3, 24.4] or 11.4% [95% CI 0.4, 21.2] lower; ΔC-peptide[0–30]/Δglucose[0–30]: 19% [95% CI 3.1, 32.3] or 17.7% [95% CI 2.6, 30.5%] lower). T+ patients had 17% higher HbA1c (95% CI 0.07, 0.28) and 7.7 mg/dL higher fasting plasma glucose levels (95% CI 0.2, 15.3) than T− patients. We conclude that islet autoimmunity is much more prevalent in patients with T2D than previously reported. T-cell–mediated autoimmunity is associated with diminished β-cell function and worse glycemic control.
Published: 2021

39. A Dynamic Risk Model for Multitype Recurrent Events.

Author: Ghosh, Alokananda, Chan, Wenyaw, Younes, Naji, and Davis, Barry R
Subjects: DISEASE relapse, RISK assessment, SURVIVAL analysis (Biometry), RESEARCH funding, STATISTICAL models, PROBABILITY theory, LONGITUDINAL method
Abstract: Recurrent events can occur more than once in the same individual; such events may be of different types, known as multitype recurrent events. They are very common in longitudinal studies. Often there is a terminating event, after which no further events can occur. The risk of any event, including terminating events such as death or cure, is typically affected by prior events. We propose a flexible joint multitype recurrent-events model that explicitly provides estimates of the change in risk for each event due to subject characteristics, including number and type of prior events and the absolute risk for every event type (terminating and nonterminating), and predicts event-free survival probability over a desired time period. The model is fully parametric, and therefore a standard likelihood function and robust standard errors can be constructed. We illustrate the model with applications to the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (1994–2002) and provide discussion of the results and model features. [ABSTRACT FROM AUTHOR]
Published: 2023
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40. Islet Autoimmunity is Highly Prevalent and Associated With Diminished β-Cell Function in Patients With Type 2 Diabetes in the Grade Study

Author: Brooks-Worrell, Barbara, primary, Hampe, Christiane S., primary, Hattery, Erica G., primary, Palomino, Brenda, primary, Zangeneh, Sahar Z., primary, Utzschneider, Kristina, primary, Kahn, Steven E., primary, Larkin, Mary E., primary, Johnson, Mary L., primary, Mather, Kieren J., primary, Younes, Naji, primary, Rasouli, Neda, primary, Desouza, Cyrus, primary, Cohen, Robert M., primary, Park, Jean Y., primary, Florez, Hermes J., primary, Valencia, Willy Marcos, primary, Network, GRADE Beta-cell Ancillary Study, primary, Shojaie, Ali, primary, Palmer, Jerry P., primary, Balasubramanyam, Ashok, primary, and Group, GRADE Research, primary
Published: 2022
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41. Reduced levels of genital tract immune biomarkers in postmenopausal women: implications for HIV acquisition

Author: Jais, Mariel, Younes, Naji, Chapman, Stacey, Cu-Uvin, Susan, and Ghosh, Mimi
Published: 2016
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42. Shape of the OGTT glucose response curve: relationship with β-cell function and differences by sex, race, and BMI in adults with early type 2 diabetes treated with metformin

Author: Utzschneider, Kristina M, primary, Younes, Naji, additional, Rasouli, Neda, additional, Barzilay, Joshua I, additional, Banerji, Mary Ann, additional, Cohen, Robert M, additional, Gonzalez, Erica V, additional, Ismail-Beigi, Faramarz, additional, Mather, Kieren J, additional, Raskin, Philip, additional, Wexler, Deborah J, additional, Lachin, John M, additional, and Kahn, Steven E, additional
Published: 2021
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43. Placebo response in relation to clinical trial design: a systematic review and meta-analysis of randomized controlled trials for determining biologic efficacy in psoriasis treatment

Author: Lamel, Sonia A., Myer, Kaley A., Younes, Naji, Zhou, James A., Maibach, Hilda, and Maibach, Howard I.
Published: 2012
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44. Second primary breast, endometrial, and ovarian cancers in Black and White breast cancer survivors over a 35-year time span: effect of age

Author: Nsouli-Maktabi, Hala H., Henson, Donald E., Younes, Naji, Young, Heather A., and Cleary, Sean D.
Published: 2011
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45. Association of Glycemia, Lipids, and Blood Pressure With Cognitive Performance in People With Type 2 Diabetes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study

Author: Luchsinger, José A., primary, Younes, Naji, primary, Manly, Jennifer J., primary, Barzilay, Joshua, primary, Valencia, Willy, primary, Larkin, Mary E., primary, Falck-Ytter, Corinna, primary, Krause-Steinrauf, Heidi, primary, Pop-Busui, Rodica, primary, Florez, Hermes, primary, Seaquist, Elizabeth, primary, and Group, the GRADE Research, primary
Published: 2021
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46. Association of Baseline Characteristics With Insulin Sensitivity and β-Cell Function in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study Cohort

Author: Rasouli, Neda, Younes, Naji, Utzschneider, Kristina M, Inzucchi, Silvio E, Balasubramanyam, Ashok, Cherrington, Andrea L, Ismail-Beigi, Faramarz, Cohen, Robert M, Olson, Darin E, DeFronzo, Ralph A, Herman, William H, Lachin, John M, Kahn, Steven E, and GRADE Research Group
Subjects: Blood Glucose, Male, C-Peptide, Prevention, Diabetes, Infant, nutritional and metabolic diseases, GRADE Research Group, Medical and Health Sciences, Endocrinology & Metabolism, Cross-Sectional Studies, Clinical Research, Diabetes Mellitus, Humans, Insulin, Female, Insulin Resistance, Child, Preschool, Type 2, Metabolic and endocrine
Abstract: Objective: We investigated sex and racial differences in insulin sensitivity, β-cell function and HbA1c, and the associations with selected phenotypic characteristics. Research Design and Methods: This is a cross-sectional analysis of baseline data from 3,108 GRADE participants. All had type 2 diabetes diagnosed Results: The cohort was 56.6±10 years of age (mean±SD), 63.8% male, with BMI 34.2±6.7 kg/m2, HbA1c 7.5±0.5% and type 2 diabetes duration 4.0±2.8 years. Women had higher DI than men but similar insulin sensitivity. DI was the highest in Black/African Americans, followed by American Indians/Alaska Natives, Asians and Whites in descending order. Compared to white, American Indian/Alaska Native had significantly higher HbA1c but Black/African Americans and Asians had lower HbA1c. However, when adjusted for glucose levels, Black/African Americans had higher HbA1c than whites. Insulin sensitivity correlated inversely with BMI, waist to hip ratio, triglyceride to HDL cholesterol ratio (TG/HDL- C) and the presence of metabolic syndrome; whereas DI was associated directly with age and inversely with BMI, HbA1c and TG/HDL-C. Conclusion: In the GRADE cohort, β-cell function differed by sex and race and was associated with the concurrent level of HbA1c. HbA1c also differed among the races, but not sex. Age, BMI and TG/HDL-C were associated with multiple measures of β-cell function and insulin sensitivity.
Published: 2020
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47. The cross-sectional association of renal dysfunction with tests of cognition in middle-aged adults with early type 2 diabetes: The GRADE Study

Author: Barzilay, Joshua I, Younes, Naji, Busui, Rodica Pop, Florez, Hermes, Seaquist, Elizabeth, Falck-Ytter, Corinna, and Luchsinger, Jose A
Subjects: Cognition, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Albumins, Albuminuria, Humans, Middle Aged, Renal Insufficiency, Chronic, Cognition Disorders, Article, Glomerular Filtration Rate
Abstract: OBJECTIVE: The association of renal dysfunction with tests of cognition in type 2 diabetes has been examined in individuals with moderate and advanced renal disease. Here we examine the association of renal dysfunction with tests of cognition in a cohort of middle-aged adults with short duration diabetes (mean 4.0±2.8 years). METHODS: Baseline data were examined from the Glycemia Reduction Approaches in Diabetes (GRADE) study (n=4998). Renal dysfunction was defined by the presence of albumin in the urine or by estimated glomerular filtration rate (eGFR). Cognition was assessed with the Spanish English Verbal Learning Test, Letter and Animal fluency tests, and the Digit Symbol Substitution Test. RESULTS: Participants with albuminuria or eGFR
Published: 2020

48. Treatment utilization for endometriosis symptoms: a cross-sectional survey study of lifetime experience

Author: Sinaii, Ninet, Cleary, Sean D., Younes, Naji, Ballweg, Mary Lou, and Stratton, Pamela
Published: 2007
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49. Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial.

Author: Waters, David D., Alderman, Edwin L., Hsia, Judith, Howard, Barbara V., Cobb, Frederick R., Rogers, William J., Ouyang, Pamela, Thompson, Paul, Tardif, Jean Claude, Higginson, Lyall, Bittner, Vera, Steffes, Michael, Gordon, David J., Proschan, Michael, Younes, Naji, and Verter, Joel I.
Subjects: Antioxidants -- Health aspects, Vitamins -- Health aspects, Coronary heart disease -- Development and progression, Hormone therapy -- Evaluation
Abstract: Neither hormone replacement therapy (HRT) nor antioxidant vitamins can slow the progression of coronary artery disease, according to a study of 423 postmenopausal women with coronary artery disease. In fact, HRT and vitamins appeared to make the disease progress faster. This was documented by angiography, a technique that can measure the inside of the coronary arteries.
Published: 2002

50. Islet Autoimmunity is Highly Prevalent and Associated With Diminished Beta-Cell Function in Patients With Type 2 Diabetes in the Grade Study

Author: Brooks-Worrell, Barbara, primary, Hampe, Christiane S., additional, Hattery, Erica G., additional, Palomino, Brenda, additional, Zangeneh, Sahar Z., additional, Utzschneider, Kristina, additional, Kahn, Steven E., additional, Larkin, Mary E., additional, Johnson, Mary L., additional, Mather, Kieren J., additional, Younes, Naji, additional, Rasouli, Neda, additional, Desouza, Cyrus, additional, Cohen, Robert M., additional, Park, Jean Y., additional, Florez, Hermes J., additional, Valencia, Willy Marcos, additional, Network, GRADE Beta-cell Ancillary Study, additional, Shojaie, Ali, additional, Palmer, Jerry P., additional, Balasubramanyam, Ashok, additional, and Group, GRADE Research, additional
Published: 2021
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