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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, 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

4. 1141-P: Detailed Phenotype of Randomized Participants by Age in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Author

ARODA, VANITA R., KRAUSE-STEINRAUF, HEIDI, BUSE, JOHN B., GULANSKI, BARBARA I., FLOREZ, HERMES, AHMANN, ANDREW J., LOVELAND, AMY, KUHN, ALEXANDER, LONIER, JACQUELINE, MATHER, KIEREN J., and WEXLER, DEBORAH J.

Abstract

Background: GRADE enrolled 5,047 adults > 30 years, T2DM < 10 years duration, on metformin, requiring a second medication, A1C 6.8-8.5%. Age-related differences in disease phenotype may affect responses to the randomized treatments being evaluated. Objective: To evaluate whether baseline characteristics differed by age. Methods: Baseline characteristics were compared across age groups, using mean ± SD (ANOVA) or % (Pearson's chi-square). We report nominal, unadjusted p-values. Results: With the defined inclusion criteria, we enrolled a cohort with overall DM duration 4.2 ± 2.8 years, and A1c 7.5 ± 0.5%. Within this cohort, distinct clinical phenotypes by age were present. Across the age groups, older individuals had more CVD, and were on more medications for DM-related comorbidities. Younger individuals were more diverse, had higher weight, FPG, and insulin, more pronounced diabetic dyslipidemia, and were taking fewer medications for comorbidities (Table). Conclusion: Within the GRADE cohort defined by inclusion criteria representing a specific stage of glycemia, the clinical phenotype of T2DM differed by age, with older participants having greater prevalent comorbidity and younger participants having more prominent hyperglycemia and higher weight. An understanding of the distinct phenotypes by age may identify priorities and gaps in clinical care. Disclosure: V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. H. Krause-Steinrauf: None. J.B. Buse: Consultant; Self; Neurimmune AG. Research Support; Self; AstraZeneca, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg, Novo Nordisk A/S, Senseonics, vTv Therapeutics, Zafgen, Inc. B.I. Gulanski: None. H. Florez: None. A.J. Ahmann: Advisory Panel; Self; Eli Lilly and Company, MannKind Corporation, Novo Nordisk Inc., Sanofi-Aventis. Consultant; Self; Dexcom, Inc. Research Support; Self; Dexcom, Inc., Medtronic. A. Loveland: None. A. Kuhn: None. J. Lonier: None. K.J. Mather: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. D.J. Wexler: Other Relationship; Spouse/Partner; APOLO1BIO. Funding: National Institute of Diabetes and Digestive and Kidney Diseases [ABSTRACT FROM AUTHOR]

Published
2019
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5. Nutritional Intervention to Prevent (NIP) Type 1 Diabetes.

Author

Chase, H. Peter, Asare, Smita, Greenbaum, Carla, Lachin, John, Leschek, Ellen, Krause-Steinrauf, Heidi, Rafkin-Mervis, Lisa, and Clare-Salzler, Michael

Subjects
NUTRITION, DIABETES prevention, DIABETES in children, THERAPEUTICS, FEASIBILITY studies, INFANTS, DOCOSAHEXAENOIC acid, AUTOANTIBODIES
Abstract

Evidence for the initiation of type 1 diabetes (T1D) early in life comes from studies demonstrating 80% of children who develop this disease before the age of 12 years manifest autoantibodies prior to age 3 years. T1D prevention therefore may be most successful when treatments are begun at an early age. However, such interventions must be safe and not interfere with the growth and development of infants. A pilot feasibility trial to prevent the initiation of islet inflammation in high-risk infants has been initiated by Type 1 Diabetes TrialNet in which 90 infants from 10 clinical sites will receive docosahexaenoic acid (DHA), an omega 3 fatty acid, or a placebo. In human studies, supplementation with DHA effectively reduced inflammatory responses, e.g., IL-1b (beta) and IL-12, and blocked Th1 responses, thus targeting key immuno-pathogenie events that may block or reduce early β (beta) cell destruction. In the current study, DHA (or placebo) is either given to pregnant mothers in their third trimester of pregnancy (Group A) or administered to infants within the first 6 months after birth (Group B). In order to continue (Group A) or enter (Group B) the one year pilot trial, infants must have a family history of T1D and must express high-risk HLA alleles. The goals of the trial are; i) enroll 90 subjects in 12 months, ii) demonstrate 90/95% compliance in visits/taking supplement, iii) demonstrate DHA supplementation increases RBC DHA levels by greater than or equal to 20%, iv) demonstrate DHA supplementation reduces inflammatory cytokine production, e.g. IL-1β (beta), by greater than or equal to 20%, and v) demonstrate DHA supplementation does not interfere with immunity. Upon reaching these goals a full trial would ensue where infants will receive DHA supplements until age 3 years. Annual follow-up will occur until age 6 years with contact to age 9 years. The study endpoint will be the development of 2 persistent biochemical islet autoantibodies. AIDA-Funded Research [ABSTRACT FROM AUTHOR]

Published
2007

6. The Prevalence of Glucose Tolerance Abnormalities According to Autoantibody Number in the TrialNet Natural History Study.

Author

Mahon, Jeffrey, Sosenko, Jay, Lachin, John, Krause-Steinrauf, Heidi, Rafkin-Mervis, Lisa, Eisenbarth, George, Palmer, Jerry, Thompson, Clinton, and Skyler, Jay

Subjects
DIABETES prevention, PANCREATIC beta cells, AUTOANTIBODIES, GLUCOSE, PEOPLE with diabetes, GLUCOSE tolerance tests
Abstract

Type 1 Diabetes TrialNet is an international research consortium whose objective is to develop interventions to delay or prevent type 1 diabetes (T1D) and to slow the loss of Beta cell function once it is diagnosed. The Natural History Study (NHS) is a core element of TrialNet, since participants (relatives of T1D patients) must first be screened positive for autoantibodies (confirmation requires positivity on 2 separate samples) and are then staged for T1D risk with 2-hr OGTTs before they can be considered for entry into a prevention trial. Data are shown from the NHS regarding associations between glucose tolerance abnormalities and autoantibody number. Of 416 participants who have been confirmed positive for at least 1 of 3 biochemical autoantibodies (GAD65, ICA512, mIAA) and have undergone baseline 2-hr OGTTs, 260 have had 1 positive autoantibody (1-abpos) and 156 have had 2 positive autoantibodies (≥ 2-abpos). Participants with ≥ 2-abpos were markedly younger than those with 1-abpos (mean±SD: 11.5±9.9 years vs 22.9±14.9 years, p<0.001). Those with ≥ 2-abpos had a significantly higher percentage of glucose levels in the diabetic range (10.3% vs. 4.2%, p=0.016) than those with 1-abpos. Of those in the non-diabetic range (n=249 for 1-abpos and n=140 for ≥ 2-abpos), the percentage with impaired glucose tolerance (IGT) was also higher in those with ≥ 2-abpos (22.1% vs 14.1%, p=0.041). Conversely, there was a lower percentage of impaired fasting glucose (IFG) in those with ≥ 2-abpos (8.6% vs 15.7%, p=0.047). In a stratified analysis, this pattern of differences persisted in those <13 years of age (n=216). Thus, in that age group, those with ≥ 2-abpos had higher percentages of diabetic range glucose levels (p=0.004) and IGT (p<0.001). The lower percentage of IFG in those with ≥ 2-abpos was again apparent (p=0.028). There were no significant differences for any glucose abnormality according to number of positive autoantibodies in those ≥ 13 years. These data suggest that in younger children, glucose levels in the diabetic range and IGT are more commonly present in those with multiple positive autoantibodies than in those with a single positive autoantibody. However, in contrast, it appears that in the same age group, IFG is less common in those with multiple autoantibodies than in those with a single positive autoantibody. [ABSTRACT FROM AUTHOR]

Published
2007

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