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1. Effects of Long-term Metformin and Lifestyle Interventions on Cardiovascular Events in the Diabetes Prevention Program and Its Outcome Study

Author

Goldberg, Ronald B, Orchard, Trevor J, Crandall, Jill P, Boyko, Edward J, Budoff, Matthew, Dabelea, Dana, Gadde, Kishore M, Knowler, William C, Lee, Christine G, Nathan, David M, Watson, Karol, and Temprosa, Marinella

Subjects
Health Services and Systems, Biomedical and Clinical Sciences, Health Sciences, Cardiovascular, Atherosclerosis, Diabetes, Prevention, Clinical Research, Nutrition, Heart Disease, Clinical Trials and Supportive Activities, Heart Disease - Coronary Heart Disease, Aging, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Prevention of disease and conditions, and promotion of well-being, Good Health and Well Being, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Life Style, Metformin, Myocardial Infarction, Outcome Assessment, Health Care, cardiovascular diseases, diabetes mellitus, type 2, metformin, Diabetes Prevention Program Research Group*, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences, Sports science and exercise
Abstract

BackgroundLifestyle intervention and metformin have been shown to prevent diabetes; however, their efficacy in preventing cardiovascular disease associated with the development of diabetes is unclear. We examined whether these interventions reduced the incidence of major cardiovascular events over a 21-year median follow-up of participants in the DPP trial (Diabetes Prevention Program) and DPPOS (Diabetes Prevention Program Outcomes Study).MethodsDuring DPP, 3234 participants with impaired glucose tolerance were randomly assigned to metformin 850 mg twice daily, intensive lifestyle or placebo, and followed for 3 years. During the next 18-year average follow-up in DPPOS, all participants were offered a less intensive group lifestyle intervention, and unmasked metformin was continued in the metformin group. The primary outcome was the first occurrence of nonfatal myocardial infarction, stroke, or cardiovascular death adjudicated by standard criteria. An extended cardiovascular outcome included the primary outcome or hospitalization for heart failure or unstable angina, coronary or peripheral revascularization, coronary heart disease diagnosed by angiography, or silent myocardial infarction by ECG. ECGs and cardiovascular risk factors were measured annually.ResultsNeither metformin nor lifestyle intervention reduced the primary outcome: metformin versus placebo hazard ratio 1.03 (95% CI, 0.78-1.37; P = 0.81) and lifestyle versus placebo hazard ratio 1.14 (95% CI, 0.87-1.50; P = 0.34). Risk factor adjustment did not change these results. No effect of either intervention was seen on the extended cardiovascular outcome.ConclusionsNeither metformin nor lifestyle reduced major cardiovascular events in DPPOS over 21 years despite long-term prevention of diabetes. Provision of group lifestyle intervention to all, extensive out-of-study use of statin and antihypertensive agents, and reduction in the use of study metformin together with out-of-study metformin use over time may have diluted the effects of the interventions.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifiers: DPP (NCT00004992) and DPPOS (NCT00038727).

Published
2022

2. Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2)

Author

Navas-Acien, Ana, Santella, Regina M., Joubert, Bonnie R., Huang, Zhen, Lokhnygina, Yuliya, Ujueta, Francisco, Gurvich, Irina, LoIacono, Nancy J., Ravalli, Filippo, Ward, Cynthia D., Jarrett, Jeffery M., Salazar, Alfonsina De Leon, Boineau, Robin, Jones, Teresa L.Z., Mark, Daniel B., Newman, Jonathan D., Nathan, David M., Anstrom, Kevin J., and Lamas, Gervasio A.

Published
2024
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4. Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring

Author

Larkin, Mary E, Nathan, David M, Bebu, Ionut, Krause-Steinrauf, Heidi, Herman, William H, Higgins, John M, Tiktin, Margaret, Cohen, Robert M, Lund, Claire, Bergenstal, Richard M, Johnson, Mary L, Arends, Valerie, 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, 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, Falck-Ytter, Corinna, Kassem, Laure Sayyed, 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, 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, Carlson, Anders, Martens, Thomas, and Johnson, Mary

Subjects
Diabetes, Clinical Research, Metabolic and endocrine, Black or African American, Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hispanic or Latino, Humans, Hypoglycemic Agents, Randomized Controlled Trials as Topic, Research Design, White People, Type 2 diabetes, Glycated hemoglobin, Interracial differences, Continuous glucose monitoring, Average glucose, GRADE Research Group, Clinical Sciences, Medical Physiology, Endocrinology & Metabolism
Abstract

Background: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. Methods: The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations. Conclusions: The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.

Published
2019

5. The trial to assess chelation therapy 2 (TACT2): Rationale and design

Author

Lamas, Gervasio A., Anstrom, Kevin J., Navas-Acien, Ana, Boineau, Robin, Kim, Hwasoon, Rosenberg, Yves, Stylianou, Mario, Jones, Teresa L.Z., Joubert, Bonnie R., Santella, Regina M., Escolar, Esteban, Aude, Y. Wady, Fonseca, Vivian, Elliott, Thomas, Lewis, Eldrin F., Farkouh, Michael E., Nathan, David M., Mon, Ana C., Gosnell, Leigh, Newman, Jonathan D., and Mark, Daniel B.

Published
2022
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6. 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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7. Concussion burden and later‐life cardiovascular risk factors in former professional American‐style football players

Author

Tan, Can Ozan, primary, Grashow, Rachel, additional, Thorpe, Roland, additional, Miller, Karen K., additional, Nathan, David M., additional, Izzy, Saef, additional, Radmanesh, Farid, additional, Kim, Jonathan H., additional, Weisskopf, Marc G., additional, Taylor, Herman A., additional, Zafonte, Ross D., additional, and Baggish, Aaron L., additional

Published
2024
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9. Edetate Disodium–Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial.

Author

Lamas, Gervasio A., Anstrom, Kevin J., Navas-Acien, Ana, Boineau, Robin, Nemeth, Hayley, Huang, Zhen, Wen, Jun, Rosenberg, Yves, Stylianou, Mario, Jones, Teresa L. Z., Joubert, Bonnie R., Yu, Qilu, Santella, Regina M., Mon, Ana C., Ujueta, Francisco, Escolar, Esteban, Nathan, David M., Fonseca, Vivian A., Aude, Y. Wady, and Ehrman, Jonathan K.

Subjects
MAJOR adverse cardiovascular events, MYOCARDIAL infarction, CORONARY artery disease, MINERAL supplements, CHELATION therapy
Abstract

Key Points: Question: Does therapy with edetate disodium (EDTA)–based chelation reduce major adverse cardiovascular events compared with placebo infusions among patients with diabetes and prior myocardial infarction (MI)? Findings: EDTA-based chelation did not reduce major adverse cardiovascular events compared with placebo infusion, with a hazard ratio of 0.93 (95% CI, 0.76-1.16; P =.53). Chelation infusions did reduce the median blood lead levels from 9.0 μg/L at baseline to 3.5 μg/L at infusion 40 (P <.001). Meaning: Among patients with diabetes and prior MI, EDTA-based chelation decreased median blood lead levels by 61% from baseline but did not reduce major adverse cardiovascular events. Importance: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)–based chelation significantly reduced cardiovascular disease (CVD) events by 18% in 1708 patients with a prior myocardial infarction (MI). Objective: To replicate the finding of TACT in individuals with diabetes and previous MI. Design, Setting, and Participants: A 2 × 2 factorial, double-masked, placebo-controlled, multicenter trial at 88 sites in the US and Canada, involving participants who were 50 years or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment compared the effect of EDTA-based chelation vs placebo infusions on CVD events and compared the effect of high doses of oral multivitamins and minerals with oral placebo. This article reports on the chelation vs placebo infusion comparisons. Interventions: Eligible participants were randomly assigned to 40 weekly infusions of an EDTA-based chelation solution or matching placebo and to twice daily oral, high-dose multivitamin and mineral supplements or matching placebo for 60 months. This article addresses the chelation study. Main Outcomes and Measures: The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Median follow-up was 48 months. Primary comparisons were made from patients who received at least 1 assigned infusion. Results: Of the 959 participants (median age, 67 years [IQR, 60-72 years]; 27% females; 78% White, 10% Black, and 20% Hispanic), 483 received at least 1 chelation infusion and 476 at least 1 placebo infusion. A primary end point event occurred in 172 participants (35.6%) in the chelation group and in 170 (35.7%) in the placebo group (adjusted hazard ratio [HR], 0.93; 95% CI, 0.76-1.16; P =.53). The 5-year primary event cumulative incidence rates were 45.8% for the chelation group and 46.5% for the placebo group. CV death, MI, or stroke events occurred in 89 participants (18.4%) in the chelation group and in 94 (19.7%) in the placebo group (adjusted HR, 0.89; 95% CI, 0.66-1.19). Death from any cause occurred in 84 participants (17.4%) in the chelation group and in 84 (17.6%) in the placebo group (adjusted HR, 0.96; 95% CI, 0.71-1.30). Chelation reduced median blood lead levels from 9.03 μg/L at baseline to 3.46 μg/L at infusion 40 (P <.001). Corresponding levels in the placebo group were 9.3 μg/L and 8.7 μg/L, respectively. Conclusions and Relevance: Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI. Trial Registration: ClinicalTrials.gov Identifier: NCT02733185 This randomized clinical trial assesses whether edetate disodium–based chelation infusions decrease cardiovascular disease events compared with placebo among patients with diabetes and prior myocardial infarction. [ABSTRACT FROM AUTHOR]

Published
2024
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10. History of the Diabetes Control and Complications Trial and Its Follow-up Epidemiology of Diabetes Interventions and Complications Study: Studies That Changed the Treatment of Type 1 Diabetes.

Author

Nathan, David M. and Lachin, John M.

Subjects
*CONTINUOUS glucose monitoring, *DIGESTIVE system diseases, *DIABETES in children, *TYPE 1 diabetes, *GLYCEMIC control, *INSULIN pumps, *HYPERGLYCEMIA, *DIABETIC retinopathy, *PATIENT self-monitoring
Abstract

The article discusses the Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC). It explains how the DCCT demonstrated that intensive treatment of type 1 diabetes reduced the risk of microvascular complications, such as retinopathy, neuropathy, and albuminuria. However, it also found that intensive treatment had adverse effects, including an increase in severe hypoglycemia. The EDIC study showed that the benefits of intensive treatment persisted over time, leading to reductions in severe complications and mortality. The findings of these studies have greatly influenced diabetes treatment guidelines and improved outcomes for people with type 1 diabetes. [Extracted from the article]

Published
2024
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12. Estimating Glycemia From HbA1c and CGM: Analysis of Accuracy and Sources of Discrepancy

Author

Tozzo, Veronica, primary, Genco, Matthew, additional, Omololu, Shammah O., additional, Mow, Christopher, additional, Patel, Hasmukh R., additional, Patel, Chhaya H., additional, Ho, Samantha N., additional, Lam, Evie, additional, Abdulsater, Batoul, additional, Patel, Nikita, additional, Cohen, Robert M., additional, Nathan, David M., additional, Powe, Camille E., additional, Wexler, Deborah J., additional, and Higgins, John M., additional

Published
2024
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15. Estimating Glycemia From HbA1c and CGM: Analysis of Accuracy and Sources of Discrepancy.

Author

Tozzo, Veronica, Genco, Matthew, Omololu, Shammah O., Mow, Christopher, Patel, Hasmukh R., Patel, Chhaya H., Ho, Samantha N., Lam, Evie, Abdulsater, Batoul, Patel, Nikita, Cohen, Robert M., Nathan, David M., Powe, Camille E., Wexler, Deborah J., and Higgins, John M.

Subjects
CONTINUOUS glucose monitoring, ERYTHROCYTES, TYPE 1 diabetes, CELLULAR aging, UNITS of measurement
Abstract

OBJECTIVE: To examine the accuracy of different periods of continuous glucose monitoring (CGM), hemoglobin A1c (HbA1c), and their combination for estimating mean glycemia over 90 days (AG90). RESEARCH DESIGN AND METHODS: We retrospectively studied 985 CGM periods of 90 days with <10% missing data from 315 adults (86% of whom had type 1 diabetes) with paired HbA1c measurements. The impact of mean red blood cell age as a proxy for nonglycemic effects on HbA1c was estimated using published theoretical models and in comparison with empirical data. Given the lack of a gold standard measurement for AG90, we applied correction methods to generate a reference (eAG90) that we used to assess accuracy for HbA1c and CGM. RESULTS: Using 14 days of CGM at the end of the 90-day period resulted in a mean absolute error (95th percentile) of 14 (34) mg/dL when compared with eAG90. Nonglycemic effects on HbA1c led to a mean absolute error for average glucose calculated from HbA1c of 12 (29) mg/dL. Combining 14 days of CGM with HbA1c reduced the error to 10 (26) mg/dL. Mismatches between CGM and HbA1c >40 mg/dL occurred more than 5% of the time. CONCLUSIONS: The accuracy of estimates of eAG90 from limited periods of CGM can be improved by averaging with an HbA1c-based estimate or extending the monitoring period beyond ∼26 days. Large mismatches between eAG90 estimated from CGM and HbA1c are not unusual and may persist due to stable nonglycemic factors. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Delayed Gastric Emptying Is Associated With Early and Long-term Hyperglycemia in Type 1 Diabetes Mellitus

Author

Bharucha, Adil E., Batey-Schaefer, Barbara, Cleary, Patricia A., Murray, Joseph A., Cowie, Catherine, Lorenzi, Gayle, Driscoll, Marsha, Harth, Judy, Larkin, Mary, Christofi, Marielle, Bayless, Margaret, Wimmergren, Nyra, Herman, William, Whitehouse, Fred, Jones, Kim, Kruger, Davida, Martin, Cathy, Ziegler, Georgia, Zinsmeister, Alan R., and Nathan, David M.

Published
2015
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22. Partial Meal Replacement Plan and Quality of the Diet at 1 Year: Action for Health in Diabetes (Look AHEAD) Trial

Author

Brancati, Frederick L., Honas, Jeff, Cheskin, Lawrence, Clark, Jeanne M., Stewart, Kerry, Rubin, Richard, Charleston, Jeanne, Horak, Kathy, Bray, George A., Rau, Kristi, Strate, Allison, Armand, Brandi, Greenway, Frank L., Ryan, Donna H., Williamson, Donald, Bachand, Amy, Begnaud, Michelle, Berhard, Betsy, Caderette, Elizabeth, Cerniauskas, Barbara, Creel, David, Crow, Diane, Guay, Helen, Kora, Nancy, LaFleur, Kelly, Landry, Kim, Lingle, Missy, Perault, Jennifer, Shipp, Mandy, Smith, Marisa, Tucker, Elizabeth, Lewis, Cora E., Thomas, Sheikilya, Safford, Monika, DiLillo, Vicki, Bragg, Charlotte, Dobelstein, Amy, Gilbert, Stacey, Glasser, Stephen, Hannum, Sara, Hubbell, Anne, Jones, Jennifer, Lee, DeLavallade, Luketic, Ruth, Marshall, Karen, Oden, L. Christie, Raines, Janet, Roche, Cathy, Truman, Janet, Webb, Nita, Wrenn, Audrey, Nathan, David M., Turgeon, Heather, Schumann, Kristina, Cagliero, Enrico, Delahanty, Linda, Hayward, Kathryn, Anderson, Ellen, Bissett, Laurie, Ginsburg, Richard, Goldman, Valerie, Harlan, Virginia, McKitrick, Charles, McNamara, Alan, Michel, Theresa, Poulos, Alexi, Steiner, Barbara, Tosch, Joclyn, Horton, Edward S., Jackson, Sharon D., Hamdy, Osama, Caballero, A. Enrique, Bain, Sarah, Bovaird, Elizabeth, Goebel-Fabbri, Ann, Lambert, Lori, Ledbury, Sarah, Malloy, Maureen, Ovalle, Kerry, Blackburn, George, Mantzoros, Christos, Day, Kristinia, McNamara, Ann, Hill, James O., Miller, Marsha, Phillipp, JoAnn, Schwartz, Robert, Van Dorsten, Brent, Regensteiner, Judith, Benchekroun, Salma, Coelho, Ligia, Cohrs, Paulette, Daeninck, Elizabeth, Fields, Amy, Green, Susan, Hamilton, April, Hamilton, Jere, Leshchinskiy, Eugene, McDermott, Michael, Munkwitz, Lindsey, Rome, Loretta, Wallace, Kristin, Worley, Terra, Foreyt, John P., Reeves, Rebecca S., Pownall, Henry, Balasubramanyam, Ashok, Jones, Peter, Burrington, Michele, Chen, Chu-Huang, Clark, Allyson, Gee, Molly, Griggs, Sharon, Hamilton, Michelle, Holley, Veronica, Joseph, Jayne, Pace, Patricia, Palencia, Julieta, Satterwhite, Olga, Schmidt, Jennifer, Volding, Devin, White, Carolyn, Saad, Mohammed F., Ghazarian, Siran, Chiu, Ken C., Botrous, Medhat, Chan, Michelle, Konersman, Kati, Perpetua, Magpuri, Johnson, Karen C., Gresham, Carolyn, Connelly, Stephanie, Brewer, Amy, Coday, Mace, Jones, Lisa, Lichtermann, Lynne, Vosburg, Shirley, Taylor, J. Lee, Kitabchi, Abbas E., Lambeth, Helen, Clark, Debra, Crisler, Andrea, Cunningham, Gracie, Green, Donna, Force, Debra, Kores, Robert, Rosenthal, Renate, Smith, Elizabeth, Sun, Maria, Soberman, Judith, Jeffery, Robert W., Thorson, Carolyn, Bantle, John P., Redmon, J. Bruce, Crow, Richard S., Crow, Scott, Raatz, Susan K., Brelje, Kerrin, Campbell, Carolyne, Carls, Jeanne, Carmean-Mihm, Tara, Finch, Emily, Fox, Anna, Hoelscher, Elizabeth, James, La Donna, Maddy, Vicki A., Ockenden, Therese, Rice, Birgitta I., Skarphol, Tricia, Tucker, Ann D., Voeller, Mary Susan, Walcheck, Cara, Pi-Sunyer, Xavier, Patricio, Jennifer, Heshka, Stanley, Pal, Carmen, Allen, Lynn, Hirsch, Diane, Holowaty, Mary Anne, Wadden, Thomas A., Maschak-Carey, Barbara J., Schwartz, Stanley, Foster, Gary D., Berkowitz, Robert I., Glick, Henry, Kumanyika, Shiriki K., Brock, Johanna, Chomentowski, Helen, Clark, Vicki, Crerand, Canice, Davenport, Renee, Diamond, Andrea, Fabricatore, Anthony, Hesson, Louise, Krauthamer-Ewing, Stephanie, Kuehnel, Robert, Lipschutz, Patricia, Mullen, Monica, Womble, Leslie, Iqbal, Nayyar, Kelley, David E., Wesche-Thobaben, Jacqueline, Kuller, Lewis, Kriska, Andrea, Bonk, Janet, Danchenko, Rebecca, Edmundowicz, Daniel, Klem, Mary L., Yamamoto, Monica E., Elnyczky, Barb, Grove, George A., Harper, Pat, Krulia, Janet, Mancino, Juliet, Mathews, Anne, Murray, Tracey Y., Ritchea, Joan R., Rush, Jennifer, Vujevich, Karen, Wolf, Donna, Wing, Rena R., Bright, Renee, Pera, Vincent, Jakicic, John, Tate, Deborah, Gorin, Amy, Gallagher, Kara, Bach, Amy, Bancroft, Barbara, Bertorelli, Anna, Carey, Richard, Charron, Tatum, Chenot, Heather, Chula-Maguire, Kimberley, Coward, Pamela, Cronkite, Lisa, Currin, Julie, Daly, Maureen, Egan, Caitlin, Ferguson, Erica, Foss, Linda, Gauvin, Jennifer, Kieffer, Don, Lessard, Lauren, Maier, Deborah, Massaro, J.P., Monk, Tammy, Nicholson, Rob, Patterson, Erin, Phelan, Suzanne, Raynor, Hollie, Raynor, Douglas, Robinson, Natalie, Robles, Deborah, Tavares, Jane, Haffner, Steven M., Montez, Maria G., Lorenzo, Carlos, Kahn, Steven E., Montgomery, Brenda, Knopp, Robert, Lipkin, Edward, Maciejewski, Matthew L., Trence, Dace, Barrett, Terry, Bartell, Joli, Greenberg, Diane, Murillo, Anne, Richmond, Betty Ann, Thomas, April, Knowler, William C., Bolin, Paula, Killean, Tina, Manus, Cathy, Krakoff, Jonathan, Curtis, Jeffrey M., Glass, Justin, Michaels, Sara, Bennett, Peter H., Morgan, Tina, Begay, Shandiin, Fallis, Bernadita, Hermes, Jeanette, Hollowbreast, Diane F., Johnson, Ruby, Meacham, Maria, Nelson, Julie, Percy, Carol, Poorthunder, Patricia, Sangster, Sandra, Scurlock, Nancy, Shovestull, Leigh A., Smiley, Janelia, Toledo, Katie, Tomchee, Christina, Tonemah, Darryl, Peters, Anne, Ruelas, Valerie, Sengardi, Siran Ghazarian, Graves, Kathryn, Serafin-Dokhan, Sara, Espeland, Mark A., Bahnson, Judy L., Wagenknecht, Lynne, Reboussin, David, Rejeski, W. Jack, Bertoni, Alain, Lang, Wei, Miller, Gary, Lefkowitz, David, Reynolds, Patrick S., Ribisl, Paul, Vitolins, Mara, Booth, Michael, Dotson, Kathy M., Hodges, Amelia, Williams, Carrie C., Barnes, Jerry M., Feeney, Patricia A., Griffin, Jason, Harvin, Lea, Herman, William, Hogan, Patricia, Jaramillo, Sarah, King, Mark, Lane, Kathy, Neiberg, Rebecca, Ruggiero, Andrea, Speas, Christian, Walkup, Michael P., Wall, Karen, Ward, Michelle, West, Delia S., Windham, Terri, Nevitt, Michael, Ewing, Susan, Hayashi, Cynthia, Maeda, Jason, Palermo, Lisa, Rahorst, Michaela, Schwartz, Ann, Shepherd, John, Marcovina, Santica M., Strylewicz, Greg, Prineas, Ronald J., Alexander, Teresa, Billings, Lisa, Campbell, Charles, Hall, Sharon, Hensley, Susan, Li, Yabing, Zhang, Zhu-Ming, Mayer-Davis, Elizabeth J., Moran, Robert, Foushee, Richard, Hall, Nancy J., Harrison, Barbara, Hubbard, Van S., Yanovski, Susan Z., Cooper, Lawton S., Cutler, Jeffrey, Obarzanek, Eva, Gregg, Edward W., Williamson, David F., Zhang, Ping, Raynor, Hollie A., Anderson, Andrea M., Miller, Gary D., Reeves, Rebecca, Delahanty, Linda M., Vitolins, Mara Z., Harper, Patricia, Mobley, Connie, and Mayer-Davis, Elizabeth

Published
2015
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24. The Effect of Interventions to Prevent Type 2 Diabetes on the Development of Diabetic Retinopathy: The DPP/DPPOS Experience

Author

White, Neil H., Pan, Qing, Knowler, William C., Schroeder, Emily B., Dabelea, Dana, Chew, Emily Y., Blodi, Barbara, Goldberg, Ronald B., Pi-Sunyer, Xavier, Darwin, Christine, Schlögl, Mathias, Nathan, David M., Goldstein, Barry J., Furlong, Kevin, Smith, Kellie A., Mendoza, Jewel, Wildman, Wendi, Simmons, Marsha, Jensen, Genine, Liberoni, Renee, Spandorfer, John, Pepe, Constance, Donahue, Richard P., Prineas, Ronald, Rowe, Patricia, Giannella, Anna, Calles, Jeanette, Sanguily, Juliet, Cassanova-Romero, Paul, Castillo-Florez, Sumaya, Florez, Hermes J., Garg, Rajesh, Kirby, Lascelles, Lara, Olga, Larreal, Carmen, McLymont, Valerie, Mendez, Jadell, Perry, Arlette, Saab, Patrice, Veciana, Bertha, Haffner, Steven M., Hazuda, Helen P., Montez, Maria G., Isaac, Juan, Hattaway, Kathy, Lorenzo, Carlos, Martinez, Arlene, Salazar, Monica, Walker, Tatiana, Hamman, Richard F., Nash, Patricia V., Steinke, Sheila C., Testaverde, Lisa, Truong, Jennifer, Anderson, Denise R., Ballonoff, Larry B., Bouffard, Alexis, Boxer, Rebecca S., Bucca, Brian, Calonge, B. Ned, Delve, Lynne, Farago, Martha, Hill, James O., Hoyer, Shelley R., Jenkins, Tonya, Jortberg, Bonnie T., Lenz, Dione, Miller, Marsha, Nilan, Thomas, Perreault, Leigh, Price, David W., Regensteiner, Judith G., Seagle, Helen, Smith, Carissa M., VanDorsten, Brent, Horton, Edward S., Munshi, Medha, Lawton, Kathleen E., Poirier, Catherine S., Swift, Kati, Jackson, Sharon D., Arky, Ronald A., Bryant, Marybeth, Burke, Jacqueline P., Caballero, Enrique, Callaphan, Karen M., Fargnoli, Barbara, Franklin, Therese, Ganda, Om P., Guidi, Ashley, Guido, Mathew, Jacobsen, Alan M., Kula, Lyn M., Kocal, Margaret, Lambert, Lori, Ledbury, Sarah, Malloy, Maureen A., Middelbeek, Roeland J.W., Nicosia, Maryanne, Oldmixon, Cathryn F., Pan, Jocelyn, Quitingon, Marizel, Rainville, Riley, Rubtchinsky, Stacy, Seely, Ellen W., Sansoucy, Jessica, Schweizer, Dana, Simonson, Donald, Smith, Fannie, Solomon, Caren G., Spellman, Jeanne, Warram, James, Kahn, Steven E., Montgomery, Brenda K., Fattaleh, Basma, Colegrove, Celeste, Fujimoto, Wilfred, Knopp, Robert H., Lipkin, Edward W., Marr, Michelle, Morgan-Taggart, Ivy, Murillo, Anne, O’Neal, Kayla, Trence, Dace, Taylor, Lonnese, Thomas, April, Tsai, Elaine C., Kitabchi, Abbas E., Dagogo-Jack, Samuel, Murphy, Mary E., Taylor, Laura, Dolgoff, Jennifer, Hampton, Ethel Faye, Applegate, William B., Bryer-Ash, Michael, Clark, Debra, Frieson, Sandra L., Ibebuogu, Uzoma, Imseis, Raed, Lambeth, Helen, Lichtermann, Lynne C., Oktaei, Hooman, Ricks, Harriet, Rutledge, Lily M.K., Sherman, Amy R., Smith, Clara M., Soberman, Judith E., Williamsleaves, Beverly, Patel, Avnisha, Nyenwe, Ebenezer A., Metzger, Boyd E., Molitch, Mark E., Wallia, Amisha, Johnson, Mariana K., VanderMolen, Sarah, Adelman, Daphne T., Behrends, Catherine, Cook, Michelle, Fitzgibbon, Marian, Giles, Mimi M., Hartmuller, Monica, Johnson, Cheryl K.H., Larsen, Diane, Lowe, Anne, Lyman, Megan, McPherson, David, Penn, Samsam C., Pitts, Thomas, Reinhart, Renee, Roston, Susan, Schinleber, Pamela A., McKitrick, Charles, Turgeon, Heather, Larkin, Mary, Mugford, Marielle, Thangthaeng, Nopporn, Leander, Fernelle, Abbott, Kathy, Anderson, Ellen, Bissett, Laurie, Bondi, Kristy, Cagliero, Enrico, Florez, Jose C., Delahanty, Linda, Goldman, Valerie, Grassa, Elaine, Gurry, Lindsey, D’Anna, Kali, Leandre, Fernelle, Lou, Peter, Poulos, Alexandra, Raymond, Elyse, Ripley, Valerie, Stevens, Christine, Tseng, Beverly, Olefsky, Jerrold M., Barrettonnor, Elizabeth, Mudaliar, Sunder, Rosario Araneta, Maria, Carrion-Petersen, Mary Lou, Vejvoda, Karen, Bassiouni, Sarah, Beltran, Madeline, Claravall, Lauren N., Dowden, Jonalle M., Edelman, Steven V., Garimella, Pranav, Henry, Robert R., Horne, Javiva, Lamkin, Marycie, Szerdi Janesch, Simona, Leos, Diana, Polonsky, William, Ruiz, Rosa, Smith, Jean, Torio-Hurley, Jennifer, Pi-Sunyer, F. Xavier, Laferrere, Blandine, Lee, Jane E., Hagamen, Susan, Kelly-Dinham, Kim, Allison, David B., Agharanya, Nnenna, Aronoff, Nancy J., Baldo, Maria, Crandall, Jill P., Foo, Sandra T., Luchsinger, Jose A., Pal, Carmen, Parkes, Kathy, Pena, Mary Beth, Roman, Julie, Rooney, Ellen S., VanWye, Gretchen E.H., Viscovich, Kristine A., Prince, Melvin J., Marrero, David G., Mather, Kieren J., De Groot, Mary, Kelly, Susie M., Jackson, Marcia A., McAtee, Gina, Putenney, Paula, Ackermann, Ronald T., Cantrell, Carolyn M., Dotson, Yolanda F., Fineberg, Edwin S., Fultz, Megan, Guare, John C., Hadden, Angela, Ignaut, James M., Kirkman, Marion S., O’Kelly Phillips, Erin, Pinner, Kisha L., Porter, Beverly D., Roach, Paris J., Rowland, Nancy D., Wheeler, Madelyn L., Ratner, Robert E., Aroda, Vanita, Magee, Michelle, Youssef, Gretchen, Shapiro, Sue, Andon, Natalie, Bavido-Arrage, Catherine, Boggs, Geraldine, Bronsord, Marjorie, Brown, Ernestine, Love Burkott, Holly, Cheatham, Wayman W., Cola, Susan, Evans, Cindy, Gibbs, Peggy, Kellum, Tracy, Leon, Lilia, Lagarda, Milvia, Levatan, Claresa, Lindsay, Milajurine, Nair, Asha K., Park, Jean, Passaro, Maureen, Silverman, Angela, Uwaifo, Gabriel, Wells-Thayer, Debra, Wiggins, Renee, Saad, Mohammed F., Watson, Karol, Budget, Maria, Jinagouda, Sujata, Botrous, Medhat, Sosa, Anthony, Tadros, Sameh, Akbar, Khan, Conzues, Claudia, Magpuri, Perpetua, Ngo, Kathy, Rassam, Amer, Waters, Debra, Xapthalamous, Kathy, Santiago, Julio V., Brown, Angela L., Santiago, Ana, Das, Samia, Khare-Ranade, Prajakta, Stich, Tamara, Fisher, Edwin, Hurt, Emma, Jones, Jackie, Jones, Tracy, Kerr, Michelle, McCowan, Sherri, Ryder, Lucy, Wernimont, Cormarie, Saudek, Christopher D., Hill Golden, Sherita, Bradley, Vanessa, Sullivan, Emily, Whittington, Tracy, Abbas, Caroline, Allen, Adrienne, Brancati, Frederick L., Cappelli, Sharon, Clark, Jeanne M., Charleston, Jeanne B., Freel, Janice, Horak, Katherine, Greene, Alicia, Jiggetts, Dawn, Johnson, Delois, Joseph, Hope, Kalyani, Rita, Loman, Kimberly, Mathioudakis, Nestoras, Maruthur, Nisa, Mosley, Henry, Reusing, John, Rubin, Richard R., Samuels, Alafia, Shields, Thomas, Stephens, Shawne, Stewart, Kerry J., Thomas, LeeLana, Utsey, Evonne, Williamson, Paula, Schade, David S., Adams, Karwyn S., Johannes, Carolyn, Hemphill, Claire, Hyde, Penny, Canady, Janene L., Atler, Leslie F., Boyle, Patrick J., Burge, Mark R., Chai, Lisa, Colleran, Kathleen, Fondino, Ateka, Gonzales, Ysela, Hernandez-McGinnis, Doris A., Katz, Patricia, King, Carolyn, Middendorf, Julia, Rubinchik, Sofya, Senter, Willette, Shamoon, Harry, Crandall, Jill, Brown, Janet O., Trandafirescu, Gilda, Powell, Danielle, Adorno, Elsie, Cox, Liane, Duffy, Helena, Engel, Samuel, Friedler, Allison, Goldstein, Angela, Howardentury, Crystal J., Lukin, Jennifer, Kloiber, Stacey, Longchamp, Nadege, Martinez, Helen, Pompi, Dorothy, Scheindlin, Jonathan, Tomuta, Norica, Violino, Elissa, Walker, Elizabeth A., Wylie-Rosett, Judith, Zimmerman, Elise, Zonszein, Joel, Wing, Rena R., Orchard, Trevor, Venditti, Elizabeth, Koenning, Gaye, Kramer, M. Kaye, Smith, Marie, Jeffries, Susan, Weinzierl, Valarie, Barr, Susan, Benchoff, Catherine, Boraz, Miriam, Clifford, Lisa, Culyba, Rebecca, Frazier, Marlene, Gilligan, Ryan, Guimond, Stephanie, Harrier, Susan, Harris, Louann, Kriska, Andrea, Manjoo, Qurashia, Mullen, Monica, Noel, Alicia, Otto, Amy, Pettigrew, Jessica, Rockette-Wagner, Bonny, Rubinstein, Debra, Semler, Linda, Smith, Cheryl F., Williams, Katherine V., Wilson, Tara, Arakaki, Richard F., Mau, Marjorie K., Latimer, Renee W., Isonaga, Mae K., Baker-Ladao, Narleen K., Bow, Ralph, Bermudez, Nina E., Dias, Lorna, Inouye, Jillian, Melish, John S., Mikami, Kathy, Mohideen, Pharis, Odom, Sharon K., Perry, Raynette U., Yamamoto, Robin E., Hanson, Robert L., Shah, Vallabh, Hoskin, Mary A., Percy, Carol A., Cooeyate, Norman, Natewa, Camille, Dodge, Charlotte, Enote, Alvera, Anderson, Harelda, Acton, Kelly J., Andre, Vickie L., Barber, Rosalyn, Begay, Shandiin, Bennett, Peter H., Benson, Mary Beth, Bird, Evelyn C., Broussard, Brenda A., Bucca, Brian C., Chavez, Marcella, Cook, Sherron, Curtis, Jeff, Dacawyma, Tara, Doughty, Matthew S., Duncan, Roberta, Edgerton, Cyndy, Ghahate, Jacqueline M., Glass, Justin, Glass, Martia, Gohdes, Dorothy, Grant, Wendy, Horse, Ellie, Ingraham, Louise E., Jackson, Merry, Jay, Priscilla, Kaskalla, Roylen S., Kavena, Karen, Kessler, David, Kobus, Kathleen M., Krakoff, Jonathan, Kurland, Jason, Manus, Catherine, McCabe, Cherie, Michaels, Sara, Morgan, Tina, Nashboo, Yolanda, Nelson, Julie A., Poirier, Steven, Polczynski, Evette, Piromalli, Christopher, Reidy, Mike, Roumain, Jeanine, Rowse, Debra, Roy, Robert J., Sangster, Sandra, Sewenemewa, Janet, Smart, Miranda, Spencer, Chelsea, Tonemah, Darryl, Williams, Rachel, Wilson, Charlton, Yazzie, Michelle, Bain, Raymond, Fowler, Sarah, Larsen, Michael D., Jablonski, Kathleen, Temprosa, Marinella, Brenneman, Tina, Edelstein, Sharon L., Abebe, Solome, Bamdad, Julie, Barkalow, Melanie, Bethepu, Joel, Bezabeh, Tsedenia, Bowers, Anna, Butler, Nicole, Callaghan, Jackie, Carter, Caitlin E., Christophi, Costas, Dwyer, Gregory M., Foulkes, Mary, Gao, Yuping, Gooding, Robert, Gottlieb, Adrienne, Grimes, Kristina L., Grover-Fairchild, Nisha, Haffner, Lori, Hoffman, Heather, Jones, Steve, Jones, Tara L., Katz, Richard, Kolinjivadi, Preethy, Lachin, John M., Ma, Yong, Mucik, Pamela, Orlosky, Robert, Reamer, Susan, Rochon, James, Sapozhnikova, Alla, Sherif, Hanna, Stimpson, Charlotte, Hogan Tjaden, Ashley, Walker-Murray, Fredricka, Venditti, Elizabeth M., Kriska, Andrea M., Weinzierl, Valerie, Marcovina, Santica, Aldrich, F. Alan, Harting, Jessica, Albers, John, Strylewicz, Greg, Killeen, Anthony, Gabrielson, Deanna, Eastman, R., Fradkin, Judith, Garfield, Sanford, Lee, Christine, Gregg, Edward, Zhang, Ping, O’Leary, Dan, Evans, Gregory, Budoff, Matthew, Dailing, Chris, Stamm, Elizabeth, Schwartz, Ann, Navy, Caroline, Palermo, Lisa, Rautaharju, Pentti, Prineas, Ronald J., Soliman, Elsayed Z., Alexander, Teresa, Campbell, Charles, Hall, Sharon, Li, Yabing, Mills, Margaret, Pemberton, Nancy, Rautaharju, Farida, Zhang, Zhuming, Hu, Julie, Hensley, Susan, Keasler, Lisa, Taylor, Tonya, Danis, Ronald, Davis, Matthew, Hubbard, Larry, Endres, Ryan, Elsas, Deborah, Johnson, Samantha, Myers, Dawn, Barrett, Nancy, Baumhauer, Heather, Benz, Wendy, Cohn, Holly, Corkery, Ellie, Dohm, Kristi, Domalpally, Amitha, Gama, Vonnie, Goulding, Anne, Ewen, Andy, Hurtenbach, Cynthia, Lawrence, Daniel, McDaniel, Kyle, Pak, Jeong, Reimers, James, Shaw, Ruth, Swift, Maria, Vargo, Pamela, Watson, Sheila, Manly, Jennifer, Mayer-Davis, Elizabeth, Moran, Robert R., Ganiats, Ted, David, Kristin, Sarkin, Andrew J., Groessl, Erik, Katzir, Naomi, Chong, Helen, Herman, William H., Brändle, Michael, Brown, Morton B., Altshuler, David, Billings, Liana K., Chen, Ling, Harden, Maegan, Pollin, Toni I., Shuldiner, Alan R., Franks, Paul W., and Hivert, Marie-France

Subjects
Advanced and Specialized Nursing, Endocrinology, Diabetes and Metabolism, Internal Medicine, Pathophysiology/Complications
Abstract

OBJECTIVE To determine whether interventions that slow or prevent the development of type 2 diabetes in those at risk reduce the subsequent prevalence of diabetic retinopathy. RESEARCH DESIGN AND METHODS The Diabetes Prevention Program (DPP) randomized subjects at risk for developing type 2 diabetes because of overweight/obesity and dysglycemia to metformin (MET), intensive lifestyle intervention (ILS), or placebo (PLB) to assess the prevention of diabetes. During the DPP and DPP Outcome Study (DPPOS), we performed fundus photography over time on study participants, regardless of their diabetes status. Fundus photographs were graded using the Early Treatment Diabetic Retinopathy Study grading system, with diabetic retinopathy defined as typical lesions of diabetic retinopathy (microaneurysms, exudates, or hemorrhage, or worse) in either eye. RESULTS Despite reduced progression to diabetes in the ILS and MET groups compared with PLB, there was no difference in the prevalence of diabetic retinopathy between treatment groups after 1, 5, 11, or 16 years of follow-up. No treatment group differences in retinopathy were found within prespecified subgroups (baseline age, sex, race/ethnicity, baseline BMI). In addition, there was no difference in the prevalence of diabetic retinopathy between those exposed to metformin and those not exposed to metformin, regardless of treatment group assignment. CONCLUSIONS Interventions that delay or prevent the onset of type 2 diabetes in overweight/obese subjects with dysglycemia who are at risk for diabetes do not reduce the development of diabetic retinopathy for up to 20 years.

Published
2022
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33. Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: a Joint Statement by International Diabetes Organizations

Author

Rubino, Francesco, Nathan, David M., Eckel, Robert H., Schauer, Philip R., Alberti, K. George M. M., Zimmet, Paul Z., Del Prato, Stefano, Ji, Linong, Sadikot, Shaukat M., Herman, William H., Amiel, Stephanie A., Kaplan, Lee M., Taroncher-Oldenburg, Gaspar, Cummings, David E., and on behalf of the Delegates of the 2nd Diabetes Surgery Summit

Published
2017
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34. Eulogy for the clinical research center

Author

Nathan, David G. and Nathan, David M.

Subjects
Clinical research organizations -- History -- Appreciation, Health care industry
Abstract

The extramural General Clinical Research Center (GCRC) program has been funded for more than 50 years, first by the National Center for Research Resources, NIH, and more recently as part of the Clinical Translational Science Award (CTSA) program through the newly formed National Center for Advancing Translation Sciences (NCATS). The GCRCs represent the federally funded laboratories that employ a highly trained cadre of research nurses, dietitians, and other support staff and in which generations of clinical investigators trained and performed groundbreaking human studies that advanced medical science and improved clinical care. Without the opportunity for adequate discussion, NCATS has now stopped funding these Research Centers. In this 'eulogy,' we review the origins and history of the GCRCs, their contributions to the advancement of medicine, and the recent events that have essentially defunded them. We mourn their loss., Introduction The Clinical Research Center (CRC) program, supported by NIH extramural funding, is now dead (1). The CRCs included the only federally supported beds (~600 nationwide) and outpatient human research [...]

Published
2016

35. Risk factors for the development of retinopathy in pre-diabetes and type 2 diabetes: The Diabetes Prevention Program experience

Author

White, Neil H, Pan, Qing, Knowler, William C, Schroeder, Emily B, Dabelea, Dana, Chew, Emily Y, Blodi, Barbara, Goldberg, Ronald B, Pi-Sunyer, Xavier, Darwin, Christine, Schlögl, Mathias, Nathan, David M, et al, and University of Zurich

Subjects
Advanced and Specialized Nursing, Diabetes and Metabolism, Endocrinology, 11221 Clinic for Geriatric Medicine, Internal Medicine, 610 Medicine & health
Abstract

OBJECTIVE: To determine glycemic and non-glycemic risk factors that contribute to the presence of diabetic retinopathy (DR) before and after the onset of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: During the Diabetes Prevention Program (DPP) and DPP Outcome Study (DPPOS), we performed fundus photography over time on adults at high risk to develop T2D, including after they developed diabetes. Fundus photographs were graded using the ETDRS grading system with DR defined as typical lesions of DR (microaneurysms, exudates or hemorrhage, or worse) in either eye. RESULTS: By DPPOS year 16 (approximately 20 years after randomization into DPP), 24% of 1,614 who had developed T2D and 14% of 885 who remained non-diabetic had DR. In univariate analyses, utilizing results from across the entire duration of follow-up, American Indian race was associated with less frequent DR compared to Non-Hispanic Whites (NHW), and higher HbA1c, fasting and 2-hour plasma glucose levels during an oral glucose tolerance test, weight, and history of hypertension, dyslipidemia and smoking, but not treatment group assignment, were associated with more frequent DR. On multivariate analysis, American Indian race was associated with less DR compared to NHW (OR = 0.36; 95% CI: 0.20-0.66) and average HbA1c was associated with more DR (OR = 1.92; 95% CI: 1.46-1.74 per SD [0.7%] increase in HbA1c). CONCLUSION: DR may occur in adults with prediabetes and early in the course of T2D. HbA1c was an important risk factor for the development of DR across the entire glycemic range from prediabetes to T2D.

Published
2022
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36. Risk factors for the development of retinopathy in pre-diabetes and type 2 diabetes: The Diabetes Prevention Program experience

Author

White, Neil H., primary, Pan, Qing, primary, Knowler, William C., primary, Schroeder, Emily B., primary, Dabelea, Dana, primary, Chew, Emily Y., primary, Blodi, Barbara, primary, Goldberg, Ronald B., primary, Pi-Sunyer, Xavier, primary, Darwin, Christine, primary, Schlögl, Mathias, primary, Nathan, David M., primary, and Group, the DPPOS Research, primary

Published
2022
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41. The Effect of Interventions to Prevent Type 2 Diabetes on the Development of Diabetic Retinopathy: The DPP/DPPOS Experience

Author

White, Neil H., primary, Pan, Qing, primary, Knowler, William C., primary, Schroeder, Emily B., primary, Dabelea, Dana, primary, Chew, Emily Y., primary, Blodi, Barbara, primary, Goldberg, Ronald B., primary, Pi-Sunyer, Xavier, primary, Darwin, Christine, primary, Schlögl, Mathias, primary, Nathan, David M., primary, and Group, the Diabetes Prevention Program Research, primary

Published
2022
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43. Association of Traumatic Brain Injury With the Risk of Developing Chronic Cardiovascular, Endocrine, Neurological, and Psychiatric Disorders

Author

Izzy, Saef, primary, Chen, Patrick M., additional, Tahir, Zabreen, additional, Grashow, Rachel, additional, Radmanesh, Farid, additional, Cote, David J., additional, Yahya, Taha, additional, Dhand, Amar, additional, Taylor, Herman, additional, Shih, Shirley L., additional, Albastaki, Omar, additional, Rovito, Craig, additional, Snider, Samuel B., additional, Whalen, Michael, additional, Nathan, David M., additional, Miller, Karen K., additional, Speizer, Frank E., additional, Baggish, Aaron, additional, Weisskopf, Marc G., additional, and Zafonte, Ross, additional

Published
2022
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44. Weight Change During the Postintervention Follow-up of Look AHEAD

Author

Wing, Rena R., primary, Neiberg, Rebecca H., additional, Bahnson, Judy L., additional, Clark, Jeanne M., additional, Espeland, Mark A., additional, Hill, James O., additional, Johnson, Karen C., additional, Knowler, William C., additional, Olson, KayLoni, additional, Steinburg, Helmut, additional, Pi-Sunyer, Xavier, additional, Wadden, Thomas A., additional, Wyatt, Holly, additional, Swartz, Lee, additional, Jiggetts, Dawn, additional, Charleston, Jeanne, additional, Cheskin, Lawrence, additional, Maruthur, Nisa M., additional, Pilla, Scott J., additional, Diggins, Danielle, additional, Johnson, Mia, additional, Bray, George A., additional, Greenway, Frank L., additional, Ryan, Donna H., additional, Champagne, Catherine, additional, Myers, Valerie, additional, Keller, Jeffrey, additional, Stewart, Tiffany, additional, Arceneaux, Jennifer, additional, Boley, Karen, additional, Fry, Greta, additional, Jones, Lisa, additional, Landry, Kim, additional, Lingle, Melissa, additional, Smith, Marisa, additional, Lewis, Cora E., additional, Thomas, Sheikilya, additional, Glasser, Stephen, additional, Dutton, Gareth, additional, Dobelstein, Amy, additional, Hannum, Sara, additional, Hubbell, Anne, additional, Lee, DeLavallade, additional, Millhouse, Phyllis, additional, Oden, L. Christie, additional, Roche, Cathy, additional, Grant, Jackie, additional, Turman, Janet, additional, Nathan, David M., additional, Goldman, Valerie, additional, Delahanty, Linda, additional, Larkin, Mary, additional, Dalton, Kristen, additional, Singh, Roshni, additional, Ruazol, Melanie, additional, Munshi, Medha N., additional, Jackson, Sharon D., additional, Middelbeek, Roeland J.W., additional, Caballero, A. Enrique, additional, Rodriguez, Anthony, additional, Blackburn, George, additional, Mantzoros, Christos, additional, McNamara, Ann, additional, Breen, Jeanne Anne, additional, Miller, Marsha, additional, Bochert, Debbie, additional, Bossart, Suzette, additional, Cohrs, Paulette, additional, Green, Susan, additional, Hamilton, April, additional, Leshchinskiy, Eugene, additional, Rome, Loretta, additional, Foreyt, John P., additional, Gee, Molly, additional, Pownall, Henry, additional, Balasubramanyam, Ashok, additional, Chen, Chu-Huang, additional, Jones, Peter, additional, Burrington, Michele, additional, Gardner, Allyson Clark, additional, Griggs, Sharon, additional, Hamilton, Michelle, additional, Holley, Veronica, additional, Lee, Sarah, additional, Liscum, Sarah Lane, additional, Cantu-Lumbreras, Susan, additional, Palencia, Julieta, additional, Schmidt, Jennifer, additional, Thomas, Jayne, additional, White, Carolyn, additional, Wright, Charlyne, additional, Alvarez, Monica, additional, Griffin, Beate, additional, Coday, Mace, additional, Valenski, Donna, additional, Johnson, Karen, additional, Jeffery, Robert W., additional, Skarphol, Tricia, additional, Bantle, John P., additional, Redmon, J. Bruce, additional, Brelje, Kerrin, additional, Campbell, Carolyne, additional, Forseth, Mary Ann, additional, Uccellini, Soni, additional, Voeller, Mary Susan, additional, Laferrère, Blandine, additional, Patricio, Jennifer, additional, Luchsinger, Jose, additional, Palta, Priya, additional, Lyon, Sarah, additional, Kelly, Kim, additional, Maschak-Carey, Barbara J., additional, Berkowitz, Robert I., additional, Chao, Ariana, additional, Davenport, Renee, additional, Gruber, Katherine, additional, Leonard, Sharon, additional, Walsh, Olivia, additional, Jakicic, John M., additional, Wesche-Thobaben, Jacqueline, additional, Ewing, Lin, additional, Hergenroeder, Andrea, additional, Korytkowski, Mary, additional, Copelli, Susan, additional, Danchenko, Rebecca, additional, Ives, Diane, additional, Mancino, Juliet, additional, Martich, Lisa, additional, McGuire, Meghan, additional, Murray, Tracey Y., additional, Semler, Linda, additional, Williams, Kathy, additional, Wing, Rena R., additional, Egan, Caitlin, additional, Jelalian, Elissa, additional, McCaffery, Jeanne, additional, McDermott, Kathryn Demos, additional, Unick, Jessica, additional, Annis, Kirsten, additional, DaCruz, Jose, additional, Rafanelli, Ariana, additional, Hazuda, Helen P., additional, Isaac, Juan Carlos, additional, Hernandez, Prepedigna, additional, Kahn, Steven E., additional, Boyko, Edward J., additional, Tsai, Elaine, additional, Wright, Lorena, additional, Atkinson, Karen, additional, Morgan-Taggart, Ivy, additional, Socha, Jolanta, additional, Urquhart, Heidi, additional, Bolin, Paula, additional, Anderson, Harelda, additional, Michaels, Sara, additional, Johnson, Ruby, additional, Poorthunder, Patricia, additional, Smiley, Janelia, additional, Peters, Anne L., additional, Ghazarian, Siran, additional, Beale, Elizabeth, additional, Ramirez, Edgar, additional, Rodriguez, Gabriela, additional, Ruelas, Valerie, additional, Serafin-Dokhan, Sara, additional, Walker, Martha, additional, Perez, Marina, additional, Wagenknecht, Lynne E., additional, Reboussin, David, additional, Miller, Mike E., additional, Brubaker, Peter, additional, Pajewski, Nicholas, additional, Bancks, Michael, additional, Ding, Jingzhong, additional, Deep, Gagan, additional, Hayden, Kathleen, additional, Rapp, Stephen R., additional, Simpson, Felicia, additional, Chen, Haiying, additional, Sachs, Bonnie C., additional, Houston, Denise, additional, Chen, Shyh-Huei, additional, Anderson, Andrea, additional, Barnes, Jerry M., additional, Barr, Mary, additional, Beckner, Tara D., additional, Cook, Delilah R., additional, Williams, Carrie C., additional, Evans, Joni, additional, Garcia, Katie, additional, Gaussoin, Sarah A., additional, Kittel, Carol, additional, Harvin, Lea, additional, Howard, Marjorie, additional, Lovato, James, additional, Pierce, June, additional, Steinberg, Debbie, additional, Webb, Christopher, additional, Walker, Jennifer, additional, Walkup, Michael P., additional, Watkins, Carolyn, additional, Marcovina, Santica M., additional, Hurting, Jessica, additional, Albers, John J., additional, Gaur, Vinod, additional, Nevitt, Michael, additional, Schwartz, Ann, additional, Shepherd, John, additional, Rahorst, Michaela, additional, Palermo, Lisa, additional, Ewing, Susan, additional, Hayashi, Cynthia, additional, and Maeda, Jason, additional

Published
2022
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45. Association Between Change in Accelerometer-Measured and Self-Reported Physical Activity and Cardiovascular Disease in the Look AHEAD Trial

Author

Jakicic, John M., primary, Berkowitz, Robert I., primary, Bolin, Paula, primary, Bray, George A., primary, Clark, Jeanne M., primary, Coday, Mace, primary, Egan, Caitlin, primary, Evans, Mary, primary, Foreyt, John P., primary, Fulton, Janet E., primary, Greenway, Frank L., primary, Gregg, Edward W., primary, Hazuda, Helen P., primary, Hill, James O., primary, Horton, Edward S., primary, Hubbard, Van S., primary, Jeffery, Robert W., primary, Johnson, Karen C., primary, Johnson, Ruby, primary, Kahn, Steven E., primary, Kure, Anne, primary, Lang, Wei, primary, Lewis, Cora E., primary, Nathan, David M., primary, Patricio, Jennifer, primary, Peters, Anne, primary, Pi-Sunyer, Xavier, primary, Pownall, Henry, primary, Rejeski, W. Jack, primary, Safford, Monika, primary, Stewart, Kerry J., primary, Wadden, Thomas A., primary, Walkup, Michael P., primary, Wing, Rena R., primary, and Wyatt, Holly, primary

Published
2022
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46. Erratum. Rationale and Design of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). Diabetes Care 2013;36:2254–2261

Author

Nathan, David M., Buse, John B., Kahn, Steven E., Krause-Steinrauf, Heidi, Larkin, Mary E., Staten, Myrlene, Wexler, Deborah, and Lachin, John M.

Subjects
Adult, Blood Glucose, Glycated Hemoglobin, Male, Comparative Effectiveness Research, Dipeptidyl-Peptidase IV Inhibitors, Cost-Benefit Analysis, Sitagliptin Phosphate, Insulin Glargine, Liraglutide, Middle Aged, Triazoles, Metformin, Insulin, Long-Acting, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Glucagon-Like Peptide 1, Pyrazines, Outcome Assessment, Health Care, Humans, Hypoglycemic Agents, Female, Erratum
Abstract

The epidemic of type 2 diabetes (T2DM) threatens to become the major public health problem of this century. However, a comprehensive comparison of the long-term effects of medications to treat T2DM has not been conducted. GRADE, a pragmatic, unmasked clinical trial, aims to compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes.GRADE was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The consensus protocol was approved by NIDDK and the GRADE Research Group. Eligibility criteria for the 5,000 metformin-treated subjects include5 years' diabetes duration, ≥ 30 years of age at time of diagnosis, and baseline hemoglobin A1c (A1C) of 6.8-8.5% (51-69 mmol/mol). Medications representing four classes (sulfonylureas, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 receptor agonists, and insulin) will be randomly assigned and added to metformin (minimum-maximum 1,000-2,000 mg/day). The primary metabolic outcome is the time to primary failure defined as an A1C ≥ 7% (53 mmol/mol), subsequently confirmed, over an anticipated mean observation period of 4.8 years (range 4-7 years). Other long-term metabolic outcomes include the need for the addition of basal insulin after a confirmed A1C7.5% (58 mmol/mol) and, ultimately, the need to implement an intensive basal/bolus insulin regimen. The four drugs will also be compared with respect to selected microvascular complications, cardiovascular disease risk factors, adverse effects, tolerability, quality of life, and cost-effectiveness.GRADE will compare the long-term effectiveness of major glycemia-lowering medications and provide guidance to clinicians about the most appropriate medications to treat T2DM. GRADE begins recruitment at 37 centers in the U.S. in 2013.

Published
2022

47. 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

50. Screening for Diabetes Mellitus

Author

Singer, Daniel E., Samet, Jeffrey H., Coley, Christopher M., Nathan, David M., Lipkin, Mack, Jr., editor, Goldbloom, Richard B., editor, and Lawrence, Robert S., editor

Published
1990
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