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Clinical Trial
. 2025 Jul;68(7):1403-1415.
doi: 10.1007/s00125-025-06369-8. Epub 2025 Feb 14.

Differential associations of somatic and cognitive-affective symptoms of depression with inflammation and insulin resistance: cross-sectional and longitudinal results from the Emotional Distress Sub-Study of the GRADE study

Dominic Ehrmann  1   2 , Heidi Krause-Steinrauf  3 , Diane Uschner  3 , Hui Wen  3 , Claire J Hoogendoorn  4   5 , Gladys Crespo-Ramos  5 , Caroline Presley  6 , Valerie L Arends  7 , Robert M Cohen  8 , W Timothy Garvey  9 , Thomas Martens  10 , Holly J Willis  10 , Andrea Cherrington  6 , Jeffrey S Gonzalez  4   5   11   12 ; GRADE Research Group
Collaborators, Affiliations
Clinical Trial

Differential associations of somatic and cognitive-affective symptoms of depression with inflammation and insulin resistance: cross-sectional and longitudinal results from the Emotional Distress Sub-Study of the GRADE study

Dominic Ehrmann et al. Diabetologia. 2025 Jul.

Erratum in

Abstract

Aims/hypothesis: Insulin resistance and inflammation are components of a biological framework that is hypothesised to be shared by type 2 diabetes and depression. However, depressive symptoms include a large heterogeneity of somatic and cognitive-affective symptoms, and this may obscure the associations within this biological framework. Cross-sectional and longitudinal data were used to disentangle the contributions of insulin resistance and inflammation to somatic and cognitive-affective symptoms of depression.

Methods: This secondary analysis used data from the Emotional Distress Sub-Study of the GRADE trial. Insulin resistance and inflammation were assessed using the HOMA-IR estimation and high-sensitivity C-reactive protein (hsCRP) levels, respectively, at baseline and at the study visits at year 1 and year 3 (HOMA-IR) and every 6 months (hsCRP) for up to 3 years of follow-up. Depressive symptoms were assessed at baseline using the Patient Health Questionnaire (PHQ-8), and a total score as well as symptom cluster scores for cognitive-affective and somatic symptoms were calculated. For the cross-sectional analyses, linear regression analyses were performed, with inflammation and insulin resistance at baseline as dependent variables. For the longitudinal analyses, linear mixed-effect regression analyses were performed, with inflammation and insulin resistance at the various time points as dependent variables. In all analyses, depressive symptoms (total score and symptom cluster scores) were the independent variables, controlled for important demographic, anthropometric and metabolic confounders. For the analysis of insulin resistance (HOMA-IR), data from 1321 participants were analysed. For the analysis of inflammation (hsCRP), data from 1739 participants were analysed.

Results: In cross-sectional analysis and after adjustment for potential confounders, a one-unit increase in PHQ-8 total score was significantly associated with a 0.8% increase in HOMA-IR (p=0.007), but not with hsCRP (0.6% increase, p=0.283). The somatic symptom score was associated with a 5.8% increase in HOMA-IR (p=0.004). Single-item analyses of depressive symptoms showed that fatigue (3.6% increase, p=0.002) and increased/decreased appetite (3.5% increase, p=0.009) were significantly associated with HOMA-IR cross-sectionally. The cognitive-affective symptom score was not significantly associated with HOMA-IR at baseline. In longitudinal analyses, a one-unit increase in PHQ-8 total score was significantly associated with a 0.8% increase in hsCRP over time (p=0.014), but not with HOMA-IR over time (0.1% decrease, p=0.564). Again, only the somatic symptom cluster was significantly associated with hsCRP over time (5.2% increase, p=0.017), while the cognitive-affective symptom score was not.

Conclusion/interpretation: The results highlight the associations of depressive symptoms with markers of inflammation and insulin resistance, both cross-sectionally and longitudinally, in individuals with type 2 diabetes. In particular, somatic symptoms of depression appear to be the driver of these associations, even after controlling for concomitant conditions, with a potential role for fatigue and issues with appetite.

Trial registration: ClinicalTrials.gov NCT01794143.

Keywords: Depression; Inflammation; Insulin resistance; Somatic symptoms; Type 2 diabetes.

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Conflict of interest statement

Acknowledgements: The following GRADE Research Group investigators were collaborators in this work: GRADE Emotional Distress Substudy Research Group (April 30, 2021) Designations: Principal Investigator (PI); Co-Principal Investigator (Co-PI); Co-Investigator (Co-I); Study Coordinator (SC); Recruitment/Retention Coordinator (RC); Research Staff (RS) Co-Principal Investigators of the Emotional Distress Substudy: Cherrington, AL (Co-Chair, University of Alabama Birmingham, Birmingham, AL, USA); Gonzalez, Jeffrey S. (Co-Chair, Yeshiva University, Bronx, NY, USA; Albert Einstein College of Medicine Bronx, NY, USA);Krause-Steinrauf, H (Coordinating Center, The George Washington University Biostatistics Center, Rockville, MD, USA) Current Clinical Centers Albert Einstein College of Medicine, Bronx, New York, USA: Crandall, JP (PI); McKee, MD (Co-PI, past); Behringer-Massera, S (Co-I, past); Brown-Friday, J (SC); Xhori, E (RC, past); Ballentine-Cargill, K (RS); Duran, S (RS); Estrella, H (RS); Gonzalez de la torre, S (RS, past); Lukin, J (RS, past) Atlanta VA Medical Center, Decatur, GA, USA: Phillips, LS (PI); Burgess, E (Co-I); Olson, D (Co-I); Rhee, M (Co-I); Wilson, P (Co-I); Raines, TS (SC); Boers, J (SC); Costello, J (SC); Maher-Albertelli, M (SC); Mungara, R (SC); Savoye, L (SC, past); White, CA (SC); Gullett, C (SC; past); Holloway, L (SC, past); Morehead, F (SC, past); Person, S (SC, past); Sibymon, M (SC, past); Tanukonda, S (SC, past); Adams, C (RC, past); Ross, A (RC, past) Baylor College of Medicine, Houston, Texas, USA: Balasubramanyam, A (PI); Gaba, R (Co-I); Gonzalez Hattery, E (SC); Ideozu, A (SC); Jimenez, J (SC); Montes, G (RC); Wright, C (RS, past) Case Western Reserve University/Cleveland VA/MetroHealth Medical Center, Cleveland, OH, USA: Ismail-Beigi, F (PI); Falck-Ytter, C (Co-PI); Sayyed Kassem, L (Co-PI); Sood, A (Co-PI, past); Tiktin, M (Co-I, SC); Kulow, T (SC); Newman, C (SC); Stancil, KA (SC); Cramer, B (SC, past); Iacoboni, J (SC, past); Kononets, MV (SC, past); Sanders, C (SC, past); Tucker, L (SC, past); Werner, A (SC, past); Maxwell, A (RS); McPhee, G (RS); Patel, C (RS); Colosimo, L (RS, past); Krol, A (RS, past) Columbia University Medical Center, New York, NY, USA: Goland, R (PI); Pring, J (SC); Alfano, L (SC); Kringas, P (SC, past); Hausheer, C (RC, past); Tejada, J (RC, past); Gumpel, K (RS, past); Kirpitch, A (RS, past); Schneier, H (RS, past) Indiana University, Bloomington, IN, USA: Mariash, CN (PI); Mather, KJ (PI, past); Ismail, HM (Co-I); Lteif, A (Co-I, past); Mullen, M (SC); Hamilton, T (SC, past); Patel, N (SC, past); Riera, G (RC); Jackson, M (RC, past); Pirics, V (RC, past); Aguillar, D (RS, past); Howard, D (RS, past); Hurt, S (RS, past) International Diabetes Center, Minneapolis, MN, USA: Bergenstal, R (PI); Carlson, A (Co-I); Martens, T (Co-I); Johnson, M (SC); Hill, R (SC); Hyatt, J (SC); Jensen, C (SC); Madden, M (SC); Martin, D (SC); Willis, H (SC); Konerza, W (RS); Yang, S (RS); Kleeberger, K (RS, past); Passi, R (RS, past) Kaiser Permanente Northwest, Portland, OR, USA: Fortmann, S (PI); Herson, M (Co-I); Mularski, K (Co-I); Glauber, H (Co-I, past); Prihoda, J (Co-I, past); Ash, B (SC); Carlson, C (SC); Ramey, PA (SC); Schield, E (SC); Torgrimson-Ojerio, B (SC); Arnold, K (SC, past); Kauffman, B (SC, past); Panos, E (SC, past); Sahnow, S (RC); Bays, K (RS); Berame, K (RS); Cook, J (RS); Ghioni, D (RS); Gluth, J (RS); Schell, K (RS); Criscola, J (RS, past); Friason, C (RS, past); Jones, S (RS, past); Nazarov, S (RS, past) Massachusetts General Hospital, Boston, MA, USA: Wexler, D (PI); Larkin, ME (Co-I, SC); Meigs, J (Co-I); Chambers, B (SC, past); Dushkin, A (SC, past); Rocchio, G (SC, past); Yepes, M (SC, past); Steiner, B (RC); Dulin, H (RC, past); Cayford, M (RS); Chu, K (RS); DeManbey, A (RS); Hillard, M (RS); Martin, K (RS); Thangthaeng, N (RS); Gurry, L (RS, past); Kochis, R (RS, past); Raymond, E (RS, past); Ripley, V (RS, past); Stevens, C (RS, past) MedStar Health Research Institute/ MedStar Baltimore, Hyattsville, MD, USA: Park, J (PI); Aroda, V (PI, past); Ghazi, A (Co-PI); Magee, M (Co-I); Ressing, Ann (Co-I); Loveland, A (SC); Hamm, M (SC); Hurtado, M (SC); Kuhn, A (SC); Leger, J (SC); Manandhar, L (SC); Mwicigi, F (SC); Sanchez, O (SC); Young, T (SC) Miami VA Healthcare System/University of Miami, Miami, FL, USA: Garg, R (PI), Lagari-Libhaber, V (PI); Florez, HJ (PI, past); Valencia, WM (PI, past); Marks, J (Co-PI, past); Casula, S (Co-I); Oropesa-Gonzalez, L (SC); Hue, L (SC, past); Cuadot, A (SC, past); Nieto-Martinez, R (SC, past); Riccio Veliz, AK (SC, past); Gutt, M (RC, past); Kendal, YJ (RS, past); Veciana, B. (RS, past) Pacific Health Research and Education Institute/VA Pacific Islands, Honolulu, HI, USA: Hox, SH (PI); Petrovitch, H (Co-PI); Matwichyna, M (SC); Jenkins, V (SC, past); Broadwater, L (RS); Ishii, RR (RS); Bermudez, NO (RS; past) Pennington Biomedical Research Center, Baton Rouge, LA, USA: Hsia, DS (PI); Cefalu, WT (PI, past); Greenway, FL (Co-I); Waguespack, C (Co-I); King, E (SC); Fry, G (SC); Dragg, A (SC); Gildersleeve, B (SC); Arceneaux, J (SC); Haynes, N (SC, past); Thomassie, A (SC, past); Pavlionis, M (SC, past); Bourgeois, B (RC, past); Hazlett, C (RS) Southwestern American Indian Center, Phoenix, AZ, USA: Krakoff, J (PI); Curtis, JM (Co-I); Killean, T (SC); Khalid, M (SC); Joshevama, E (RC, past); Diaz, E (RS); Martin, D (RS); Tsingine, K (RS); Karshner, T (RS, past) SUNY Downstate Medical Center/New York Hospital‐Queens, Brooklyn, NY, USA: Banerji, MA (PI); August, P (Co-I); Lee, M (Co-I); Lorber, D (Co-I); Brown, NM (SC, RC); Josephson, DH (SC); Thomas, LL (SC, RC); Tsovian, M (SC, RC); Cherian, A (SC, RC, past); Jacobson, MH (RS); Mishko, MM (RS) University of Alabama Birmingham, Birmingham, AL, USA: Garvey, WT (PI); Dyer, D (SC); Lawson, MCR (SC); Griffith, O (SC, past); Agne, A (RC); McCullars, S (RC) University of Cincinnati/Cincinnati VA Medical Center, Cincinnati OH, USA: Cohen, RM (PI); Craig, J (SC); Rogge, MC (SC; past); Burton, K (SC, past); Kersey, K (SC, RC, past); Wilson, C (SC, past); Lipp, S (RC, past); Vonder Meulen, MB (RC, past); Adkins, C (RS); Onadeko, T (RS) University of Colorado‐Denver/VA, Aurora, CO, USA: Rasouli, N (PI); Baker, C (Co-I); Schroeder, E (Co-I, past); Razzaghi, M (Co-I); Lyon, C (Co-I, past); Penaloza, R (Co-I, past); Underkofler, C (SC); Lorch, R (SC); Douglass, S (SC, past); Steiner, S (SC, past) University of Iowa, Iowa City, IA, USA: Sivitz, WI (PI); Cline, E (SC); Knosp, LK (SC); McConnell, J (SC, past); Lowe, T (RC) University of Michigan, Ann Arbor, MI, USA: Herman, WH (PI); Pop-Busui, R (Co-PI); Tan, MH (Co-I); Martin, C (SC); Waltje, A (SC, RC); Katona, A (SC); Goodhall, L (SC, past); Eggleston, R (RC, past); Kuo, S (RS); Bojescu, S (RS, past); Bule, S (RS, past); Kessler, N (RS, past); LaSalle, E (RS, past); Whitley, K (RS, past) University of Minnesota, Minneapolis, MN, USA: Seaquist, ER (PI); Bantle, A (Co-I); Harindhanavudhi, T (Co-I); Kumar, A (Co-I); Redmon, B (Co-I); Bantle, J (Co-I, past); Coe, M (SC); Mech, M (SC); Taddese, A (RC); Lesne, L (RS); Smith, S (RS) University of Nebraska Medical Center/Omaha VA, Omaha, NE, USA: Desouza, C (PI); Kuechenmeister, L (Co-I); Shivaswamy, V (Co-I); Burbach, S (SC); Rodriguez, MG (SC); Seipel, K (SC); Alfred, A (SC, past); Morales, AL (SC; past); Eggert, J (RS); Lord, G (RS); Taylor, W (RS, past); Tillson, R (RS, past) University of New Mexico, Albuquerque, NM, USA: Schade, DS (PI); Adolphe, A (Co-PI); Burge, M (Co-PI, past); Duran-Valdez, E (SC); Martinez, J (RC, past); Bancroft, A (RS); Kunkel, S (RS); Ali Jamaleddin Ahmad, F (RS, past); Hernandez McGinnis, D (RS, past); Pucchetti, B (RS, past); Scripsick, E (RS, past); Zamorano, A (RS, past) University of Texas‐Southwestern Medical Center, Dallas, TX, USA: Raskin, P (PI); Rhee, C (Co-I, past); Abraham, S (SC); Jordan, LF (SC); Sao, S (SC); Morton, L (SC, past); Smith, O (SC, past); Osornio Walker, L (RC, past); Schnurr-Breen, L (RC, past); Ayala, R (RS); Kreymer, RB (RS); Sturgess, D (RS, past) VA Puget Sound Health Care System/University of Washington, Seattle, WA, USA: Utzschneider, KM (PI); Kahn, SE (Co-I); Alarcon-Casas Wright, L (Co-I); Boyko, EJ (Co-I); Tsai, EC (Co-I); Trence, DL (Co-I, past); Trikudanathan, S (Co-I, past); Fattaleh, BN (SC); Montgomery, BK (SC, past); Atkinson, KM (RS); Kozedub, A (RS); Concepcion, T (RS, past); Moak, C (RS, past); Prikhodko, N (RS, past); Rhothisen, S (RS, past) Yale University/Fair Haven Community Health Center/West Haven VA Medical Center, New Haven, CT, USA: Tamborlane, W (PI); Camp, A (Co-I); Gulanski, B (Co-I); Inzucchi, SE (Co-I); Pham, K (Co-I); Alguard, M (SC, RC); Gatcomb, P (SC); Lessard, K (SC); Perez, M (SC); Iannone, L (RC);Magenheimer, E (RC); Montosa, A (RC) Study Units NIH/NIDDK (Sponsor), Rockville, MD, USA: Cefalu, WT (Director, Division of Diabetes, Endocrinology and Metabolic Diseases);Fradkin, J (Director, Division of Diabetes, Endocrinology and Metabolic Diseases, past); Burch, HB (Project Scientist); Bremer, AA (Project Scientist, past) Chairman’s Office, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA: Nathan, DM (Study Chair, Study Co-PI) Executive Committee: Nathan, DM (Study Chair, Study Co-PI, Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, MA, USA); Lachin, JM (U01 Contact PI, Study Co-PI, The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA); Buse, JB (Co-I, The University of North Carolina School of Medicine, Chapel Hill, NC, USA); Kahn, SE (Co-I, Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA); Krause-Steinrauf, H (Co-I, Project Director, The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA); Larkin, ME (Co-I, SC, Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, MA, USA); Tiktin, M (Co-I, SC, Case Western Reserve University, Cleveland, OH); Wexler, D (PI, Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, MA, USA); Burch, HB (Program Scientist, National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Rockville, MD, USA); Bremer, AA (Project Scientist, past, National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Rockville, MD, USA) Coordinating Center, The George Washington University Biostatistics Center, Rockville, MD, USA: Lachin, JM (U01 Contact PI, Study Co-PI); Younes, N (Co-I); Bebu, I (RS); Butera, N (RS); Buys, CJ (RS); Fagan, A (RS); Gao, Y (RS); Ghosh, A (RS); Gramzinski, MR (RS); Hall, SD (RS); Kazemi, E (RS); Legowski, E (RS); Liu, H (RS); Suratt, C (RS); Tripputi, M (RS); Arey, A (RS, past); Backman, M (RS, past); Bethepu, J (RS, past); Lund, C (RS, past); Mangat Dhaliwal, P (RS, past); McGee, P (RS, past); Mesimer, E (RS, past); Ngo, L (RS, past) Central Biochemical Laboratory, University of Minnesota Advanced Research and Diagnostic Laboratory, Minneapolis, MN, USA: Steffes, M (PI); Seegmiller, J (Co-I); Saenger, A (Co-I, past); Arends, V (SC); Gabrielson, D (SC, past) Drug Distribution Center, VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA: Conner, T (PI); Warren, S (PI, past); Day, J (RS); Huminik, J (RS); Scrymgeour, A (RS) Collaborating Investigators (Recruitment Sites): Abdouch, Ivan (University of Nebraska Medical Center/Omaha VA, Omaha, NE, USA); Bahtiyar, Gul (SUNY Downstate Medical Center, Brooklyn, NY, USA); Brantley, Paula (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Broyles, Frances E. (Swedish Medical Center, Seattle, WA, USA); Canaris, Gay (University of Nebraska Medical Center/Omaha VA, Omaha, NE, USA); Copeland, Paul (Massachusetts General Hospital, Boston, MA, USA); Craine, Jeri J. (UW Valley Medical Center, Seattle, WA, USA); Fein, Warren L. (Swedish Medical Center, Seattle, WA, USA); Gliwa, Agnieska (SUNY Downstate Medical Center, Brooklyn, NY, USA); Hope, Lisel M. (SUNY Downstate Medical Center, Brooklyn, NY, USA); Lee, Melissa S. (SUNY Downstate Medical Center, Brooklyn, NY, USA); Meiners, Rebecca (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Meiners, Vaughan (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); O’Neal, Hollis (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Park, James E. (UW Valley Medical Center, Seattle, WA, USA); Sacerdote, Alan (SUNY Downstate Medical Center, Brooklyn, NY, USA); Sledge, Jr., Edward (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Soni, Lisa (SUNY Downstate Medical Center, Brooklyn, NY, USA); Steppel-Reznik, Jeanne (Massachusetts General Hospital, Boston, MA, USA); Turchin, Alexander (Massachusetts General Hospital, Boston, MA, USA). Emotional Distress Sub-study: Golden, Sherita H. (Johns Hopkins University, Baltimore, MD, USA); Naik, Aanand D. (Baylor College of Medicine, Houston, Texas, USA); Walker, Elizabeth A. (Albert Einstein College of Medicine, Bronx, NY, USA). Data availability: This manuscript is based on follow-up data and outcome assessments from the 1739 participants enrolled into the Emotional Distress Sub-Study (EDS) of the Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness (GRADE) study. The GRADE and EDS database will be available in 2025 at the NIDDK Data Repository ( https://repository.niddk.nih.gov/study/151 ). Funding: Open Access funding enabled and organized by Projekt DEAL. The GRADE study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under award number U01DK098246. The planning of GRADE was supported by a U34 planning grant from the NIDDK (U34-DK-088043). The American Diabetes Association supported the initial planning meeting for the U34 proposal. The National Heart, Lung, and Blood Institute and the Centers for Disease Control and Prevention also provided funding support. The Department of Veterans Affairs provided resources and facilities. Additional support was provided by NIH through grant numbers P30 DK017047, P30 DK020541, P30 DK020572, P30 DK072476, P30 DK079626, P30 DK092926, U54 GM104940, UL1 TR000170, UL1 TR000439, UL1 TR000445, UL1 TR001102, UL1 TR001108, UL1 TR001409, 2UL1TR001425, UL1 TR001449, UL1 TR002243, UL1 TR002345, UL1 TR002378, UL1 TR002489, UL1 TR002529, UL1 TR002535, UL1 TR002537, UL1 TR002541 and UL1 TR002548. Educational materials (the 4 Steps to Manage Your Diabetes for Life booklet) were provided by the National Diabetes Education Program. Material support in the form of donated medications and supplies was provided by Becton, Dickinson and Company, Bristol-Myers Squibb, Merck & Co. Inc., Novo Nordisk, Roche Diagnostics and Sanofi. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The GRADE Study Research Group is deeply grateful to our participants whose loyal dedication made the GRADE study possible. The GRADE Emotional Distress Sub-Study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under award number R01 DK104845. Additional support was provided by grant number P30 DK111022. Authors’ relationships and activities: DE reports consulting fees from Roche and Dexcom Germany, payment or honoraria from Roche, Dexcom Germany, Sanofi Aventis, Berlin Chemie AG, Boehringer Ingelheim/Lilly and Eli Lilly. CJH reports grants or contracts from the National Institute on Aging (NIA), the NIDDK and JDRF. CP reports grants or contracts from the National Center for Complementary and Integrative Health (NICCH) and ADA. RMC reports grants or contracts from NIH and Dexcom and the chairmanship of the Cincinnati Veterans Affairs Research and Development Committee. WTG reports grants or contracts from NIDDK, Novo Nordisk, Eli Lilly, Epitomee, Neurovalen and Pfizer to his university, consulting fees from Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Pfizer, Fractyl Health, Alnylam Pharmaceuticals, Inogen, Zealand, Aluurion and Merck, payment or honoraria from Brown University, Auburn University, Wayne State University, the University of Illinois, Mount Sinai Hospital, the Cleveland Clinic, the University of Miami, the Georgia Endocrine Society and Auburn University for invited lectureships, participation in a data and safety monitoring board/advisory board for Boehringer Ingelheim and Eli Lilly, and membership of the Lancet Commission on Obesity. TM reports grants or contracts from Abbott, Dexcom, Insulet, Eli Lilly, Medtronic, Novo Nordisk, Sanofi and Tandem, payment or honoraria from Abbott and Dexcom, support for attending meetings or travel from Abbott, the ADA and the American College of Physicians (ACP) and participation in a data and safety monitoring board/advisory board for Eli Lilly. HJW reports grants or contracts from Abbott, Dexcom, the ADA and the Academy of Nutrition and Dietetics, consulting fees from Dexcom, payment or honoraria from Abbott, and support for attending meetings or travel from the ADA. JSG reports participation in a data and safety monitoring board/advisory board for Vanderbilt University. HK-S, DU, HW, GC-R, VLA and AC declare that there are no relationships or activities that might bias, or be perceived to bias, their work. Contribution statement: All authors affirm that authorship is merited based on the ICMJE authorship criteria. DE, HK-S, DU, HW, CJH, GC-R, VLA, WTG, AC and JSG contributed to the conception and/or design of the study. VLA, RMC, WTG and TM contributed to the acquisition of data. DU and HW conducted the statistical analysis. All authors contributed to the interpretation of data and results. HK-S and JSG acquired funding. HK-S, DU, VLA, WTG, HW and JSG contributed to the supervision and management of the research. DE, HK-S, DU, HW, WTG and JSG drafted the manuscript. All authors contributed to the critical review of the manuscript and approved the final version to be published. DE, DU and HW are the guarantors of this work, and as such had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

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