Introduction and Objective: Metabolic-bariatric surgery (MBS) is highly effective vs. medical-lifestyle intervention (MLI) for ameliorating T2D and promoting remission. Previous models of patient characteristics to predict T2D remission and relapse have used retrospective observational data, often without directly comparing different MBS procedures. The current study identifies clinical characteristics that predict T2D remission and relapse over 14 years among patients previously randomized to various MBS operations vs. MLI.Methods: ARMMS-T2D is a multicenter, prospective, observational study of diabetes outcomes among 262 patients (166 MBS, 96 MLI) with obesity and T2D who were initially randomized to MBS (RYGB, sleeve gastrectomy [SG], or adjustable gastric band [AGB]) vs. MLI. Baseline mean±SD age = 49.9±8.3 yrs; BMI = 36.4±3.5 kg/m²; HbA1c = 8.5±1.5 %; 68% female; 31% Black. T2D remission was defined as HbA1c <6.5% on no diabetes medications for 3 months, and relapse as a rise in HbA1c to ≥6.5% or need for diabetes medications.Results: Over 14 years of follow-up, T2D remission occurred in 58% of participants randomized to MBS vs. 3% with MLI. Univariate predictors of remission were shorter T2D duration at baseline (P<0.001), no insulin usage (P<0.001), fewer diabetes medication classes used (P=0.001), greater body weight (P=0.024), higher fasting C-peptide (P=0.016) and insulin (P=0.015) levels, intervention type (RYGB > SG > AGB > MLI), and greater weight loss at 1 year (P<0.001). In multivariate analyses, predictors included baseline T2D duration (P=0.004), no insulin use (P=0.001), intervention type (in the same order as above), and weight loss at 1 year (P<0.001). Diabetes relapse after remission was predicted only by longer T2D duration (P=0.004) and a greater number of diabetes medications used (P=0.007).Conclusion: Knowledge of clinical characteristics that predict whether different MBS procedures will produce diabetes remission should guide patients and clinicians in surgical decision-making.
D.C. Simonson: Board Member; Current; Phase V Technologies, Inc. Stock/Shareholder; Current; GI Windows. D.E. Cummings: None. P. Schauer: Other – Honorarium for speaking engagement; Current; Ethicon, Inc. Research Support; Ended; Ethicon, Inc. Other – Honorarium for speaking engagement; Current; Medtronic. Research Support; Current; Lilly. Advisory Panel; Current; Regeneron. Stock/Shareholder; Current; SE Healthcare LLC, Mediflix, MHI International. Other – Honorarium for speaking engagement; Current; Lilly. A. Aminian: Research Support; Current; Medtronic. Consultant; Current; Medtronic. Research Support; Current; Ethicon, Inc. Consultant; Current; Ethicon, Inc. Research Support; Current; Amgen Inc. Advisory Panel; Current; Eli Lilly and Company. Advisory Panel; Ended; Amylyx. B. Hu: None. D. Arterburn: None. J. Jakicic: Advisory Panel; Current; Wondr Health, Inc. S.R. Kashyap: Other – adjudication committee member; Current; Medpace. Other – advisor; Current; Madrigal Pharmaceuticals, Inc. Other – clinical trial; Ended; Fractyl Health, Inc., Janssen Pharmaceuticals, Inc. A.H. Vernon: None. W.F. Gourash: None. A.P. Courcoulas: None. M.E. Patti: Other – My institution receives research funding for clinical trial.; Current; Recordati S.p.A, Amylyx. Other – Data Safety Monitoring Board; Current; Fractyl Health, Inc. J.P. Kirwan: Consultant; Current; Eli Lilly and Company. Research Support; Current; Eli Lilly and Company. Advisory Panel; Ended; Novo Nordisk.
National Institutes of Health (U01DK114156)
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