Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D): Study rationale, design, and methods

Long‐term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D) is a consortium of four randomized trials designed to compare long‐term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes.

[1]  P. Schauer,et al.  Diabetes Remission in the Alliance of Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D). , 2022, Diabetes care.

[2]  F. Rubino,et al.  Consensus report: definition and interpretation of remission in type 2 diabetes , 2021, Diabetologia.

[3]  N. Syn,et al.  Association of metabolic–bariatric surgery with long-term survival in adults with and without diabetes: a one-stage meta-analysis of matched cohort and prospective controlled studies with 174 772 participants , 2021, The Lancet.

[4]  F. Rubino,et al.  Metabolic surgery versus conventional medical therapy in patients with type 2 diabetes: 10-year follow-up of an open-label, single-centre, randomised controlled trial , 2021, The Lancet.

[5]  8. Obesity Management for the Treatment of Type 2 Diabetes: Standards of Medical Care in Diabetes-2021. , 2021, Diabetes care.

[6]  2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. , 2020, Diabetes care.

[7]  A. Courcoulas,et al.  Benefits and Risks of Bariatric Surgery in Adults: A Review. , 2020, JAMA.

[8]  J. DeLany,et al.  Bariatric Surgery vs. Lifestyle Intervention for Diabetes Treatment: Five Year Outcomes From a Randomized Trial. , 2020, The Journal of clinical endocrinology and metabolism.

[9]  M. Patti,et al.  Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial. , 2019, Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery.

[10]  M. Kattan,et al.  Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity. , 2019, JAMA.

[11]  A. Goldfine,et al.  Clinical and Patient-Centered Outcomes in Obese Patients With Type 2 Diabetes 3 Years After Randomization to Roux-en-Y Gastric Bypass Surgery Versus Intensive Lifestyle Management: The SLIMM-T2D Study , 2018, Diabetes Care.

[12]  Avis J. Thomas,et al.  Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study , 2018, JAMA.

[13]  Deepak L. Bhatt,et al.  Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5‐Year Outcomes , 2017, The New England journal of medicine.

[14]  V. Montori,et al.  Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations. , 2017, JAMA.

[15]  B. Wolfe,et al.  Type 2 Diabetes Remission Rates After Laparoscopic Gastric Bypass and Gastric Banding: Results of the Longitudinal Assessment of Bariatric Surgery Study , 2016, Diabetes Care.

[16]  B. Wolfe,et al.  Clinical Outcomes of Metabolic Surgery: Efficacy of Glycemic Control, Weight Loss, and Remission of Diabetes , 2016, Diabetes Care.

[17]  D. Flum,et al.  Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial , 2016, Diabetologia.

[18]  C. Loria,et al.  Overview of the obesity intervention taxonomy and pooled analysis working group , 2016, Translational behavioral medicine.

[19]  C. Loria,et al.  Deconstructing interventions: approaches to studying behavior change techniques across obesity interventions , 2016, Translational behavioral medicine.

[20]  A. De Gaetano,et al.  Determinants of Diabetes Remission and Glycemic Control After Bariatric Surgery , 2015, Diabetes Care.

[21]  J. DeLany,et al.  Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. , 2015, JAMA surgery.

[22]  A. Goldfine,et al.  Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial. , 2015, The Journal of clinical endocrinology and metabolism.

[23]  A. Goldfine,et al.  Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. , 2014, JAMA surgery.

[24]  F. Toledo,et al.  Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. , 2014, JAMA surgery.

[25]  C. Bouchard,et al.  Association of bariatric surgery with long-term remission of type 2 diabetes and with microvascular and macrovascular complications. , 2014, JAMA.

[26]  Deepak L. Bhatt,et al.  Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. , 2014, The New England journal of medicine.

[27]  Deepak L. Bhatt,et al.  Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials , 2013, BMJ.

[28]  R. Abramof Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes , 2012 .

[29]  Patrick Royston,et al.  Multiple imputation using chained equations: Issues and guidance for practice , 2011, Statistics in medicine.

[30]  R. Little,et al.  Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. , 2011, Clinical chemistry.

[31]  Richard Schulz,et al.  Intervention taxonomy (ITAX): describing essential features of interventions. , 2010, American journal of health behavior.

[32]  John Ioannidis,et al.  Exploring the Geometry of Treatment Networks , 2008, Annals of Internal Medicine.

[33]  S. van Buuren Multiple imputation of discrete and continuous data by fully conditional specification , 2007, Statistical methods in medical research.

[34]  Richard Schulz,et al.  A methodology for describing and decomposing complex psychosocial and behavioral interventions. , 2003, Psychology and aging.

[35]  Richard Schulz,et al.  Using a new taxonomy to combine the uncombinable: integrating results across diverse interventions. , 2003, Psychology and aging.

[36]  J. Robins,et al.  Estimating the causal effect of zidovudine on CD4 count with a marginal structural model for repeated measures , 2002, Statistics in medicine.

[37]  Roderick J. A. Little,et al.  Modeling the Drop-Out Mechanism in Repeated-Measures Studies , 1995 .

[38]  R. Little Pattern-Mixture Models for Multivariate Incomplete Data , 1993 .