Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes

NCT02328599 | Completed DMC

• 2 other identifiers: COV EES-14606U01DK114156
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 4

Brief Summary

Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years. Following this, a consortium was created to pool data and continue to follow study participants. This early collaboration of the 4 groups of investigators was supported by Industry sponsors (Ethicon, Inc and Medtronic-MITG). Now, the investigators have successfully received a grant from the NIH, as the sole supporter of continued observational follow-up of study participants. The continuing aim of this study is to combine data from the 4 studies and follow the original randomized subjects for an additional 5 years of follow-up. The purpose of the study is to determine the longer term durability and effectiveness of bariatric surgery compared to medical/lifestyle intervention on the treatment of type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Between group (medical vs. surgical) in HbA1c from baseline to 7 year for all participants and up to 13 years for the earliest enrollees

  7 years and up to 13 years for earliest enrollees

Secondary Outcomes (1)

• HbA1c < 6.5%

  7 years and each annual visit through the last known follow-up for all patients up to 13 years

Other Outcomes (6)

• HbA1c >6.5%

  7-13 years

• change in body weight measured in BMI

  7 years and up to 13 years for earliest enrollees

• change in fasting glucose

  7 years and up to 13 years for earliest enrollees

Study Arms (2)

Surgical

Prior Bariatric surgery

Procedure: Bariatric surgery involving Roux-en-Y gastric bypass; Procedure: Bariatric surgery involving Laparoscopic adjustable gastric banding; Procedure: Bariatric surgery involving Laparoscopic sleeve gastrectomy

Non-surgical

Medical / Lifestyle management

Interventions

Bariatric surgery involving Roux-en-Y gastric bypass PROCEDURE

Subjects previously underwent Bariatric surgery involving Roux-en-Y gastric bypass (RYGB) surgery at one of the 4 participating sites and will be followed prospectively.

Also known as: RYGB

Surgical

Bariatric surgery involving Laparoscopic adjustable gastric banding PROCEDURE

Subjects previously underwent Bariatric surgery involving laparoscopic adjustable gastric banding (LAGB) surgery at one of the 4 participating sites and will be followed prospectively.

Also known as: LAGB

Surgical

Bariatric surgery involving Laparoscopic sleeve gastrectomy PROCEDURE

Subjects previously underwent Bariatric surgery involving laparoscopic sleeve gastrectomy (LSG) surgery at one of the 4 participating sites and will be followed prospectively.

Also known as: LSG

Surgical

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who were previously enrolled in a Randomized Control Trial (RCT) at one of the four participating sites who initiated one of the intervention procedures - bariatric surgery or medical/lifestyle therapy.

You may qualify if:

• Candidate for general anesthesia or unsupervised exercise.
• Age ≥20 and ≤65 years.
• Body mass index \>27 and ≤45 kg/m2.
• Diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on HbA1c, fasting plasma glucose, and/or oral glucose tolerance test (OGTT) results, according to American Diabetes Association criteria.
• Ability and willingness to participate in the study and agree to any of the research arms.
• Able to understand the options and to comply with the requirements of each program.
• Negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant).

You may not qualify if:

• Subjects who were randomized in one of the four RCTs but never initiated intervention / did not receive randomized treatment
• Refusal to sign informed consent

Sponsors & Collaborators

• Ali Aminian: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• The Cleveland Clinic: collaborator

Study Sites (4)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic Digestive Disease Institute

Cleveland, Ohio, 44195, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington

Seattle, Washington, 98108, United States

Location

Related Publications (34)

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  PMID: 17715409 BACKGROUND

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• Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. doi: 10.1097/01.sla.0000089851.41115.1b.

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  PMID: 24018646 BACKGROUND

• Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008 Jan 23;299(3):316-23. doi: 10.1001/jama.299.3.316.

  PMID: 18212316 BACKGROUND

• Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.

  PMID: 22449319 BACKGROUND

• Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.

  PMID: 22449317 BACKGROUND

• Ikramuddin S, Korner J, Lee WJ, Connett JE, Inabnet WB, Billington CJ, Thomas AJ, Leslie DB, Chong K, Jeffery RW, Ahmed L, Vella A, Chuang LM, Bessler M, Sarr MG, Swain JM, Laqua P, Jensen MD, Bantle JP. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. JAMA. 2013 Jun 5;309(21):2240-9. doi: 10.1001/jama.2013.5835.

  PMID: 23736733 BACKGROUND

• Halperin F, Ding SA, Simonson DC, Panosian J, Goebel-Fabbri A, Wewalka M, Hamdy O, Abrahamson M, Clancy K, Foster K, Lautz D, Vernon A, Goldfine AB. 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. JAMA Surg. 2014 Jul;149(7):716-26. doi: 10.1001/jamasurg.2014.514.

  PMID: 24899464 BACKGROUND

• Courcoulas AP, Goodpaster BH, Eagleton JK, Belle SH, Kalarchian MA, Lang W, Toledo FG, Jakicic JM. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):707-15. doi: 10.1001/jamasurg.2014.467.

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• Arterburn DE, Bogart A, Sherwood NE, Sidney S, Coleman KJ, Haneuse S, O'Connor PJ, Theis MK, Campos GM, McCulloch D, Selby J. A multisite study of long-term remission and relapse of type 2 diabetes mellitus following gastric bypass. Obes Surg. 2013 Jan;23(1):93-102. doi: 10.1007/s11695-012-0802-1.

  PMID: 23161525 BACKGROUND

• Cummings DE, Flum DR. Gastrointestinal surgery as a treatment for diabetes. JAMA. 2008 Jan 23;299(3):341-3. doi: 10.1001/jama.299.3.341. No abstract available.

  PMID: 18212321 BACKGROUND

• Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. doi: 10.1097/01.sla.0000224726.61448.1b.

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• Zimmet P, Alberti KG, Rubino F, Dixon JB. IDF's view of bariatric surgery in type 2 diabetes. Lancet. 2011 Jul 9;378(9786):108-10. doi: 10.1016/S0140-6736(11)61027-1. No abstract available.

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• Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914.

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  BACKGROUND

• Patti ME, Hu B, Kirschling S, Wang HJ, Foster K, Sarig Y, Simonson DC, Wolfs D, Arterburn D, O'Brien MJ, Vernon AH, Jakicic JM, Laffel L, Ojukwu S, Kashyap SR, Aminian A, Schauer PR, Cummings DE, Gourash WF, Courcoulas A, Kirwan JP. Effect of Social Vulnerability on Efficacy of Bariatric Surgery Versus Medical and Lifestyle Intervention for Type 2 Diabetes: Analysis of the ARMMS-T2D Consortium of Randomized Trials. Ann Intern Med. 2026 Jan 20:10.7326/ANNALS-24-01882. doi: 10.7326/ANNALS-24-01882. Online ahead of print.

  PMID: 41554124 DERIVED

• Courcoulas AP, Patti ME, Hu B, Arterburn DE, Simonson DC, Gourash WF, Jakicic JM, Vernon AH, Beck GJ, Schauer PR, Kashyap SR, Aminian A, Cummings DE, Kirwan JP. Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes. JAMA. 2024 Feb 27;331(8):654-664. doi: 10.1001/jama.2024.0318.

  PMID: 38411644 DERIVED

• Kirwan JP, Courcoulas AP, Cummings DE, Goldfine AB, Kashyap SR, Simonson DC, Arterburn DE, Gourash WF, Vernon AH, Jakicic JM, Patti ME, Wolski K, Schauer PR. Diabetes Remission in the Alliance of Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D). Diabetes Care. 2022 Jul 7;45(7):1574-1583. doi: 10.2337/dc21-2441.

  PMID: 35320365 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study specific blood and urine specimens will be analyzed at a central laboratory. Participation in the research repository is optional. Blood will be drawn and stored at each site for later analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aminian Ali, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• John Kirwan, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 31, 2014
• Study Start: April 10, 2018
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: March 31, 2026

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)