The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

NCT01047735 | Active Not Recruiting DMC

• 3 other identifiers: STUDY20060163RC1DK086037R01DK095128-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

Conditions

Type 2 Diabetes Mellitus; Obesity

Keywords

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Outcome Measures

Primary Outcomes (1)

• Feasibility of performing a randomized trial comparing two major types of bariatric surgery versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients with T2DM.

  6 months, 1 year

Secondary Outcomes (1)

• Preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

  6 months, 1 year

Study Arms (3)

Roux-en-Y Gastric Bypass Surgery

EXPERIMENTAL

Roux-en-Y Gastric Bypass Surgery

Procedure: Roux-en-Y Gastric Bypass Surgery

Laparoscopic Adjustable Gastric Banding

EXPERIMENTAL

Laparoscopic Adjustable Gastric Banding

Procedure: Laparoscopic Adjustable Gastric Banding

Lifestyle/Behavioral Weight Loss

EXPERIMENTAL

Lifestyle Weight Loss Intervention

Behavioral: Lifestyle Weight Loss Intervention

Interventions

Roux-en-Y Gastric Bypass Surgery PROCEDURE

Participants assigned to the Roux-en-Y Gastric Bypass treatment group will undergo a surgical procedure that limit foods intake and causes nutrients malabsorption. The procedure is performed with small incisions or laparoscopically. A small stomach pouch is created, the size of an egg, and the small intestine is connected to the pouch. Some of the stomach and small intestine are consequently bypassed by this anatomic change. Those in this treatment group will begin a gradual diet post surgery and will take life long vitamin supplements.

Roux-en-Y Gastric Bypass Surgery

Laparoscopic Adjustable Gastric Banding PROCEDURE

Those assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes.

Also known as: LapBand

Laparoscopic Adjustable Gastric Banding

Lifestyle Weight Loss Intervention BEHAVIORAL

Participants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors.

Lifestyle/Behavioral Weight Loss

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25 to 55 years
• Mild to moderate obesity with a BMI between 30 and 40 kg/m2
• For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose \> 126 mg/dl OR treatment with an anti-diabetic medication
• For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control medically and is recommended for the study by the subject's endocrinologist AND treatment with an anti-diabetic medication
• Willingness to be randomized to a surgical intervention

You may not qualify if:

• Prior bariatric or foregut surgery
• Poor overall general health
• Impaired mental status
• Drug and/or alcohol addiction
• Current smoking
• Pregnant or plans to become pregnant
• Type 1 Diabetes Mellitus
• Portal hypertension and/or Cirrhosis
• Failed study-related nutrition or psychological assessment
• Current participation in any other research study
• Inability to provide informed consent
• Unlikely to comply with study protocol
• Unable to communicate with study staff
• Unable to exercise (walk a city block or a flight of stairs)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

William F Gourash

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 24899268 BACKGROUND

• Courcoulas AP, Gallagher JW, Neiberg RH, Eagleton EB, DeLany JP, Lang W, Punchai S, Gourash W, Jakicic JM. Bariatric Surgery vs Lifestyle Intervention for Diabetes Treatment: 5-Year Outcomes From a Randomized Trial. J Clin Endocrinol Metab. 2020 Mar 1;105(3):866-76. doi: 10.1210/clinem/dgaa006.

  PMID: 31917447 BACKGROUND

• Courcoulas AP, Belle SH, Neiberg RH, Pierson SK, Eagleton JK, Kalarchian MA, DeLany JP, Lang W, Jakicic JM. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. JAMA Surg. 2015 Oct;150(10):931-40. doi: 10.1001/jamasurg.2015.1534.

  PMID: 26132586 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Atherosclerosis; Cardiovascular Diseases; Behavior; Blindness; Hypertension; Neoplasms; Myocardial Infarction; Death; Diabetes Mellitus; Disease; Digestive System Diseases; Inflammation; Insulin Resistance; Renal Insufficiency; Liver Diseases; Obesity, Morbid; Non-alcoholic Fatty Liver Disease; Motor Activity; Body Weight; Weight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Hyperinsulinism; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Fatty Liver; Body Weight Changes

Study Officials

• Anita P Courcoulas, MD, MPH

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: September 1, 2009
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)