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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01047735
First received: January 12, 2010
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Obesity
 Procedure: Roux-en-Y Gastric Bypass Surgery
Procedure: Laparoscopic Adjustable Gastric Banding
Behavioral: Lifestyle Weight Loss Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roux-en-Y Gastric Bypass Surgery Procedure: Roux-en-Y Gastric Bypass Surgery
Participants assigned to the Roux-en-Y Gastric Bypass study treatment group, will undergo a surgical procedure meant to limit food and fluid intake and cause nutrients malabsorption to promote weight loss. The surgeon will locate the stomach and small intestines laparoscopically through different tubes that are placed in the abdomen so that the stomach can be bypassed. The stomach will be stapled and divided or partitioned so that only a small section (able to hold 1 to 2 Tablespoons) will remain attached to the esophagus. The surgeon will then divide the small intestine a short distance from where it joins the stomach. The shorter segment leaving the stomach will be stapled to a portion of the undivided intestine. A long arm of the divided intestine will be brought up and stapled to the small portion of the stomach.
Experimental: Laparoscopic Adjustable Gastric Banding Procedure: Laparoscopic Adjustable Gastric Banding
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.
Other Name: LapBand
Experimental: Lifestyle/Behavioral Weight Loss Behavioral: Lifestyle Weight Loss Intervention
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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047735

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Anita P Courcoulas, MD, MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01047735     History of Changes
Other Study ID Numbers: RC1DK086037, RC1DK086037, R01DK095128-01
Study First Received: January 12, 2010
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
21+ years old
Address
Adult
Amputation
Area
Arm
Atheroscleroses
Atherosclerosis
Atherosclerotic
Cardiovascular Disease
Bariatrics
Behavior Conditioning Therapy
Behavior Modification
Behavior Therapy
Behavior Treatment
 Behavior or Life Style Modifications
Behavioral
Behavioral Conditioning Therapy
Behavioral Modification
Behavioral Therapy
Behavioral Treatment
Beta Cell
Blindness
Blood Pressure, High
Blood Vessels
Body Composition
Body Weight decreased
Cancers
Cardiac infarction
Cardiovascular Diseases

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013