Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes

Summary

The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, but its role in diabetes management and the nature of its weight-independent anti-diabetes effects are not well established because of a paucity of appropriate randomized trials, the execution of which is hindered by numerous obstacles. The investigators therefore propose a feasibility study to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.

Conditions

• Diabetes Mellitus, Type 2
• Obesity

Interventions

PROCEDURE

laparoscopic Roux-en-Y gastric bypass (RYGB) procedure

The laparoscopic Roux-en-Y gastric bypass (RYGB) procedure is the most commonly performed bariatric procedure in the United States. Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90-cm alimentary limb, 50-cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique.

BEHAVIORAL

Lifestyle Intervention

The lifestyle intervention includes behavior-modification skills counseling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, 5 days per week for 12 months. The diet intervention will be conducted by a research dietician with training in behavior modification, with supervision by Dr. Foster-Schubert. In week 1 the dietician will meet for a 60-minute individual session with participants at the FHCRC Prevention Center. Over the next 23 weeks the dietician will conduct one 30-minute group session per week.

Sponsors & Collaborators

• Kaiser Permanente

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• David E Cummings, MD · University of Washington

• David R Flum, MD, MPH · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2012-06-30

Completion

2015-06-30

Countries

• United States

Study Locations