Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

Summary

This research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or an intensive lifestyle modification. Participants will be closely followed for one year to compare the effects of these treatments on diabetes remission.

Conditions

• Type 2 Diabetes

Interventions

PROCEDURE

Roux-en-Y Gastric Bypass surgery

Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.

PROCEDURE

Laparoscopic Adjustable Gastric Banding surgery

Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.

BEHAVIORAL

Intensive Lifestyle Modification

Intensive lifestyle modification program for weight loss. Participants randomized to this condition will receive an weekly individual treatment of 30 minutes for the first 6 months and every-other-week sessions from months 7 to 12. Treatment will be provided by a behavioral psychologist or registered dietitian following a structured curriculum used in our prior studies. During the first 4 months, participants will be prescribed a 1000-1200 kcal/d diet that provides four daily servings of meal replacement products (liquid shakes, cereals, meal bars, etc), combined with an evening dinner entree. Each serving of the meal replacement (HMR 170; Boston, MA) will provide 170 calories, with 16 g of protein, 22 g of carbohydrate, and 2 g of fat. Dinner entrees (containing at least 20 g of protein and approximately 220-260 kcal) will be consumed with a garden salad and a serving of fruit (and other vegetables allowed ad libitum throughout the day).

Sponsors & Collaborators

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

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• David B Sarwer, Ph.D. · University of Pennsylvania

• Thomas A Wadden, Ph.D. · University of Pennsylvania

• Noel Williams, M.D. · University of Pennsylvania Department of Surgery

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States

Study Locations