Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID) (SOLID)

August 17, 2016 updated by: University of Pennsylvania

Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Center for Weight and Eating Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18 to 65 years old.
  • Diagnosis of type 2 diabetes.
  • Individuals with a BMI of 30-40 kg/m2
  • Approval for bariatric surgery (as confirmed by medical evaluation)
  • Insurance coverage for bariatric surgery
  • Willingness to change diet, physical activity and weight.
  • Ability to communicate with the investigator and be legally competent, provide written informed consent.

Exclusion Criteria:

  • Diagnosis of type 1 diabetes, diagnosis of maturity-onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA) (all of which are associated with ß-cell destruction), daily insulin requirements > 100 units, and poor preoperative glycemic control, as indicated by a HbA1c > 6.5 - ≤ 8.5 or HbA1c > 8.6 - < 9.5 (individuals with this HbA1c value will require medical clearance and approval from the study physician).
  • Children and adolescents are not eligible to participate in the study.
  • Pregnant women (or those who intend to become pregnant during the study period) and women who are currently breastfeeding are not eligible to participate.
  • Use of medications known to significantly increase body weight, such as chronic systemic steroids or certain psychiatric medications (e.g., lithium tricyclic antidepressants and anti-psychotic agents).
  • Non-ambulatory individuals, defined as those who are unable to walk at least one city block without a cane or walker.
  • Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
  • Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that is uncontrolled, poorly controlled, or, in the opinion of the Investigators, significantly interferes with daily living and functioning.
  • Any current (past 12 months) substance abuse or dependence disorder.
  • Participants with moderate anemia (Hgb < 12 mg/dl for men and Hgb < 11 mg/dl for women)
  • Conditions that may falsely elevate or decrease HbA1c values, including hemolytic or iron-deficiency anemia, hemoglobinopathies, and uremia.
  • Abnormal laboratory tests which are clinically significant per the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Roux-en-Y Gastric Bypass surgery
Surgical intervention for weight loss
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.
ACTIVE_COMPARATOR: Laparoscopic Adjustable Gastric Banding surgery
Surgical intervention for weight loss
Procedure: Laparoscopic Adjustable Gastric Banding surgery
Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.
ACTIVE_COMPARATOR: Intensive Lifestyle Modification
Lifestyle intervention for weight loss
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to compare the rates of diabetes remission over one year.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary objectives of this study are to determine the effects of the three treatment conditions on insulin sensitivity, endogenous glucose production, postprandial insulin release, and levels of gut hormones (including GLP-1).
Time Frame: One year
One year
To compare other benefits (e.g., improvements in quality of life, dietary intake, and physical activity), as well as risks (e.g., hypoglycemia, cholecystitis, early and late surgical complications), of the three interventions.
Time Frame: One year
One year
To examine the attitudes that patients, health care professionals, and insurance providers have toward the use of bariatric surgery to treat type 2 diabetes.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

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

Investigators

  • Principal Investigator: David B Sarwer, Ph.D., University of Pennsylvania
  • Principal Investigator: Thomas A Wadden, Ph.D., University of Pennsylvania
  • Principal Investigator: Noel Williams, M.D., University of Pennsylvania Department of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

December 24, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (ESTIMATE)

December 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 809984
  • 1RC1DK086132 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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