Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Sarwer, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01040468
First received: December 24, 2009
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Procedure: Roux-en-Y Gastric Bypass surgery
Procedure: Laparoscopic Adjustable Gastric Banding surgery
Behavioral: Intensive Lifestyle Modification
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lifestyle Intervention Versus Bariatric Surgery for Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary objective of this study is to compare the rates of diabetes remission over one year. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2009
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040468

Locations
United States, Pennsylvania
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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
  More Information

Additional Information:
No publications provided

Responsible Party: David Sarwer, Professor of Psychology in Psychiatry and Surgery, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01040468     History of Changes
Other Study ID Numbers: 809984, 1RC1DK086132
Study First Received: December 24, 2009
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Type 2 Diabetes
Bariatric Surgery
Roux-en-Y Gastric Bypass
Gastric Banding
Obesity
Weight loss
Insulin sensitivity
GLP-1
Meal Challenge
Euglycemic Clamp

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014