Clinical Trial Information
Principal Investigator: David Sarwer, Ph.D., Thomas Wadden, Ph.D., Noel Williams, MD, BCh, MCh, FRCSI, FRCS(Gen)
Title: Surgery Or Lifestyle Intervention for Diabetes (SOLID)
Purpose: This research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes.
Brief Description: Eligible patients will be randomly assigned to one of 2 types of weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or to intensive lifestyle modification. Participants will be closely followed for one year to compare the effects of these treatments on diabetes remission.
- Ages 18 to 65 years old.
- Diagnosis of type 2 diabetes. Diabetes will be defined by a pre-existing diagnosis (confirmed by the primary care provider), the use of oral antidiabetic medications (orals or injectables), or a fasting plasma glucose > 126 mg/dl on two occasions, or a fasting glucose > 126 mg/dl with a 2-hour postprandial glucose > 200 mg/dl. When diabetes status cannot be ascertained by history, we will draw two fasting blood samples for analysis of glucose or perform an oral glucose tolerance test.
- 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.
- Willingness to accept randomization to each group.
- Ability to communicate with the investigator and be legally competent, provide written informed consent.
- 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 > 8.5% (considered too high to undergo bariatric surgery by our surgical team).
- 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 antidepressents 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.
- 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.
Compensation: Participants can earn up to $875 for the completion of all study visits.