Improving Diabetes Through Lifestyle and Surgery Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Johns Hopkins University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in HbA1c from baseline to final data collection
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 30-40 kg/m2 at screening visit 1
- •Age 21-64 years
- •Insured by collaborating insurance plan (Employee Health Plan)
- •Type 2 Diabetes
- •Medically safe to undergo surgery and approved by a psychologist
- •Able to exercise at a moderate level
- •Able to give informed consent
- •Willing to accept randomization to each group
- •Able to communicate (both written and oral) in English
- •Willing to use reliable method of birth control during study and ≥18 months postop (if applicable)
Exclusion Criteria
- •Prior bariatric surgery
- •Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair.
- •Weight loss of ≥ 5% of body weight in the past 6 months
- •Uncontrolled diabetes (HbA1c\>8.5%)
- •Untreated severe diabetic retinopathy
- •Use of thiazolidinediones or insulin currently or within the past 3 months
- •Uncontrolled blood pressure (\>160/100 -may be rescreened)
- •Estimated glomerular filtration rate (GFR)\<30
- •Malignancy (except squamous or basal cell of the skin) in the past 5 years
- •MI, stroke or cardiovascular procedure within 12 months
Outcomes
Primary Outcomes
Change in HbA1c from baseline to final data collection
Time Frame: Average time 6 months
Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.
Secondary Outcomes
- Change in insulin secretion(Average time 6 months)