Improving Diabetes Through Lifestyle and Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Improving Diabetes Through Lifestyle and Surgery Study

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Procedure: Gastric Banding
* Behavioral: Medical Weight Loss
* Procedure: Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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 Known HIV positive or use of anti-HIV therapy (HAART) Unstable angina Significant pulmonary disease with oxygen dependency Chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium) Use of prescription weight loss medication or over-the-counter orlistat in the past 6 months Other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss History of severe depression requiring hospitalization in the past 12 months Severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders Current bulimia nervosa Unable or unwilling to use meal replacement products Consumption of >14 alcoholic drinks/week or > 5 drinks on more than 2 occasions in the past 12 months Use of illicit substances in the past 12 months Cigarette or cigar smoking in the past 2 months Pregnant or nursing within past 6 months Plans to become pregnant within 2 years Plans to relocate from the area within 1 year Another member of household is a study participant or staff in the trial

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric Banding<br>Laparoscopic Adjustable Gastric Banding | Procedure: Gastric Banding<br>* Laparoscopic Adjustable Gastric Banding using the LapBand<br>|
| Active Comparator: Medical Weight Loss<br>Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques | Behavioral: Medical Weight Loss<br>* Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians<br>* Other names: HMR meal replacements will be used;|
| Active Comparator: Gastric Bypass<br>Roux-en-Y Gastric Bypass | Procedure: Gastric Bypass<br>* Laparoscopic Roux-en-Y Gastric Bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to final data collection | Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months. | Average time 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin secretion | Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months. | Average time 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes