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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Columbia University |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00627484 |
Purpose
The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss by intravenous glucose tolerance test and body composition will be measured by magnetic resonance imaging.
| Condition | Intervention |
|---|---|
|
Obesity, Type 2 Diabetes Mellitus, Insulin Resistance |
Procedure: gastric bypass surgery Behavioral: Liquid Diet |
| Study Type: | Interventional |
| Study Design: | Basic Science, Open Label, Uncontrolled, Parallel Assignment |
| Official Title: | Changes in Insulin Sensitivity After Weight Loss Induced by Diet or Bariatric Surgery |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Gastric Bypass Surgery
|
Procedure: gastric bypass surgery
gastric bypass surgery
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2: Active Comparator
Liquid Diet
|
Behavioral: Liquid Diet
Weight Loss with calorie restricted liquid diet
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gerardo Febres, MD | 212-342-0281 | |
| Contact: Judith Korner, MD, PhD | 212 305-3725 | jk181@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Gerardo Febres, MD 212-342-0281 | |
| Contact: Judith Korner, MD, PhD 212 305-3725 jk181@columbia.edu | |
| Principal Investigator: Judith Korner, MD, PhD | |
| Principal Investigator: | Judith Korner, MD,PhD | Columbia University |
More Information
| Responsible Party: | Columbia University ( Judith Korner, MD, PhD ) |
| Study ID Numbers: | 2401, DK072011 |
| Study First Received: | February 28, 2008 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00627484 |
| Health Authority: | United States: Institutional Review Board |
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Insulin resistance Insulin sensitivity bariatric surgery |
diabetes calorie restriction body composition |
|
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Insulin Body Weight Signs and Symptoms Hyperinsulinism |
Diabetes Mellitus, Type 2 Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders |
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Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
