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Sponsored by: |
Boston Medical Center |
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Information provided by: | Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT00207389 |
Obesity is a multinational epidemic. There is evidence that despite educational measures and increased public awareness, the number of obese individuals continues to increase. Of the numerous obesity-related comorbidities, type 2 diabetes remains one of the most significant in terms of mortality and health care costs. Gastric Bypass Surgery (GBS) not only offers an effective form of therapy for morbid obesity, but also amelioration of type 2 diabetes mellitus. The normalization of glucose levels in GBS patients occurs within days after surgery and has been shown in surgical literature to be independent of the weight loss after surgery. The proximal gut, the site of release of certain incretins, may play a role in glucose homeostasis in obese individuals with type 2 diabetes mellitus. One such incretin is GIP, which when released into the circulation during the immediate postprandial period, accentuates the insulin response to a glucose meal. It is hypothesized that overactivity of this enteroinsular axis in obese individuals produces cell resistance to insulin and subsequent type 2 diabetes mellitus. A previous study reported elevated fasting GIP levels, as well as an exaggerated GIP response to a glucose meal, in obese subjects, which was significantly reduced months after GBS following weight loss. This pilot study of obese patients scheduled for GBS will compare the serum levels of certain peptides, including GIP, following a glucose meal before and after GBS, before weight loss has occured. In order to reproduce the preoperative state, and therefore to demonstrate the physiologic change, a small group of subjects who undergo open surgery will undergo the same measurements after surgery, but using a model in which the meal traverses the stomach, duodenum and jejunum with the aid of a gastrostomy tube.
Condition | Intervention |
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Obesity Type 2 Diabetes Mellitus Insulin Resistance |
Procedure: Oral glucose tolerance test Procedure: G tube glucose tolerance test |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Pilot Study to Examine the Relationship Between Changes in Plasma GIP Levels and Other Gastrointestinal Peptides Following Gastric Bypass Surgery in Obese Patients |
Estimated Enrollment: | 30 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | March 2005 |
Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Boston University Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Caroline Apovian, MD | Boston University Medical Cneter |
Principal Investigator: | Michael Wolfe, MD | Boston University |
Study Chair: | Marie Mcdonnell, MD | Boston University |
Study Chair: | Harmony Allison, MD | Boston University |
Study ID Numbers: | H-22610 |
Study First Received: | September 13, 2005 |
Last Updated: | November 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00207389 History of Changes |
Health Authority: | United States: Institutional Review Board |
Incretins:GIP , GLP-1 Gastric bypass surgery Laparascopic gastric bypass surgery Postprandial expression of GIP |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Glucagon-Like Peptide 1 Body Weight Hyperinsulinism Signs and Symptoms |
Diabetes Mellitus, Type 2 Incretins Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Hyperinsulinism |
Signs and Symptoms Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders |