A Study to Examine Changes in GIP Plasma Levels Following Gastric Bypass Surgery in Obese Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|
|
Obesity Type 2 Diabetes Mellitus Insulin Resistance |
Procedure: Oral glucose tolerance test Procedure: G tube glucose tolerance test |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
- GIP area under the curve after OGTT
- Other GI peptides and hormones after OGTT
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | March 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 21-64 years of age
- Obese (defined as a body mass index, BMI, > or = 30)
- Type 2 diabetes or impaired glucose tolerance
- Have been selected and scheduled for gastric bypass surgery.
Exclusion Criteria:
- Substance abuse
- Consumption of more than two alcoholic drinks per day
- Use of more than 20 units of insulin (any brand or type) per day
- Fasting blood glucose >180mg/dl on screening bloodwork.
Contacts and Locations| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00207389 History of Changes |
| Other Study ID Numbers: | H-22610 |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 15, 2005 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
Incretins:GIP , GLP-1 Gastric bypass surgery Laparascopic gastric bypass surgery Postprandial expression of GIP |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperinsulinism Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013