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A Study to Examine Changes in GIP Plasma Levels Following Gastric Bypass Surgery in Obese Patients

This study has been terminated.
(Insufficient funding)
Information provided by (Responsible Party):
Caroline Apovian, Boston Medical Center Identifier:
First received: September 13, 2005
Last updated: January 25, 2017
Last verified: January 2017
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.

Obesity Type 2 Diabetes Mellitus Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Caroline Apovian, Boston Medical Center:

Primary Outcome Measures:
  • GIP area under the curve after OGTT

Secondary Outcome Measures:
  • Other GI peptides and hormones after OGTT

Enrollment: 5
Study Start Date: March 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Laparoscopic gastric bypass
Patients undergoing Laparoscopic gastric bypass
Open gastric bypass
Patients undergoing Open gastric bypass

  Show Detailed Description


Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00207389

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
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

Bayliss WM, Starling EH. Croonian lecture. The chemical regulation of the secretory process. Proc R Soc Lond 1904(73):310-332.
Kosaka T, Lim RKS. Demonstration of the humoral agent in fat inhibited gastric secretion. Proc Soc Exp Biol Med 1930;27:890-891.
Arnold R, Ebert R, Creutzfeldt W, H.D. B, Börger H. Inhibition of gastric acid secretion by gastric inhibitory polypeptide (GIP) in man. Scand J Gastroenterol 1978;13(Suppl 48):11.

Responsible Party: Caroline Apovian, Principal Investigator, Boston Medical Center Identifier: NCT00207389     History of Changes
Other Study ID Numbers: H-22610
Study First Received: September 13, 2005
Last Updated: January 25, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Caroline Apovian, Boston Medical Center:
Incretins:GIP , GLP-1
Gastric bypass surgery
Laparoscopic gastric bypass surgery
Postprandial expression of GIP

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism processed this record on August 17, 2017