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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00207389
Recruitment Status : Terminated (Insufficient funding)
First Posted : September 21, 2005
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Obesity Type 2 Diabetes Mellitus Insulin Resistance

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Study Design

Study Type : Observational
Actual Enrollment : 5 participants
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
Study Start Date : March 2004
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Laparoscopic gastric bypass
Patients undergoing Laparoscopic gastric bypass
Open gastric bypass
Patients undergoing Open gastric bypass


Outcome Measures

Primary Outcome Measures :
  1. GIP area under the curve after OGTT

Secondary Outcome Measures :
  1. Other GI peptides and hormones after OGTT

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207389


Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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:
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
ClinicalTrials.gov Identifier: NCT00207389     History of Changes
Other Study ID Numbers: H-22610
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 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