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

NCT00207389 | Terminated

• 1 other identifier: H-22610
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes Mellitus; Insulin Resistance

Keywords

Incretins:GIP , GLP-1; Gastric bypass surgery; Laparoscopic gastric bypass surgery; Postprandial expression of GIP

Outcome Measures

Primary Outcomes (1)

• GIP area under the curve after OGTT

Secondary Outcomes (1)

• Other GI peptides and hormones after OGTT

Study Arms (2)

Laparoscopic gastric bypass

Patients undergoing Laparoscopic gastric bypass

Open gastric bypass

Patients undergoing Open gastric bypass

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (10)

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  PMID: 14149200 BACKGROUND

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  PMID: 12068290 BACKGROUND

• Bayliss WM, Starling EH. Croonian lecture. The chemical regulation of the secretory process. Proc R Soc Lond 1904(73):310-332.

  BACKGROUND

• GREGORY RA, TRACY HJ. THE CONSTITUTION AND PROPERTIES OF TWO GASTRINS EXTRACTED FROM HOG ANTRAL MUCOSA. Gut. 1964 Apr;5(2):103-14. No abstract available.

  PMID: 14159395 BACKGROUND

• Jorpes E, Mutt V. Cholecystokinin and pancreozymin, one single hormone? Acta Physiol Scand. 1966 Jan-Feb;66(1):196-202. doi: 10.1111/j.1748-1716.1966.tb03185.x. No abstract available.

  PMID: 5935672 BACKGROUND

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  BACKGROUND

• Brown JC, Pederson RA, Jorpes E, Mutt V. Preparation of highly active enterogastrone. Can J Physiol Pharmacol. 1969 Jan;47(1):113-4. doi: 10.1139/y69-020. No abstract available.

  PMID: 5761841 BACKGROUND

• Cleator IG, Gourlay RH. Release of immunoreactive gastric inhibitory polypeptide (IR-GIP) by oral ingestion of food substances. Am J Surg. 1975 Aug;130(2):128-35. doi: 10.1016/0002-9610(75)90360-8. No abstract available.

  PMID: 1098505 BACKGROUND

• Villar HV, Fender HR, Rayford PL, Bloom SR, Ramus NI, Thompson JC. Suppression of gastrin release and gastric secretion by gastric inhibitory polypeptide (GIP) and vasoactive intestinal polypeptide (VIP). Ann Surg. 1976 Jul;184(1):97-102. doi: 10.1097/00000658-197607000-00016.

  PMID: 938120 BACKGROUND

• Arnold R, Creutzfeldt W, Ebert R, Becker HD, Borger HW, Schafmayer A. Serum gastric inhibitory polypeptide (GIP) in duodenal ulcer disease: relationship to glucose tolerance, insulin, and gastrin release. Scand J Gastroenterol. 1978;13(1):41-7. doi: 10.3109/00365527809179804.

  PMID: 635445 BACKGROUND

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Caroline Apovian, MD

  Boston University Medical Cneter

  PRINCIPAL INVESTIGATOR

• Michael Wolfe, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Marie Mcdonnell, MD

  Boston University

  STUDY CHAIR

• Harmony Allison, MD

  Boston University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)