Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01930448
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 0
• Location: 1
• Duration (Months): 72
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

Condition or Disease	Intervention/Treatment	Phase
Gastric Bypass Surgery; Gastric Banding; Type 2 Diabetes

Detailed Description

All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
gastric bypass Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
gastric banding surgical group of obese patients with type 2 diabetes undergoing gastric banding

Outcome Measures

Primary Outcome Measures

1. Change in Incretin Effect [Before surgery, 1, 12, and 24 months post]

   Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)

Secondary Outcome Measures

1. Change in Body Composition [Before surgery, 12, and 24 months post]

   Body composition measurements to determine body volume, size, and fat

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research Center	New York	New York	United States	10025

Sponsors and Collaborators

• St. Luke's-Roosevelt Hospital Center
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Blandine Laferrere, MD, New York Obesity Nutrition Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT01930448
• Other Study ID Numbers: 03-108
• First Posted: Aug 29, 2013
• Last Update Posted: Sep 11, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Bariatric; Gastric Bypass; Gastric Banding,; Type 2 Diabetes; Incretins; GLP-1; GIP; Insulin secretion; insulin sensitivity
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Loss

Study Results

No Results Posted as of Sep 11, 2015