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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01930448
• Other study ID #: 03-108
• Status: Withdrawn
• Phase: N/A
• First received: August 20, 2013
• Last updated: September 9, 2015
• Start date: September 2008
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Gastric Banding
• Gastric Bypass Surgery
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research Center	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Incretin Effect	Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)	Before surgery, 1, 12, and 24 months post	No
Secondary	Change in Body Composition	Body composition measurements to determine body volume, size, and fat	Before surgery, 12, and 24 months post	No