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NCT01930448 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn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Status Withdrawn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

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
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