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

Withdrawn
Conditions
Gastric Banding
Gastric Bypass Surgery
Type 2 Diabetes
Registration Number
NCT01930448
Lead Sponsor
St. Luke's-Roosevelt Hospital Center
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.

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery
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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Incretin EffectBefore 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
NameTimeMethod
Change in Body CompositionBefore surgery, 12, and 24 months post

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

Trial Locations

Locations (1)

St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research Center

🇺🇸

New York, New York, United States

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