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

NCT ID: NCT01930448

Last Updated: 2015-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Gastric Bypass Surgery Gastric Banding Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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gastric bypass

Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery

No interventions assigned to this group

gastric banding

surgical group of obese patients with type 2 diabetes undergoing gastric banding

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blandine Laferrere, MD

Role: PRINCIPAL_INVESTIGATOR

New York Obesity Nutrition Research Center

Locations

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

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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03-108

Identifier Type: -

Identifier Source: org_study_id

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