NCT01930448

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

6 years

First QC Date

August 20, 2013

Last Update Submit

September 9, 2015

Conditions

Gastric Bypass SurgeryGastric BandingType 2 Diabetes

Keywords

BariatricGastric BypassGastric Banding,Type 2 DiabetesIncretinsGLP-1GIPInsulin secretioninsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in Body Composition

    Before surgery, 12, and 24 months post

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

severly obese patients with type 2 diabetes undergoing gastric bypass or gastric banding

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Blandine Laferrere, MD

    New York Obesity Nutrition Research Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 29, 2013

Study Start

September 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

US(1)