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Improvement of Insulin Resistance After Bariatric Surgery

NCT03853590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-02-25

No results posted yet for this study

Summary

Non-randomized open label study to investigate factors mediating changes in insulin sensitivity, glucose tolerance and other metabolic outcomes after bariatric surgery.

Conditions

  • Obesity
  • Bariatric Surgery Candidate
  • Insulin Tolerance

Interventions

PROCEDURE

Roux-en-Y gastric bypass

Creation of a small pouch from the stomach and connection of the newly created pouch directly to the small intestine so that swallowed food bypasses most of the stomach and the first section of the small intestine.

PROCEDURE

Laparoscopic adjustable gastric banding

Placement of a soft silicone ring with an expandable balloon in the center, around the top part of the stomach to create a two-compartment stomach, with a much smaller top part above the band. The subject will eat enough food only to fill the top part of the stomach decreasing caloric consumption.

Sponsors & Collaborators

Principal Investigators

  • Christos Mantzoros, MD, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-25
Primary Completion
2013-04-01
Completion
2015-05-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853590 on ClinicalTrials.gov