Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

April 20, 2015 updated by: David Bradley MD

Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study

Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 25 to 70
  • BMI 35 or greater
  • HbA1c>6.5%
  • Stable weight
  • Stable medications

Exclusion Criteria:

  • Coagulopathy
  • Liver cirrhosis
  • C-peptide <1 ng/ml (off insulin)
  • Diagnosis of severe eating disorder
  • Untreated endocrine disorder
  • Use of medication for weight loss in the past 6 months
  • Use of medication for weight loss in the last 6 months (with the exception of orlistat)
  • Pregnancy
  • Coagulopathy
  • Liver cirrhosis
  • Incurable, malignant, or debilitating disease
  • Severe eating disorder
  • Use of weight loss medication in the last 6 months, with the exception of orlistat
  • Untreated endocrine disorder
  • Pregnant
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Best Medical Management
Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.
Other: Laboratory evaluations, sleep study
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
Other: Best Medical Management
Standard of care.
Active Comparator: Surgical Treatment
Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.
Other: Laboratory evaluations, sleep study
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
Procedure: Roux-en-Y gastric bypass surgery
Surgical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
Time Frame: 2 years
2 years
Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in glucose control
Time Frame: 2 years
2 years
Improvement in control of chronic co-morbidities
Time Frame: 2 years
2 years
Identify predictors of success with regard to improved co-morbidities and velocity of weight loss
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Bradley MD

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Asem Ali, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009H0282
  • MS vs. MM for DM2 (Other Identifier: Dept identifier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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