- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044602
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
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
-
-
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.
|
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
Standard of care.
|
Active Comparator: Surgical Treatment
Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.
|
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
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
Collaborators
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
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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