Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Other: Laboratory evaluations, sleep study; Other: Best Medical Management; Procedure: Roux-en-Y gastric bypass surgery

• Registration Number: NCT01044602
• Lead Sponsor: David Bradley MD

Brief Summary

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).

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Treatment	Laboratory evaluations, sleep study	Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.
Best Medical Management	Best Medical Management	Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.
Surgical Treatment	Roux-en-Y gastric bypass surgery	Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.
Best Medical Management	Laboratory evaluations, sleep study	Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in control of chronic co-morbidities	2 years
Improvement in glucose control	2 years
Identify predictors of success with regard to improved co-morbidities and velocity of weight loss	2 years

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States