Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044602
• Other study ID #: 2009H0282
• Secondary ID: MS vs. MM for DM
• Status: Completed
• Phase: N/A
• First received: January 7, 2010
• Last updated: April 20, 2015
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Other:
• Laboratory evaluations, sleep study
Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.
• Best Medical Management
Standard of care.

Procedure:
• Roux-en-Y gastric bypass surgery
Surgical treatment.

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
David Bradley MD	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.		2 years	No
Primary	Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia		2 years	No
Secondary	Improvement in glucose control		2 years	No
Secondary	Improvement in control of chronic co-morbidities		2 years	No
Secondary	Identify predictors of success with regard to improved co-morbidities and velocity of weight loss		2 years	No