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Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Asem H Ali, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01044602
First received: January 7, 2010
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition Intervention
Obesity
Type 2 Diabetes Mellitus
 Other: Laboratory evaluations, sleep study
Other: Best Medical Management
Procedure: Roux-en-Y gastric bypass surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in glucose control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement in control of chronic co-morbidities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Identify predictors of success with regard to improved co-morbidities and velocity of weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044602

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Asem H Ali
Covidien
Investigators
Principal Investigator: Asem Ali, MD Ohio State University
  More Information

No publications provided

Responsible Party: Asem H Ali, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01044602     History of Changes
Other Study ID Numbers: 2009H0282, MS vs. MM for DM2
Study First Received: January 7, 2010
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Obesity
Type 2 Diabetes Mellitus
Roux-en-Y Gastric Bypass Surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013