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Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

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ClinicalTrials.gov Identifier: NCT01044602
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
David Bradley MD, The Ohio State University

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).

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Mellitus Other: Laboratory evaluations, sleep study Other: Best Medical Management Procedure: Roux-en-Y gastric bypass surgery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study
Study Start Date : January 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

Secondary Outcome Measures :
  1. Improvement in glucose control [ Time Frame: 2 years ]
  2. Improvement in control of chronic co-morbidities [ Time Frame: 2 years ]
  3. Identify predictors of success with regard to improved co-morbidities and velocity of weight loss [ Time Frame: 2 years ]


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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044602


Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
David Bradley MD
Medtronic - MITG
Investigators
Principal Investigator: Asem Ali, MD Ohio State University

Responsible Party: David Bradley MD, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01044602     History of Changes
Other Study ID Numbers: 2009H0282
MS vs. MM for DM2 ( Other Identifier: Dept identifier )
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by David Bradley MD, The Ohio State University:
Obesity
Type 2 Diabetes Mellitus
Roux-en-Y Gastric Bypass Surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases