Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Completed · Not applicable

Conditions studied: Obesity, Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT01044602

Run by

David Bradley MD

People needed

120

Starts

2010-01-01

Expected to finish

2014-01-01

Last updated by the study team

2015-04-21

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 25 to 70
• BMI 35 or greater
• HbA1c>6.5%
• Stable weight
• Stable medications

You may not qualify if…

• 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

Where it is running

• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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