Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes

Completed · Not applicable

Conditions studied: Obesity, Type 2 Diabetes

In brief

The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.

Key facts

Study ID

NCT01278823

Run by

The Cleveland Clinic

People needed

18

Starts

2011-01-01

Expected to finish

2017-02-15

Last updated by the study team

2019-07-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• candidate for general surgery
• 18 to 60 years old
• BMI 27-43
• type 2 diabetes
• willing to participate in either study arm
• understand and comply with requirements of each arm
• not pregnant
• willing to use reliable birth control for duration of study

You may not qualify if…

• prior bariatric surgery of any type
• prior complex abdominal surgery
• abdominal, thoracic, pelvic, obstetrical surgery within last 6 months
• significant cardiovascular disease
• kidney disease with a creatinine greater than or equal to 1.8 mg/dl
• chronic liver disease except for NAFLD/NASH
• celiac, malabsorptive, inflammatory bowel disorders
• psychiatric disorders requiring 3 or more medications
• pregnancy
• cancer except squamous or basal cell skin cancer or cancer in remission
• anticoagulation therapy that can't be stopped for surgery
• clotting disorders
• severe pulmonary disease

Where it is running

• Cleveland Clinic Bariatric and Metabolic Institute, Department of Pathobiology — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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