Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35

Status unconfirmed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (\< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid ultrasound as a marker of cardiovascular function, and alterations in diabetic medications. Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The pre-surgery evaluation is directed toward establishing the existence of diabetes related complications prior to surgery. After surgery subjects will be closely monitored for complications and required changes in their diabetes management. Repeat assessments will be made at 1, 3, 6, and 12 months and at two years.

Key facts

Study ID

NCT00999050

Run by

Weill Medical College of Cornell University

People needed

50

Starts

2009-10-01

Expected to finish

2013-11-01

Last updated by the study team

2011-01-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult males and females who meet the following inclusion criteria will be offered the opportunity to participate in the study:
• Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria:
• normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 Diabetes Mellitus
• positive glucagon test to confirm T2DM
• fasting plasma glucose of 126 mg/dl or more on at least two occasions
• Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2
• History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years correlates with failure to achieve diabetes resolution after gastric bypass
• No contraindication for surgery or general anesthesia as determined by a multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist, dietitian, psychologist)
• Between 18 and 65 year of age
• Able to provide informed consent
• If a female with reproductive potential, she has to agree to use a reliable method of birth control for at least one year from the date of surgery

You may not qualify if…

• Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
• Enrollment in another clinical study, which involves an investigational drug
• Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus
• Significant renal failure of chronic liver disease (except NAFLD)
• Major psychological disorders
• Pregnancy - all female subjects will have serum beta-hCG prior to operation, and must use birth control of their choice to avoid pregnancy during the first year after surgery
• Previous gastric or esophageal surgery
• Immunosuppressive drugs including corticosteroids
• Coagulopathy defined as an INR > 1.5 or platelet count < 50,000/µl
• Anemia defined as a Hb <10.0 g/dl
• Inflammatory bowel diseases or other medical condition that would serve as a contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency)
• A severe concurrent illness that is likely to limit life or require extensive systemic treatment (e.g. cancer)
• A pre-existing major complication of diabetes:
• unstable, proliferative retinopathy
• severe autonomic cardiac neuropathy or intestinal neuropathy
• Myocardial infarction within the previous year, current unstable angina, or poorly-controlled congestive heart failure (Stage III)

Where it is running

• Weill Cornell Medical College New York Prysbyterian Hosptial — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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