Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric banding can improve remission of type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Carolina University
• Treatments: Liraglutide; Orlistat

Criteria

Inclusion Criteria:

Subjects will be eligible if they meet the following criteria:

• male or female,

• age 25-70 years,

• BMI 26-65,

• type 2 diabetic,

• weight stable for 3 months,

• status post laparoscopic adjustable gastric banding (LAGB) for at least 1 year,

• hemoglobin a1c 7-10%;

• on any diabetic regimen including insulin except for thiazolidinedione use in the past 6 months.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

• prior history of pancreatitis,

• prior history of gastroparesis,

• glomerular filtration rate (GFR) < 50,

• history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer,

• history of cholelithiasis,

• history of hyperoxaluria or calcium oxalate nephrolithiasis,

• abnormal AST,

• ALT elevation,

• current or past history of liver disease,

• history of Roux-en-y gastric bypass or gastric sleeve or any other bariatric procedure other than LAGB,

• type 1 diabetes,

• any gastrointestinal disease causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue),

• prior history of Orlistat or incretin therapy use in past 3 months,

• unwilling or unable to complete scheduled testing,

• thiazolidinedione use within past 6 months,

• any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study.

Patients who have had organ transplantation are on chronic anticoagulation, pregnant or have A1C values > 10% will also be excluded.