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.
Drug: Liraglutide + Orlistat
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01597531
Ages eligible for Study
25 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Subjects will be eligible if they meet the following criteria:
male or female,
age 25-70 years,
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.
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,
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.
All locations for NCT01597531
United States (1)
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 28590
View full eligibility
Tris trial is registered with FDA with number: NCT01597531. The sponsor of the trial is East Carolina University and it is looking for 1 volunteers for the current phase.
Official trial title: LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY
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