Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

Stopped early · Phase 4

Conditions studied: Type 2 Diabetes, Gastric Banding

In brief

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.

Key facts

Study ID

NCT01597531

Run by

East Carolina University

People needed

1

Starts

2012-06-01

Expected to finish

2014-06-01

Last updated by the study team

2018-02-05

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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