Status:
WITHDRAWN
Evaluation of the DPP-4 Inhibitor Sitagliptin in the Treatment of Non-Alcoholic Fatty Liver Disease Using MRI
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Type 2 Diabetes
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Participants will be persons with type 2 diabetes who are likely to have fatty liver disease. The investigators think that this medication will reduce fatty liver. The investigators will use an MRS (...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) and its progression to non-alcoholic steatohepatitis (NASH) and finally cirrhosis is rapidly becoming the leading cause of liver injury and end stage liver di...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus with hemoglobin A1c above 6.5%.
- Waist circumference over 40 inches in a male or 35 inches in a female or BMI greater than 30.
- Age between 18 and 70 years.
- Stable on maximum tolerated dose of metformin for at least 3 months prior to enrollment.
- Sedentary (less than 30 minutes per week of structured activity) and weight stable (2% body weight in past 6 months).
- Metabolic syndrome based on NCEP ATP-3 guidelines with diabetes accepted as the glycemic component.
- For women: at least 2 years postmenopausal, surgically sterile, or using an acceptable contraceptive regimen to include OCP, IUD, double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start.
- For men: surgically sterile or agreement that any female partner meet criteria of 7.
Exclusion
- Pregnancy, breast feeding, or planning to become pregnant during the study period.
- GFR less than 60mL per minute per meter squared.
- Any medical condition expected to be terminal within one year.
- Cirrhosis of any cause or liver disease due to auto-immune, infectious or alcohol induced hepatitis.
- Active mental illness or other condition which in the opinion of the investigator would prevent informed consent or compliance with study protocol.
- Use of PPAR agonist within six months prior to enrollment.
- Daily insulin use.
- Allergy or intolerance of sitagliptin or other DPP-4 inhibitor.
- Use of DPP-4 inhibitor, bile acid sequesterant, or weight loss medications within three months prior to enrollment.
- Significant alcohol use defined as greater than 21 standard servings of alcohol (10gms) per week for men and greater than 14 for women.
- History of bariatric surgery or planned bariatric surgery during the study period.
- Weight, girth, or other factor preventing MRI scanning.
- Receipt of another study drug within 30 days of screening.
- Unable to receive a DEXA scan due to participating in research study or medical procedure involving ionizing radiation exposure equivalent to a chest x-ray or greater in the past 12 months.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02263677
Start Date
March 1 2014
End Date
January 1 2016
Last Update
October 5 2016
Active Locations (1)
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1
University of Missouri-Columbia: Diabetes Center
Columbia, Missouri, United States, 65212