| Trial ID: | L0340 |
| Source ID: | NCT01260246
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes
|
| Acronym: |
--
|
| Status: |
Terminated
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes|Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: sitagliptin|Drug: placebo
|
| Outcome Measures: |
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.|In individuals with NASH and DM2: To document the impact of sitagliptin therapy on adipocytokines, inflammatory markers, non-traditional cardiovascular risk factors, adipose distribution, and dyslipidemia.|In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress.|In individuals with NASH and DM2: To determine the correlation between changes in histology with changes in hepatic fat demonstrated by MRI and changes in fibrosis by Fibroscan.
|
| Sponsor/Collaborators: |
Lawson Health Research Institute|The Physicians' Services Incorporated Foundation
|
| Gender: |
All
|
| Age: |
18 Years to 100 Years ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
12
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
December 2010
|
| Completion Date: |
April 2015
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 14, 2017
|
| Locations: |
St. Joseph's Health Care, London, Ontario, Canada
|
| URL: |
https://ClinicalTrials.gov/show/NCT01260246
|
