| Trial ID: | L5898 |
| 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: |
|
| Conditions: |
Type 2 Diabetes|Nonalcoholic Steatohepatitis
|
| Interventions: |
DRUG: sitagliptin|DRUG: placebo
|
| Outcome Measures: |
Primary: To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin., 3 years | Secondary: 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., 3 years|In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress., 3 years|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., 3 years
|
| Sponsor/Collaborators: |
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Collaborators: The Physicians' Services Incorporated Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-12
|
| Completion Date: |
2015-04
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-14
|
| Locations: |
St. Joseph's Health Care, London, Ontario, N6A 4L6, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01260246
|
