| Trial ID: | L0071 |
| Source ID: | NCT00736385
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
|
| Acronym: |
NAFLD
|
| Status: |
Terminated
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT00736385/results
|
| Conditions: |
Fatty Liver
|
| Interventions: |
Drug: Glucophage (Metformin)|Drug: Placebo
|
| Outcome Measures: |
Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.|Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.|Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.|Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress
|
| Sponsor/Collaborators: |
Manal Abdelmalek|Duke University
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
11
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
April 2009
|
| Completion Date: |
December 2012
|
| Results First Posted: |
March 26, 2015
|
| Last Update Posted: |
December 7, 2016
|
| Locations: |
Duke University Medical Center, Durham, North Carolina, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00736385
|
