| Trial ID: | L3202 |
| Source ID: | NCT02457286
|
| Associated Drug: |
Metformin
|
| Title: |
Improving Insulin Resistance To Treat Non-Alcoholic Fatty Liver Disease: A Pilot Study
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Non-alcoholic Fatty Liver Disease (NAFLD)
|
| Interventions: |
DRUG: Metformin|BEHAVIORAL: Lifestyle modifications|DEVICE: Fibroscan device (Echosens)
|
| Outcome Measures: |
Primary: Improvement in NAFLD as measured by ALT levels, The primary endpoint variable is the improvement in NAFLD after 12 months of treatment, as measured by the change in ALT levels from baseline to the end of a one year follow-up. A decrease of at least 25% from baseline will be considered a clinically relevant response., 12 Months | Secondary: Incidence of metabolic syndrome (insulin resistance), The study will be using measurements of BMI, waist circumference, blood pressure, lipids and fasting blood glucose levels to assess insulin resistance., 12 months|Incidence of NAFLD fibrosis scores after 12 months of treatment as measured by Fibroscan, A NAFLD Fibrosis Score (28), a noninvasive scoring system for liver fibrosis in patients with NAFLD, can be calculated and potentially used to assess for histologic improvement with metformin, which thus far has never been assessed., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Northwell Health
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-06
|
| Completion Date: |
2017-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-28
|
| Locations: |
North Shore Hospital, Manhasset, New York, 11030, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02457286
|
