Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Recruitment status was Recruiting
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Purpose
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.
| Condition | Intervention |
|---|---|
|
Liver Diseases |
Drug: Metformin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease |
- histological and biochemical changes
| Estimated Enrollment: | 15 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | August 2005 |
Study population:
30 patients will be included who meet all the following criteria: ALT > 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.
Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic > 7% during study will be withdrawn.
Intervention:
All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.
Outcome:
- Improvement of liver enzymes (ALT, AST, GGT)
- Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
- Liver histology (repeated liver biopsy after 1 year).
- Soluble TNF receptors- TNF-receptor P55 and P75.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ALT > 2 times normal range.
- Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), without cirrhosis.
- Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes.
- Negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
Exclusion Criteria:
- Diabetes mellitus.
- Alcohol intake > 40 g per week.
Contacts and Locations| Contact: Hila Knobler, MD | 08-9441650 | knobler@inter.net.il |
| Israel | |
| Institute of Endocrinology, Kaplan Medical Center | Recruiting |
| Rehovot, Israel, 76100 | |
| Study Director: | Stephen D Malnick, MD | Kaplan Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00247117 History of Changes |
| Other Study ID Numbers: | 037-2003 |
| Study First Received: | October 31, 2005 |
| Last Updated: | October 6, 2006 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Kaplan Medical Center:
|
non-alcoholic fatty liver disease insulin resistance metformin |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013