Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247117
Status:
UNKNOWN
Last Update Posted:
2006-10-09
First Post:
2005-10-31
Brief Title:
Metformin in Patients With Non-Alcoholic Fatty Liver Disease NAFLD
Sponsor:
Kaplan Medical Center
Organization:
Kaplan Medical Center
Study Overview
Official Title:
Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome
Detailed Description:
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 gweek
All patients will undergo liver biopsy and only patients with type 2-4 steatosis inflammation or steatosis plus ballooning degeneration or steatosis plus fibrosis andor 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prior to study will continue the treatment Patients who will develop overt type 2 DM with HbAic 7 during study will be withdrawn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
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 gweek
All patients will undergo liver biopsy and only patients with type 2-4 steatosis inflammation or steatosis plus ballooning degeneration or steatosis plus fibrosis andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None