Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063232
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2003-06-23
Brief Title:
Treating Nonalcoholic Steatohepatitis NASH With Metformin
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Nonalcoholic Steatohepatitis With Metformin
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
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:
Nonalcoholic Steatohepatitis NASH is associated with progressive liver disease fibrosis and cirrhosis Although the cause of NASH is unknown it is often associated with obesity type 2 diabetes and insulin resistance At present there are no approved treatments for NASH patients but an experimental approach has focused on improving their insulin sensitivity Metformin is one of the most commonly used medications for the treatment of diabetes
The purpose of this study is to determine whether the medical problems of NASH patients specifically liver damage improves when their insulin sensitivity is enhanced with metformin
The study will last 3 to 5 years and will enroll up to 30 patients Participants will undergo a complete medical examination a series of lab tests and a liver biopsy They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks then the same dosage twice a day for 2 more weeks if they tolerate the first dosage The dosage will increase to 1000 mg twice a day for the remaining 44 weeks of the study After 1 year participants will undergo a repeat medical examination and liver biopsy
The purpose of this study is to determine whether the medical problems of NASH patients specifically liver damage improves when their insulin sensitivity is enhanced with metformin
The study will last 3 to 5 years and will enroll up to 30 patients Participants will undergo a complete medical examination a series of lab tests and a liver biopsy They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks then the same dosage twice a day for 2 more weeks if they tolerate the first dosage The dosage will increase to 1000 mg twice a day for the remaining 44 weeks of the study After 1 year participants will undergo a repeat medical examination and liver biopsy
Detailed Description:
Nonalcoholic fatty liver disease NAFLD represents a spectrum of diseases ranging from simple fatty liver steatosis to steatosis with inflammation and necrosis to cirrhosis that occurs in persons who drink little or no alcohol Nonalcoholic steatohepatitis NASH represents the more severe end of this spectrum and is associated with progressive liver disease fibrosis and cirrhosis The etiology of NASH is unclear but it is often associated with obesity type 2 diabetes hyperlipidemia and insulin resistance We have recently conducted a study of a 48-week course of pioglitazone in 21 non-diabetic patients with NASH Serum aminotransferase levels and liver histology improved in most patients and the improvements correlated with changes in insulin sensitivity These results are promising but pioglitazone is associated with significant weight gain is quite expensive and its long-term safety is yet to be proven In contrast metformin is inexpensive extremely well tolerated and of proven long-term safety in patients with diabetes and pre-diabetes
In this study we propose to treat 20 non-diabetic patients with NASH with metformin for 48-weeks After an initial evaluation for insulin sensitivity fat distribution and liver biopsy patients will receive gradually increasing doses of metformin orally to a maximum of 2000 mg daily Patients will be monitored at regular intervals for symptoms of liver disease side effects of metformin and serum biochemical and metabolic indices At the end of 48-weeks patients will have a repeat medical evaluation and liver biopsy Pre and post treatment liver histology fat distribution and insulin sensitivity will be compared The primary end point of successful therapy will be improvement in hepatic histology as determined by reduction of at least three points in NASH activity score Secondary end points will be improvement in insulin sensitivity body fat distribution and liver biochemistry
In this study we propose to treat 20 non-diabetic patients with NASH with metformin for 48-weeks After an initial evaluation for insulin sensitivity fat distribution and liver biopsy patients will receive gradually increasing doses of metformin orally to a maximum of 2000 mg daily Patients will be monitored at regular intervals for symptoms of liver disease side effects of metformin and serum biochemical and metabolic indices At the end of 48-weeks patients will have a repeat medical evaluation and liver biopsy Pre and post treatment liver histology fat distribution and insulin sensitivity will be compared The primary end point of successful therapy will be improvement in hepatic histology as determined by reduction of at least three points in NASH activity score Secondary end points will be improvement in insulin sensitivity body fat distribution and liver biochemistry
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-DK-0233 | None | None | None |