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Treating Nonalcoholic Steatohepatitis (NASH) With Metformin
This study has been completed.
Study NCT00063232   Information provided by National Institutes of Health Clinical Center (CC)

First Received on June 23, 2003.   Last Updated on June 21, 2011   History of Changes
Results First Received: March 14, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis
Intervention: Drug: Metformin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
28 adult patients with biopsy-proven NASH were enrolled in the study and 26 completed the 48 weeks of therapy and underwent follow-up metabolic testing, imaging and repeat liver biopsy. 2 patients dropped out were not included in analyses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The two drop-outs included a 26-year-old woman who stopped therapy after 12 weeks because she had moved and her employment did not allow time for travel for outpatient visits and a 53-year-old woman who stopped therapy after 24 weeks because of desire to pursue other treatments.

Reporting Groups
  Description
Metformin 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 1,000 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.

Participant Flow:   Overall Study
    Metformin  
STARTED     26  
COMPLETED     26  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Metformin 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 1,000 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.

Baseline Measures
    Metformin  
Number of Participants  
[units: participants]
 		  26  
Age  
[units: years]
Mean ± Standard Deviation 		  44  ± 14  
Gender  
[units: participants]
 		 
Female     13  
Male     13  
Race/Ethnicity, Customized  
[units: participants]
 		 
Non-Hispanic White     17  
Hispanic White     4  
Asian     5  
African-American     0  
Region of Enrollment  
[units: participants]
 		 
United States     26  
Body Mass Index  
[units: participants]
 		 
Overweight (BMI=25-30 kg/m^2)     8  
Obese (BMI=30-40 kg/m^2)     13  
Severely Obese (BMI greater than 40 kg/m^2)     5  
Glucose tolerance [1]
[units: partcipants]
 		 
impaired     8  
not impaired     18  
Diabetes [2]
[units: participants]
 		 
Yes     7  
No     19  
[1] Impaired glucose tolerance is defined by fasting glucose 110–125 or >=160 mg⁄ dL after 2-h glucose load
[2] Diabetes is defined by a fasting glucose greater or equal to 125 or greater or equal to 200 mg per dL aftera 2-h glucose load.



  Outcome Measures
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1.  Primary:   Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category)   [ Time Frame: from baseline to 48 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category)   [ Time Frame: from baseline to 48 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline   [ Time Frame: from baseline to 48 weeks ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jay Hoofnagle, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases
phone: 3014961333
e-mail: hoofnaglej@extra.niddk.nih.gov


Publications:
Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9.

Publications automatically indexed to this study:
Loomba R, Lutchman G, Kleiner DE, Ricks M, Feld JJ, Borg BB, Modi A, Nagabhyru P, Sumner AE, Liang TJ, Hoofnagle JH. Clinical trial: pilot study of metformin for the treatment of non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2009 Jan;29(2):172-82. Epub 2008 Oct 9.


Responsible Party: Jay Hoofnagle, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00063232     History of Changes
Other Study ID Numbers: 030233, 03-DK-0233
Study First Received: June 23, 2003
Results First Received: March 14, 2011
Last Updated: June 21, 2011
Health Authority: United States: Federal Government





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