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Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) (NAFLD)

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ClinicalTrials.gov Identifier: NCT00736385
Recruitment Status : Terminated
First Posted : August 15, 2008
Results First Posted : March 26, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Manal Abdelmalek, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fatty Liver
Interventions Drug: Glucophage (Metformin)
Drug: Placebo
Enrollment 11
Recruitment Details 11 subjects signed consent to participate. 2 subjects were screen failures. 9 subjects were randomized.
Pre-assignment Details  
Arm/Group Title Metformin Placebo
Hide Arm/Group Description

Metformin XR (extended-release) 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

Period Title: Overall Study
Started 4 5
Completed 2 2
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             2             2
Adverse Event             0             1
Arm/Group Title Metformin Placebo Total
Hide Arm/Group Description

Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
  80.0%
8
  88.9%
>=65 years
0
   0.0%
1
  20.0%
1
  11.1%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
0
   0.0%
2
  40.0%
2
  22.2%
Male
4
 100.0%
3
  60.0%
7
  77.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
5
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:

Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:

Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:

Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:

Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Placebo
Hide Arm/Group Description

Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months

Placebo capsule

Placebo: placebo 2000 mg daily for 12 months

All-Cause Mortality
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      2/5 (40.00%)    
Cardiac disorders     
Bradycardia Syndrome  0/4 (0.00%)  0 1/5 (20.00%)  1
Reproductive system and breast disorders     
Ovarian Cyst  0/4 (0.00%)  0 1/5 (20.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      5/5 (100.00%)    
Cardiac disorders     
atrial fibrillation  0/4 (0.00%)  1/5 (20.00%) 
Eye disorders     
bluriness of vision  0/4 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders     
Stomach cramping, diarrhea and vomitting  2/4 (50.00%)  0/5 (0.00%) 
Infections and infestations     
Sinus headache, sinus infection, cold  1/4 (25.00%)  2/5 (40.00%) 
Tooth pain  0/4 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders     
Vitamin B12 deficiency  1/4 (25.00%)  0/5 (0.00%) 
vitamin D deficiency  1/4 (25.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain, low back pain  1/4 (25.00%)  1/5 (20.00%) 
arthritis (shoulder and neck ) [1]  0/4 (0.00%)  1/5 (20.00%) 
Psychiatric disorders     
Low energy and low mood  0/4 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders     
gross bloody urine-renal stone  0/4 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders     
Rash and itching or redness  0/4 (0.00%)  2/5 (40.00%) 
Surgical and medical procedures     
Cut wound  1/4 (25.00%)  0/5 (0.00%) 
[1]
x-ray diagnosed shoulder and neck arthritis
Study was terminated early due to difficulties with enrollment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Christopher Kigongo
Organization: Duke University Medical Center
Phone: 919-668-6579
Responsible Party: Manal Abdelmalek, Duke University
ClinicalTrials.gov Identifier: NCT00736385     History of Changes
Other Study ID Numbers: Pro00006196
K23DK062116 ( U.S. NIH Grant/Contract )
First Submitted: August 13, 2008
First Posted: August 15, 2008
Results First Submitted: March 17, 2015
Results First Posted: March 26, 2015
Last Update Posted: December 7, 2016