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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK062116 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to find out if Metformin is safe and useful in the treatment of NAFLD.
NAFLD is a poorly understood disease which may cause an enlarged liver, abnormal liver test results, and scarring of the liver. It may occur more often in people with obesity, high levels of cholesterol (blood fats), diabetes (high blood sugar), or the insulin resistance syndrome (where a person's body does not respond to the hormone insulin which helps keep blood sugar levels normal). Currently, no effective drug treatment for NAFLD exists. There is increasing evidence that NAFLD may be a condition due to a problem with metabolism (the way your body uses energy). Previous studies have shown that high glucose (sugar) levels may play an important role in the development of fatty liver disease. Medications that decrease your natural glucose level may reduce the amount of fat in the liver and, therefore, might be useful in the treatment of NAFLD. Metformin, a drug approved by the U.S. Food and Drug Administration (FDA) for use in patients with diabetes, has been shown to improve fatty liver in animals and in a small number of human beings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin XR (extended-release) 2000 mg daily |
|
| Placebo | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucophage (Metformin) | Drug | metformin XR 2000 mg daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months | |
| Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manal F Abdelmalek, MD, MPH | Duke University Medical Center, Department of Medicine, Division of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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11 subjects signed consent to participate. 2 subjects were screen failures. 9 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Metformin XR (extended-release) 2000 mg daily Glucophage (Metformin): metformin XR 2000 mg daily for 12 months |
| FG001 | Placebo | Placebo capsule Placebo: placebo 2000 mg daily for 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Metformin XR 2000 mg daily Glucophage (Metformin): metformin XR 2000 mg daily for 12 months |
| BG001 | Placebo | Placebo capsule Placebo: placebo 2000 mg daily for 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study was terminated early due to difficulties with enrollment. No outcome measures were assessed. | Posted | 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | Metformin XR 2000 mg daily Glucophage (Metformin): metformin XR 2000 mg daily for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian Cyst | Reproductive system and breast disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck pain, low back pain | Musculoskeletal and connective tissue disorders |
Study was terminated early due to difficulties with enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kigongo | Duke University Medical Center | 919-668-6579 | christopher.kigongo@duke.edu |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | placebo 2000 mg daily for 12 months |
|
| 24 months |
| 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 | 24 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | 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. | Study was terminated early due to difficulties with enrollment. No outcome measures were assessed. | Posted | 24 months |
|
|
| Secondary | Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo. | Study was terminated early due to difficulties with enrollment. No outcome measures were assessed. | Posted | 24 months |
|
|
| Secondary | 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 | Study was terminated early due to difficulties with enrollment. No outcome measures were assessed. | Posted | 24 months |
|
|
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Placebo | Placebo capsule Placebo: placebo 2000 mg daily for 12 months | 2 | 5 | 5 | 5 |
| Bradycardia Syndrome | Cardiac disorders |
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| arthritis (shoulder and neck ) | Musculoskeletal and connective tissue disorders | x-ray diagnosed shoulder and neck arthritis |
|
| Sinus headache, sinus infection, cold | Infections and infestations |
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| Rash and itching or redness | Skin and subcutaneous tissue disorders |
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| Stomach cramping, diarrhea and vomitting | Gastrointestinal disorders |
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| bluriness of vision | Eye disorders |
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| Low energy and low mood | Psychiatric disorders |
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| atrial fibrillation | Cardiac disorders |
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| Tooth pain | Infections and infestations |
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| gross bloody urine-renal stone | Renal and urinary disorders |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders |
|
| vitamin D deficiency | Metabolism and nutrition disorders |
|
| Cut wound | Surgical and medical procedures |
|
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