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The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.
This randomized double blind clinical trial was performed in non-diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle modification | No Intervention | Obtaining ideal body weight by calorie restriction diet and programmed physical activity | |
| H.pylori eradication | Experimental | H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H.pylori eradication | Drug | Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Fat Content | Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment). The percent of liver fat was calculated as below: "Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)" | 8 weeks (6 weeks post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Alanine Aminotransferase Level | Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study | 8 weeks |
| Serum Aspartate Aminotransferase Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raika Jamali, M.D. | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology clinic, Sina hospital. | Tehran | Iran |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Modification | Obtaining ideal body weight by calorie restriction diet and programmed physical activity |
| FG001 | H.Pylori Eradication | H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Modification | Obtaining ideal body weight by calorie restriction diet and programmed physical activity |
| BG001 | H.Pylori Eradication | H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity |
| 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 | Liver Fat Content | Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment). The percent of liver fat was calculated as below: "Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)" | Posted | Mean | Standard Deviation | percentage of liver fat content | 8 weeks (6 weeks post-treatment) |
|
1 year
self-reporting by participants
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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 | H. Pylori Eradication | Helicobacter pylori eradication |
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No limitations and Caveats
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Raika Jamali | Tehran University of Medical Sciences | 982163120000 | 411 | jamalira@tums.ac.ir |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study
| 8 weeks |
| Fasting Serum Glucose | Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study | 8 weeks |
| Serum Lipid Profile | Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study | 8 weeks |
| Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) | Secondary outcome measure was change in HOMA-IR from baseline to the end of study | 8 weeks |
| Anthropometric Measurements | Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks |
| OG002 | Liver Fat Content in Lifestyle Modification at Baseline | Liver fat content in lifestyle modification group at baseline |
| OG003 | Liver Fat Content in Lifestyle Modification at 8 Weeks | Liver fat content in lifestyle modification group at 8 weeks |
| OG004 | Liver Fat Content Change in H.Pylori Eradication | The change of liver fat content from baseline to the end of study in H.pylori eradication group |
| OG005 | Liver Fat Content Change in Lifestyle Modification | The change of liver fat content from baseline to the end of study in lifestyle modification group |
|
|
|
| Secondary | Serum Alanine Aminotransferase Level | Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study | Not Posted | 8 weeks | Participants |
| Secondary | Serum Aspartate Aminotransferase Level | Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study | Not Posted | 8 weeks | Participants |
| Secondary | Fasting Serum Glucose | Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study | Not Posted | 8 weeks | Participants |
| Secondary | Serum Lipid Profile | Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study | Not Posted | 8 weeks | Participants |
| Secondary | Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) | Secondary outcome measure was change in HOMA-IR from baseline to the end of study | Not Posted | 8 weeks | Participants |
| Secondary | Anthropometric Measurements | Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study | Not Posted | 8 weeks | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | No Intervention | Lifestyle modification | 0 | 20 | 0 | 20 |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |