Non-alcoholic Fatty Liver Disease
Conditions
Keywords
Steatohepatitis,, Helicobacter pylori,, Insulin resistance,, Alanine aminotransferase,, Aspartate aminotransferase,
Brief summary
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.
Detailed description
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.
Interventions
Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Dyspeptic patients with positive antibody to H.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
Exclusion criteria
* Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), diabetes mellitus, heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of \> 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any medication during the past 3 months, previous history of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Fat Content | 8 weeks (6 weeks post-treatment) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Aspartate Aminotransferase Level | 8 weeks | Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study |
| Fasting Serum Glucose | 8 weeks | Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study |
| Serum Alanine Aminotransferase Level | 8 weeks | Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study |
| Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) | 8 weeks | Secondary outcome measure was change in HOMA-IR from baseline to the end of study |
| Anthropometric Measurements | 8 weeks | Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study |
| Serum Lipid Profile | 8 weeks | 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 |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Modification Obtaining ideal body weight by calorie restriction diet and programmed physical activity | 20 |
| 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 | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | H.pylori eradication not successful | 0 | 1 |
Baseline characteristics
| Characteristic | H.Pylori Eradication | Lifestyle Modification | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 41.11 years STANDARD_DEVIATION 10.14 | 42.90 years STANDARD_DEVIATION 13.96 | 41.57 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment Iran, Islamic Republic of | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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)
Time frame: 8 weeks (6 weeks post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liver Fat Content in H.Pylori Eradication at Baseline | Liver Fat Content | 8.38 percentage of liver fat content | Standard Deviation 4.47 |
| Liver Fat Content in H.Pylori Eradication at 8 Weeks | Liver Fat Content | 7.72 percentage of liver fat content | Standard Deviation 4.34 |
| Liver Fat Content in Lifestyle Modification at Baseline | Liver Fat Content | 8.50 percentage of liver fat content | Standard Deviation 6.03 |
| Liver Fat Content in Lifestyle Modification at 8 Weeks | Liver Fat Content | 7.29 percentage of liver fat content | Standard Deviation 5.06 |
| Liver Fat Content Change in H.Pylori Eradication | Liver Fat Content | 0.66 percentage of liver fat content | Standard Deviation 0.61 |
| Liver Fat Content Change in Lifestyle Modification | Liver Fat Content | 1.21 percentage of liver fat content | Standard Deviation 1.31 |
p-value: 0.94t-test, 2 sided
p-value: 0.78t-test, 2 sided
p-value: <0.01Paired t-test
p-value: <0.01Paired t-test
p-value: 0.1t-test, 2 sided
Secondary
Anthropometric Measurements
Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study
Time frame: 8 weeks
Secondary
Fasting Serum Glucose
Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study
Time frame: 8 weeks
Secondary
Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Secondary outcome measure was change in HOMA-IR from baseline to the end of study
Time frame: 8 weeks
Secondary
Serum Alanine Aminotransferase Level
Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study
Time frame: 8 weeks
Secondary
Serum Aspartate Aminotransferase Level
Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study
Time frame: 8 weeks
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
Time frame: 8 weeks