Fatty Liver, Insulin Resistance, Liver Dysfunction
Conditions
Keywords
Steatohepatitis, Helicobacter pylori, Alanine aminotransferase, Aspartate aminotransferase, Fatty Liver, Liver Diseases, Digestive System Diseases
Brief summary
The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.
Detailed description
This randomized double blind clinical trial was performed in 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,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.
Interventions
DRUGH.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)
The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks.
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 No maximum
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), * 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 hepatotoxic 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 |
|---|---|
| Change from baseline liver fat content at 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline liver function tests at 6 months | 6 months |
Other
| Measure | Time frame |
|---|---|
| Change from baseline insulin resistance at 6 months | 6 months |
Countries
Iran
Outcome results
None listed