Phase 2
N=40
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01712711 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment — 2.46; 3.61 percentage of liver fat content
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- H.pylori eradication (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tehran University of Medical Sciences
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment |
2.46; 3.61 | — |
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 diabetic subjects with non-alcoholic fatty liver disease.
Eligibility Criteria
Inclusion Criteria
- Diabetic 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.
Data sourced from ClinicalTrials.gov (NCT01712711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.