Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
H.pylori eradication
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Steatohepatitis,, Helicobacter pylori,, Insulin resistance,, Alanine aminotransferase,, Aspartate aminotransferase,
Eligibility Criteria
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.
Sites / Locations
- Gastroenterology clinic, Sina hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Lifestyle modification
H.pylori eradication
Arm Description
Obtaining ideal body weight by calorie restriction diet and programmed physical activity
H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Outcomes
Primary Outcome Measures
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)"
Secondary Outcome Measures
Serum Alanine Aminotransferase Level
Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study
Serum Aspartate Aminotransferase Level
Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study
Fasting Serum Glucose
Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study
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
Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Secondary outcome measure was change in HOMA-IR from baseline to the end of study
Anthropometric Measurements
Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study
Full Information
NCT ID
NCT01654549
First Posted
July 27, 2012
Last Updated
April 26, 2018
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01654549
Brief Title
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
Official Title
The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-diabetic Subjects With Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Steatohepatitis,, Helicobacter pylori,, Insulin resistance,, Alanine aminotransferase,, Aspartate aminotransferase,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle modification
Arm Type
No Intervention
Arm Description
Obtaining ideal body weight by calorie restriction diet and programmed physical activity
Arm Title
H.pylori eradication
Arm Type
Experimental
Arm Description
H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Intervention Type
Drug
Intervention Name(s)
H.pylori eradication
Other Intervention Name(s)
H.pylori treatment
Intervention Description
Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
Primary Outcome Measure Information:
Title
Liver Fat Content
Description
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)
Secondary Outcome Measure Information:
Title
Serum Alanine Aminotransferase Level
Description
Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study
Time Frame
8 weeks
Title
Serum Aspartate Aminotransferase Level
Description
Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study
Time Frame
8 weeks
Title
Fasting Serum Glucose
Description
Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study
Time Frame
8 weeks
Title
Serum Lipid Profile
Description
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
Title
Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Description
Secondary outcome measure was change in HOMA-IR from baseline to the end of study
Time Frame
8 weeks
Title
Anthropometric Measurements
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raika Jamali, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology clinic, Sina hospital.
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
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