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Trial record 14 of 357 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01876108
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Raika Jamali, MD, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE June 8, 2013
First Posted Date  ICMJE June 12, 2013
Last Update Posted Date July 8, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
Change from baseline liver fat content at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
Change of liver fat content [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01876108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
Change from baseline liver function tests at 6 months [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
Change of liver function tests [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: June 12, 2013)
Change from baseline insulin resistance at 6 months [ Time Frame: 6 months ]
Original Other Pre-specified Outcome Measures
 (submitted: June 11, 2013)
Change of insulin resistance [ Time Frame: 6 months ]
 
Descriptive Information
Brief Title  ICMJE The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease
Official Title  ICMJE The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Subjects With Non-alcoholic Fatty Liver Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fatty Liver
  • Liver Dysfunction
  • Insulin Resistance
Intervention  ICMJE Drug: H.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.
Other Name: H.pylori treatment
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)
  • No Intervention: Lifestyle modification
    Obtaining ideal body weight by calorie restriction diet and programmed physical activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 11, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01876108
Other Study ID Numbers  ICMJE 1392/3/11- 589
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raika Jamali, MD, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raika Jamali, M.D. Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP