Trials Sponsors Conditions Drugs Pricing

Conditions

Fatty Liver Insulin Resistance Liver Dysfunction

Keywords

SteatohepatitisHelicobacter pyloriAlanine aminotransferaseAspartate aminotransferaseFatty LiverLiver DiseasesDigestive System Diseases

Outcome Measures

Primary Outcomes (1)

Change from baseline liver fat content at 6 months
6 months

Secondary Outcomes (1)

Change from baseline liver function tests at 6 months
6 months

Other Outcomes (1)

Change from baseline insulin resistance at 6 months
6 months

Study Arms (2)

H.pylori eradication

EXPERIMENTAL

H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Drug: H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)

Lifestyle modification

NO INTERVENTION

Obtaining ideal body weight by calorie restriction diet and programmed physical activity

Interventions

H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)Drug

The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks.

Also known as: H.pylori treatment

H.pylori eradication

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Tehran University of Medical Sciences
Otherlead

Study Sites (1)

Gastroenterology clinic, Sina Hospital

Tehran, Tehran Province, Iran

MeSH Terms

Conditions

Fatty LiverLiver DiseasesInsulin ResistanceDigestive System Diseases

Interventions

OmeprazoleAmoxicillinbismuth tripotassium dicitrateAzithromycin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles

Study Officials

Raika Jamali, M.D.
Tehran University of Medical Sciences
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor of Medicine

Study Record Dates

First Submitted

June 8, 2013

First Posted

June 12, 2013

Study Start

July 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2013

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

H.pylori eradication

Lifestyle modification

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

H.pylori eradication

Lifestyle modification

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations