Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

NCT01654549 | Completed Phase 2 Results

• 1 other identifier: 1391/3/27-573
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,

Outcome Measures

Primary Outcomes (1)

• 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)"

  8 weeks (6 weeks post-treatment)

Secondary Outcomes (6)

• Serum Alanine Aminotransferase Level

  8 weeks

• Serum Aspartate Aminotransferase Level

  8 weeks

• Fasting Serum Glucose

  8 weeks

• Serum Lipid Profile

  8 weeks

• Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)

  8 weeks

Study Arms (2)

Lifestyle modification

NO INTERVENTION

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

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

Interventions

H.pylori eradication DRUG

Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)

Also known as: H.pylori treatment

H.pylori eradication

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Gastroenterology clinic, Sina hospital.

Tehran, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Insulin Resistance

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

No limitations and Caveats

Results Point of Contact

• Title: Dr Raika Jamali
• Organization: Tehran University of Medical Sciences

jamalira@tums.ac.ir

982163120000

Study Officials

• Raika Jamali, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 27, 2012
• First Posted: July 31, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 28, 2018
• Results First Posted: December 21, 2012

Record last verified: 2018-04

Locations

IR (1)