Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease

NCT01712711 | Completed Phase 2 Results

• 1 other identifier: 1391/7/24-579
• 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 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 Change From Baseline to Six Weeks Post H.Pylori Treatment

  Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 \* metabolic syndrome (yes = 11 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)

  baseline and 6 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

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: Helicobacter 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:

• 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

You may not qualify if:

• 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.

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 limitation existed.

Results Point of Contact

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

jamalira@tums.ac.ir

00982163120000

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: October 19, 2012
• First Posted: October 23, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 28, 2018
• Results First Posted: May 6, 2013

Record last verified: 2018-04

Locations

IR (1)