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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01712711
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : May 6, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Raika Jamali, MD, Tehran University of Medical Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Non-alcoholic Fatty Liver Disease
Intervention Drug: H.pylori eradication
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lifestyle Modification H.Pylori Eradication
Hide Arm/Group 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
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Lifestyle Modification H.Pylori Eradication Total
Hide Arm/Group 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 Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
39.95  (9.53) 45.73  (12.54) 42.84  (11.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
8
  40.0%
12
  60.0%
20
  50.0%
Male
12
  60.0%
8
  40.0%
20
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iran, Islamic Republic of Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment
Hide Description 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)
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lifestyle Modification H.Pylori Eradication
Hide Arm/Group 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
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percentage of liver fat content
2.46  (2.23) 3.61  (3.25)
Time Frame 1 year
Adverse Event Reporting Description self-reporting by participants
 
Arm/Group Title Lifestyle Modification H.Pylori Eradication
Hide Arm/Group 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
All-Cause Mortality
Lifestyle Modification H.Pylori Eradication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lifestyle Modification H.Pylori Eradication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lifestyle Modification H.Pylori Eradication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Professor Raika Jamali
Organization: Tehran University of Medical Sciences
Phone: 00982163120000 ext 411
Responsible Party: Raika Jamali, MD, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01712711     History of Changes
Other Study ID Numbers: 1391/7/24-579
First Submitted: October 19, 2012
First Posted: October 23, 2012
Results First Submitted: March 21, 2013
Results First Posted: May 6, 2013
Last Update Posted: June 28, 2018