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Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT01654549
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : December 21, 2012
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 19
Not Completed 0 1
Reason Not Completed
H.pylori eradication not successful             0             1
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
42.90  (13.96) 41.11  (10.14) 41.57  (12.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
9
  45.0%
11
  55.0%
20
  50.0%
Male
11
  55.0%
9
  45.0%
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
Hide Description

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)”

Time Frame 8 weeks (6 weeks post-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Fat Content in H.Pylori Eradication at Baseline Liver Fat Content in H.Pylori Eradication at 8 Weeks Liver Fat Content in Lifestyle Modification at Baseline Liver Fat Content in Lifestyle Modification at 8 Weeks Liver Fat Content Change in H.Pylori Eradication Liver Fat Content Change in Lifestyle Modification
Hide Arm/Group Description:
Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline
Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks
Liver fat content in lifestyle modification group at baseline
Liver fat content in lifestyle modification group at 8 weeks
The change of liver fat content from baseline to the end of study in H.pylori eradication group
The change of liver fat content from baseline to the end of study in lifestyle modification group
Overall Number of Participants Analyzed 19 19 20 20 19 20
Mean (Standard Deviation)
Unit of Measure: percentage of liver fat content
8.38  (4.47) 7.72  (4.34) 8.50  (6.03) 7.29  (5.06) 0.66  (0.61) 1.21  (1.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liver Fat Content in H.Pylori Eradication at Baseline, Liver Fat Content in Lifestyle Modification at Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liver Fat Content in H.Pylori Eradication at 8 Weeks, Liver Fat Content in Lifestyle Modification at 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liver Fat Content in H.Pylori Eradication at Baseline, Liver Fat Content in H.Pylori Eradication at 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Liver Fat Content in Lifestyle Modification at Baseline, Liver Fat Content in Lifestyle Modification at 8 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Liver Fat Content Change in H.Pylori Eradication, Liver Fat Content Change in Lifestyle Modification
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Serum Alanine Aminotransferase Level
Time Frame 8 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Serum Aspartate Aminotransferase Level
Time Frame 8 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Fasting Serum Glucose
Hide Description Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study
Time Frame 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Serum Lipid Profile
Hide Description Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study
Time Frame 8 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Hide Description Secondary outcome measure was change in HOMA-IR from baseline to the end of study
Time Frame 8 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Anthropometric Measurements
Hide Description Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study
Time Frame 8 weeks
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description self-reporting by participants
 
Arm/Group Title H. Pylori Eradication No Intervention
Hide Arm/Group Description Helicobacter pylori eradication Lifestyle modification
All-Cause Mortality
H. Pylori Eradication No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
H. Pylori Eradication No Intervention
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%
H. Pylori Eradication No Intervention
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: Dr Raika Jamali
Organization: Tehran University of Medical Sciences
Phone: 982163120000 ext 411
Responsible Party: Raika Jamali, MD, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01654549     History of Changes
Other Study ID Numbers: 1391/3/27-573
First Submitted: July 27, 2012
First Posted: July 31, 2012
Results First Submitted: October 20, 2012
Results First Posted: December 21, 2012
Last Update Posted: June 28, 2018