Trial Outcomes & Findings for Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease (NCT NCT01712711)

Last Updated: 2018-06-28

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

baseline and 6 weeks

Results posted on

2018-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lifestyle Modification Obtaining ideal body weight by calorie restriction diet and programmed physical activity	H.Pylori Eradication H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Modification n=20 Participants Obtaining ideal body weight by calorie restriction diet and programmed physical activity	H.Pylori Eradication n=20 Participants H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.95 years STANDARD_DEVIATION 9.53 • n=5 Participants	45.73 years STANDARD_DEVIATION 12.54 • n=7 Participants	42.84 years STANDARD_DEVIATION 11.04 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks

Outcome measures

Outcome measures
Measure	Lifestyle Modification n=20 Participants Obtaining ideal body weight by calorie restriction diet and programmed physical activity	H.Pylori Eradication n=20 Participants H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment	2.46 percentage of liver fat content Standard Deviation 2.23	3.61 percentage of liver fat content Standard Deviation 3.25

Adverse Events

Lifestyle Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

H.Pylori Eradication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Raika Jamali

Tehran University of Medical Sciences

Phone: 00982163120000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place