Determination of the efficacy of carnitine and pioglitazone in comparison with carnitine and metformin, in ultrasound and liver enzymes in patients with non-alcoholic fatty liver disease
Design
Patients will be randomly divided into two groups using carnitine and pioglitazone and carnitine and metformin recipients using the Excel program.
Sample size using G-power software and considering 90% power and 95% confidence level and probable 30% loss and using ALT results in the study of hong et al, In 2014, at least 30 individuals in each group and 60 persons in total were calculated and in this study 40 persons per group and 80 persons in total were selected.
Settings and conduct
This study performed in patients with non-alcoholic fatty liver who were randomly assigned to the intervention (carnitine and pioglitazone) and control groups (carnitine and metformin) in a 1: 1 ratio with the help of Excel. Patients admitted to the liver fatty clinic who have evidence of liver fever on ultrasound will be included or excluded from the study through inclusion and exclusion criteria and with informed consent.
Participants/Inclusion and exclusion criteria
Paitents with NAFLD who have been ruled out all known causes of fatty liver disease including alcohol, medications, viral hepatitis, autoimmune hepatitis and metabolic causes such as Wilson and hemochromatosis and etc.
Patients with liver disease such as viral hepatitis, autoimmune hepatitis, Wilson, hemochromatosis, liver cirrhosis, and PBC and PSC,Patients who drink alcohol.Patients with Creatinine > 1.5 mg/dl, Patients with known severe systemic disease and malignancy.Pregnancy or breastfeeding. type 1 diabetes
Intervention groups
Intervention group: carnitine (1000 mg daily) and pioglitazone (30mg daily) Control group: carnitine (1000 mg daily) and metformin (500 mg daily)
Main outcome variables
Ultrasound grade; AST serum level; ALT serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044062N3
Registration date:2020-09-16, 1399/06/26
Registration timing:registered_while_recruiting
Last update:2020-09-16, 1399/06/26
Update count:0
Registration date
2020-09-16, 1399/06/26
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the teraputic effect of pioglitazone and carnitine to metformin and carnitine in patients with non alcoholic fatty liver disease
Public title
comparison the teraputic effect of pioglitazone and carnitine to metformin and carnitine in patients with non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
17-50 years old
Paitents with non alcoholic fatty liver disease who have been ruled out all known causes of fatty liver disease including alcohol, medications, viral hepatitis, autoimmune hepatitis and metabolic causes such as Wilson and hemochromatosis and etc.
Exclusion criteria:
Patients with liver disease such as viral hepatitis, autoimmune hepatitis, Wilson, hemochromatosis, liver cirrhosis, and PBC and PSC
Patients who drink alcohol.
Patients with renal Failure ( Creatinine > 1.5 mg/dl)
Patients with known severe systemic disease and malignancy.
Pregnancy or breastfeeding
Patients with type 1 diabetes
Age
From 17 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Given the fact that the sample size is the same in both groups, we use the Excel software to randomise. Patients will be randomly divided into two groups of carnitine and pioglitazone and carnitine and metformin.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St.
City
tabriz
Province
East Azarbaijan
Postal code
5165663755
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.TBZMED.REC.1398.270
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver enzymes levels before and after carnitine and pioglitazone administration
Timepoint
At baseline and 3 months later and 6 months after the intervention
Method of measurement
Laboratory methods
2
Description
Ultrasound grade determination before and after carnitine and pioglitazone
Timepoint
At baseline and 6 months after intervention
Method of measurement
Perform liver ultrasound
3
Description
Liver enzymes levels before and after carnitine and metformin
Timepoint
At baseline and 3 months later and 6 months after the intervention
Method of measurement
laboratory methods
4
Description
Ultrasound grade determination before and after carnitine and metformin
Timepoint
At baseline and 6 months after intervention
Method of measurement
Perform liver ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For this group of patients, 1000 mg of carnitine and 30 mg of pioglitazone will be prescribed daily for 6 months. Drugs, especially carnitine, are available at different times at different brands due to the embargo conditions. No specific brand is used and only generic drugs are used. We do not have special equipment. Carnitine with 2 tablets of 500 mg in the morning and evening and pioglitazone with a dose of 30 mg tablets daily is given at noon. Patients are followed every three months and the side effects and intolerance of the drug are checked and in the absence of problems and in case of correct and complete use of the prescribed drug, the second 3-month period is prescribed.
Category
Treatment - Drugs
2
Description
Intervention group: For this group of patients, 1000 mg of carnitine and 500 mg of metformin will be prescribed daily for 6 months. Drugs, especially carnitine, are available at different times at different brands due to the embargo conditions. No specific brand is used and only generic drugs are used. We do not have special equipment. Carnitine with 2 tablets of 500 mg in the morning and evening and metformin with a dose of 500 mg tablets daily is given at noon. Patients are followed every three months and the side effects and intolerance of the drug are checked and in the absence of problems and in case of correct and complete use of the prescribed drug, the second 3-month period is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Manouchehr Khoshbaten
Street address
Aflaknoma Squ, Niayesh Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166618564
Phone
+98 41 3327 3000
Fax
+98 41 3332 8833
Email
tvaliasrhospital@gmail.com
Web page address
http://tabrizhospital.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmodpour
Street address
Golgasht Ave, imam reza hospital clinic
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2084
Email
a.mahmoodpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166618564
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166618564
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available