The aim of this study is investigate the effect of l-carnitin administration in the type2 diabetic patient with non alcoholic fatty liver disease and comparision with the plasebo.This study will be randomized and double blind trial. Inclusion criteria:Known case of diabetic type2؛ serum level of alanin aminotranspherase and aspartat aminotranspherase more than 2time of normal؛ high serum level of triglicirid and cholestrol level؛ ultrasonograghy evidences of fatty live.
Exclusion criteria: any causes of increasing liver enzymes such as viral infections؛ hemochromatosis ؛alfa 1 anti tripsin dificience؛ Wilson’s disease؛ autoimmune diseases؛drinking (20 and 10 grams per day for men and women, respectively). 30 Patient will selected among patients referring to Gastroentrology cliic of Jundishapur University of Medical Sciences and will divided equaly in two intervention or control group. The patients in the intervention group will be received 750 mg l-carnitin every 8 hours for 3 months and in control group will received placebo every 8 hours forthree months. Main outcome measures are changes in aminotransferase serum level and triglicirid and cholestrol level and the grade of fatty liver determined by ultrasonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020316348N2
Registration date:2014-03-10, 1392/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-10, 1392/12/19
Registrant information
Name
Mahmod Chobineh
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1375 7274
Email address
chobineh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gastroentrology center of Jundishapur University of Medical Sciences
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
L-carnitine effect in the treatment of non alcoholic fatty liver disease in typ 2 diabetic patients and comparision with placebo
Public title
L-carnitine effect in diabetic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Known case of diabetic type2 ؛ serum level of alanin aminotranspherase and aspartat aminotranspherase more than 2time of normal؛ and high level of triglicirid and cholestrol level ؛ ultrasonograghy evidences of fatty live.
Exclusion criteria: any causes of increasing liver enzymes such as viral infections؛ hemochromatosis ؛alfa 1 anti tripsin dificiency؛Wilson’s disease؛ autoimmune diseases؛ drinking (20 and 10 grams per day for men and women, respectively)
Age
From 14 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine, Ahwaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Street -
City
ahwaz
Postal code
61355393
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
ajums.rec.1392.199
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver disease
ICD-10 code
K76.1
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
Liver aminotransferase
Timepoint
Before intervention and three months after initiation of the intervention
Method of measurement
Eliza
Secondary outcomes
1
Description
Serum level of triglicirid and cholestril
Timepoint
Before intervention and three months after initiation of the intervention
Method of measurement
Eliza
2
Description
Fasting blood glucos test
Timepoint
Before intervention and three months after initiation of the intervention
Method of measurement
Eliza
Intervention groups
1
Description
IN intervention group: 750 mg L- carnitine, three times a day for three months
Category
Treatment - Drugs
2
Description
IN control group: plasebo three times a day for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroentrology Clinic, Ahwaz Jundishapur Medical School
Full name of responsible person
Chobineh Mahmod
Street address
Imam Khomini hospital, Azadegan Blvd
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gastroentrology Recerch Center, Ahwaz Jundishapur Medical School
Full name of responsible person
Alavinehzad Pejman,Dr
Street address
Gastroentrology Recerch Center, Ahwaz Jundishapur Medical School
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gastroentrology Recerch Center, Ahwaz Jundishapur Medical School
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Chobineh Mahmod
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Department of Internal medicine, Golestan Hospital, Golestan street, Ahwaz
City
Ahwaz
Postal code
61355393
Phone
+98 61 1375 7274
Fax
+98 61 1336 9539
Email
chobineh.m@ajums.ac.ir chobinehmahmod@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine, Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Alavinezhad Peiman,Dr
Position
Subspeciality In Gasrology
Other areas of specialty/work
Street address
Department of Internal medicine, Golestan Hospital, Golestan street, Ahwaz
City
Ahwaz
Postal code
61355393
Phone
+98 61 1374 3001
Fax
+98 61 1336 9539
Email
palavinezhad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapoor Medical Scince Univercity
Full name of responsible person
Chobineh Mahmod
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Jundishapur University of Medical Sciences, Golestan St
City
Ahwaz
Postal code
61355393
Phone
+98 61 1375 7274
Fax
Email
chobineh.m@ajums.ac.ir chobinehmahmod@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)