Studying the effect of weight loss through calorie restricted diet on apoptotic factor levels of cytokeratin 18 and indicators of liver dysfunction in patients with non-alcoholic steatohepatitis (NASH)
The aim of this study is to evaluate the effect of weight loss on the levels of the cytokeratin 18 apoptotic marker, liver dysfunction factors, and fibrosis and hepatic steatosis detected by fibroscopy. The population of the study is consisted of 60 people who were selected from non-alcoholic liver patients referring to Apadana Clinic based on entry and exit criteria or simple random method. Entrance criteria: BMI 25-40, liver fibrosis 2 and higher, liver enzymes 1.5 fold. Exit criteria: Viral hepatitis, the use of toxic liver drugs, taking alcohol and other liver diseases. This intervention has no control group as well as placebo.
The intervention involves receiving a calorie-restricted diet of 500 kcal (individuals with a BMI of 25-30) and 1000 kcal (individuals with a BMI of 35-40) that should be followed for 6 consecutive months. Biochemical tests, as well as 24-hour recall, record anthropometric measurements for all patients are done at beginning of intervention and 3 and 6 months after the intervention. Six months after the intervention, cytokeratin 18 levels are measured by the ELISA kit in frozen serum samples. Patients will be referred to Apadana Clinic to perform fibroscopy to assess the effect of diet and weight loss on liver steatosis and fibrosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081535707N1
Registration date:2017-10-15, 1396/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Sepideh Mohammadpour
Name of organization / entity
Nutrition group. Medicine faculty. Mashhad university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38828888051
Email address
mohammadps941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of Medical Science
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of weight loss through calorie restricted diet on apoptotic factor levels of cytokeratin 18 and indicators of liver dysfunction in patients with non-alcoholic steatohepatitis (NASH)
Public title
Effect of weight loss on improvement of liver inflammation and fibrosis in non- alcoholic fatty liver patients through calorie restricted diet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. BMI 25-40؛ Hepatic fibrosis 2 and higher؛ Liver enzymes 1.5 times more natural
Exclusion criteria: Viral hepatitis B, c ؛ Liver Cancer؛ alcohol consumption؛ Pregnancy ؛ Hepatic autoimmune diseases؛ Taking hepatotoxic drugs؛ Taking vitamin D supplement pills ؛ Patient's denial؛ Failure to observe the diet
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Nutrition group. Medicine faculty. Mashhad university of medical sciences. vakilabad blvd. azadi sqr. Mashhad
City
Mashhad
Postal code
9177948564
Approval date
2017-08-09, 1396/05/18
Ethics committee reference number
IR.MUMS.fm.REC.1395.498
Health conditions studied
1
Description of health condition studied
Non-Alcoholic Fatty Liver - Non -Alcoholic Steatohepatitis
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
Cytokeratin 18
Timepoint
First, 3 and 6 months after intervention
Method of measurement
ELIZA Kit
2
Description
Liver dysfunction factors
Timepoint
First.3 and 6 months after intervention
Method of measurement
Biochemistry Lab
Secondary outcomes
1
Description
Liver Fibrosis
Timepoint
First,6 months after intervention
Method of measurement
Fibroscan Of liver
2
Description
Anthropometric measurements
Timepoint
first, 3 and 6 months after the intervention
Method of measurement
BIA device. Measuring body size with meter
Intervention groups
1
Description
This study includes a group of 60 patients with non-alcoholic fatty liver disease. Intervention is performed for all of these patients and the study does not have the control group. The intervention includes a restricted calorie diet of 500 kcal for people with a BMI of 25-30 and a 1000 kcal for people with a BMI of 30-40.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fiber scan center , Apadana Diagnostic Clinic.
Full name of responsible person
Dr.azita ganji
Street address
Apadana building ,East Golestan St. , Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Safarian
Street address
Nutrition group. Medicine faculty. Mashhad university of Medical Sciences. vakilabad blvd. azadi sqr. Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohammad Safarian
Position
Nutritionist ,Associate Professor of nutrition group ,Mashhad University of Medical Sciences
Other areas of specialty/work
Street address
Nutrition group. Medicine faculty. Mashhad university of Medical Sciences. vakilabad blvd. azadi sqr. Mashhad