60 Type 2 diabetic willing to participate in the study consideration of inclusion and exclusion criteria will be invited in this study. The Pro12Ala polymorphism of the PPARγ2 gene will be detected by the RFLP method. Homozygote individual for Pro allele ( PPARγ2 Pro12Pro) and recessive allele (Pro12Ala or Ala12Ala) will be identified. Then matching will be done for BMI, age and sex between control and intervention groups. The following groups will be studied(15 patients in each group):
- Ala12Ala or Pro12Ala genotype who will received DHA supplement
- Ala12Ala or Pro12Ala genotype who will received placebo
- Pro12Pro genotype who will received DHA supplement
- Pro12Pro genotype who will received placebo
each patient will intake 2 gram DHA (Decosahexanoic Acid) or sunflower oil as placebo for 12 weeks. In the start of study patient learn about food record and three-day food record will be done in the first and end week of intervention by patients. physical activity will be assessed by valued physical activity questionnaire.
Experiments: Before and after of intervention anthropometric measures, lipid profile, fasting blood sugar, Insulin, gene expression of LXR and ABCA1 and adiponectine concentration will be measured.
Analysis: food intake and biochemistry and gene expression information will be analysis by statistical software at the end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071914013N1
Registration date:2013-08-23, 1392/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Anahita Mansoori
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 1514
Email address
a-mansoori@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Endocrinology and Metabolism Research Institute of Tehran University
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DHA supplement on PPARγ- LXRα- ABCA1 pathway in PPARγ2 Pro12Ala genetic variants in type 2 diabetes
Public title
The effect of DHA supplement on lipid metabolism in diabetic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic willing to participate in the study;BMI (kg/m2) between 18.5 to 35; Age from 30 to 60 year
Exclusion criteria: Insulin therapy; Thiazolidinediones therapy; Liver, kidney, coagulation and thyroid disorders; Anticoagulation, ant-inflammation and lipid lowering drug consumption; History of Allergic reaction to fish or fish oil; Daily consumption of fish or w3 supplement; Supplementation with vitamin A,D and B6
Age
From 30 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)
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
Tehran University of Medical Sciences
Street address
Nutrition and dietetics school, Tehran University of Medical Sciences, 16 Azar Ave, Enghelab Sq, Tehran
City
Tehran
Postal code
Approval date
2013-07-17, 1392/04/26
Ethics committee reference number
92-01-16-20454-89521
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
TG
Timepoint
before and after of intervention
Method of measurement
Enzymatic kit
2
Description
HDL.c
Timepoint
before and after of intervention
Method of measurement
Enymatic kit
3
Description
LDL.c
Timepoint
before and after of itervention
Method of measurement
Enzymatic Kit
4
Description
Chol
Timepoint
before and after of intervention
Method of measurement
Enzymatic kit
5
Description
ABCA1 gene expression
Timepoint
before and after of intervention
Method of measurement
Real time PCR
6
Description
LXRa gene expression
Timepoint
before and after of intervention
Method of measurement
Real time PCR
Secondary outcomes
1
Description
waist circumference
Timepoint
before and after of interention
Method of measurement
tape meter
2
Description
weight
Timepoint
before and after of intervention
Method of measurement
digital scale
3
Description
BMI
Timepoint
before and after of intervention
Method of measurement
It is calculated by dividing weight(Kg) by height squar(m)
4
Description
body fat percent
Timepoint
before and after of intervention
Method of measurement
BIA
5
Description
fasting blood sugar
Timepoint
before and after of sintervention
Method of measurement
Enzymatic Kit
6
Description
Insulin
Timepoint
before and after of study
Method of measurement
Radioimmunoassy kit(RIA)
7
Description
Adiponectine
Timepoint
before and after of intervention
Method of measurement
ELISA kit
Intervention groups
1
Description
Ala12Ala or Pro12Ala genotype who will received DHA supplement: DHA supplement in shape of soft gel, 2 gram per day for 12 weeks, twice a day with main meal
Category
Treatment - Other
2
Description
Ala12Ala or Pro12Ala genotype who will received placebo : sunflower oil as placebo in shape of soft gel, 2 gram per day for 12 weeks, twice a day with main meal
Category
Placebo
3
Description
Pro12Pro genotype who will received DHA supplement: DHA supplement in shape of soft gel, 2 gram per day for 12 weeks, twice a day with main meal
Category
Treatment - Other
4
Description
Pro12Pro genotype who will received placebo: sunflower oil as placebo in shape of soft gel, 2 gram per day for 12 weeks, twice a day with main meal