Protocol summary

Summary
1) Objectives: Studying the effect of Docosahexaenoic acid on effective factors of vascular thickness and function in diabetic patients. 2) Design: 72 T2DM patients will be evaluated for inclusion criteria and submitters will be divided in 2 age, sex, BMI matched groups (n=36) and will be randomized for intervention. 3) Setting and conduct: blood samples will be collected in starting and end of study and biochemical and anthropometric measurements will be conducted. Weight, height, waist circumference, hip circumference will be measured according to standard methods and obesity and central obesity indices will be calculated. Lipid profile, Fasting Blood Sugar, fasting insulin will be measured according to standard methods and serum LDL cholesterol level and insulin resistance will calculate using equations. We will measure telomerase activity by using PCR- ELISA, ADMA and sCD163 by ELISA kits and expression of interleukin 6 and TNF-alpha genes with real-time PCR. Questionnaires will be filled up and 3 day food record forms will be delivered to patients to fill them in first and last week of intervention. 4) Participants: 72 T2DM patients (males and females); Age from 30 to 70 years old and Body Mass Index from 18.5 to 30 kg/m2 Main exclusion criteria: Insulin therapy; any type of Cancer; Liver, Kidney, Coagulation, Thyroid, Cardiovascular disorders; consumption of Anticoagulants, ant-inflammatory drugs; Fibrates; Thiazolidinedione’s; Supplementation with omega-3, vitamin A,D and B6 5) Intervention: Participants will receive 2 gram per day DHA or placebo (Sunflower oil) capsules, for 8 weeks. 6) Main outcome variables: Interleukin 6 gene expression, TNF-α gene expression, ADMA, sCD163, Telomerase activity, Total cholesterol, Triglyceride, HDL- cholesterol, LDL-cholesterol, Fasting Blood Sugar, Fasting insulin, Insulin resistance, Glycated hemoglobin

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071213964N1
Registration date: 2013-09-15, 1392/06/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-15, 1392/06/24
Registrant information
Name
Omid Toupchian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 4806
Email address
o-toupchian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1) Tehran University of Medical Sciences2) Endocrinology and Metabolism Research Institute of Tehran University
Expected recruitment start date
2013-09-06, 1392/06/15
Expected recruitment end date
2014-02-04, 1392/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DHA supplementation on factors influencing vascular thickness and intima-media smooth muscle proliferation in patients with type 2 diabetes mellitus
Public title
The effect of Docosahexaenoic acid on factors influencing vascular thickness and function in diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic patients (both males and females); 30-70 years old age; BMI range between 18.5 to 35 kg/m2 Exclusion criteria: Insulin therapy; any type of Cancer; Liver, Kidney, Coagulation and Thyroid disorders; Cardiovascular diseases such as Angina Pectoris, Myocardial infarction, Stroke; consumption of Anticoagulants, ant-inflammatory and lipid lowering agents such as Fibrates; Thiazolidinedione’s therapy; History of Allergic reaction to fish or fish oil; Daily consumption of fish or fish oil supplements; Supplementation with vitamin A,D and B6; Pregnancy and Lactating; lack of usage more than 10% of administered tablets.
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
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
Ethics Committee of Tehran University of Medical Sciences
Street address
School of Nutrition and diet therapy, Tehran University of Medical Sciences, 16 Azar Ave, Enghelab Sq., Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
2229187101

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes melitus
ICD-10 code
E11
ICD-10 code description
non-insulin-dependent diabetes

2

Description of health condition studied
Atherosclerosis
ICD-10 code
I70
ICD-10 code description
Arterial sclerosis

Primary outcomes

1

Description
Interleukin 6 gene expression
Timepoint
start and end of intervention
Method of measurement
Real time PCR

2

Description
TNF-α gene expression
Timepoint
start and end of intervention
Method of measurement
Real time PCR

3

Description
ADMA
Timepoint
start and end of intervention
Method of measurement
ELISA

4

Description
sCD163
Timepoint
start and end of intervention
Method of measurement
ELISA

5

Description
Telomerase activity
Timepoint
start and end of intervention
Method of measurement
PCR-ELISA kit

6

Description
Total cholesterol
Timepoint
start and end of intervention
Method of measurement
Turbidimeter

7

Description
Triglyceride
Timepoint
start and end of intervention
Method of measurement
Turbidimeter

8

Description
HDL- cholesterol
Timepoint
start and end of intervention
Method of measurement
Turbidimeter

9

Description
LDL-cholesterol
Timepoint
start and end of intervention
Method of measurement
Friedewald formula

10

Description
Fasting Blood Sugar
Timepoint
start and end of intervention
Method of measurement
Turbidimeter

11

Description
Fasting insulin
Timepoint
start and end of intervention
Method of measurement
ELISA

12

Description
Insulin resistance
Timepoint
start and end of intervention
Method of measurement
Formula

13

Description
Glycated hemoglobin
Timepoint
start and end of intervention
Method of measurement
Kit

Secondary outcomes

1

Description
Vascular function and proliferation of smooth muscle cells in intima media
Timepoint
start and end of intervention
Method of measurement
Studding the effective factors in vascular function and proliferation of smooth muscle cells in intima media and also comparison of these factors in two intervention and control groups

Intervention groups

1

Description
Intervention group: DHA supplement (2 gr per day , 3 month)
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule (containing Sunflower oil similar to DHA capsule) with similar dose (2 gr per day) and similar period (3 month)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Endocrinology and Metabolism Research Institute of Tehran University
Full name of responsible person
Dr Ensieh Nasli
Street address
Endocrinology and Metabolism Research Institute, Shariati Hospital, North Karegar Avenue, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
School of Nutrition and Diet therapy, Tehran University of Medical Sciences, 16 Azar Ave, Enghelab Sq, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr. Ensieh Nasli
Street address
Endocrinology and Metabolism Research Institute, Shariati Hospital, North Karegar Avenue, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Omid Toupchian
Position
PhD candidate in nutrition and diet therapy
Other areas of specialty/work
Street address
School of Nutrition & Diet therapy, Before Intersection of Shahid Chamran Highway, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8862 2706
Fax
Email
o-toupchian@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fariba Koohdani
Position
PhD in nutrition (َAssociate Professor)
Other areas of specialty/work
Street address
School of Nutrition & Diet therapy, Before Intersection of Shahid Chamran Highway, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8862 2706
Fax
Email
fkoohdan@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Toupchan
Position
PhD candidate in Nutrition and Diet Therapy
Other areas of specialty/work
Street address
School of Nutrition & Diet therapy, Before Intersection of Shahid Chamran Highway, Shahid Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
Fax
Email
o-toupchian@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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