Determining the effect of omega-3 supplementation on endothelial function, vascular structure and metabolic parameters in children and adolescents with type 1 diabetes
Design
The present study is a double-blind randomized, placebo-controlled randomized clinical trial in which one group received omega-3 supplements and one group received placebo. The statistical population of this study is all adolescents (10 to 18 years old), who have been diagnosed with type 1 diabetes by a specialist.
Settings and conduct
Participants are selected from Mofid Children's Hospital according to the inclusion and exclusion criteria of a study
Participants/Inclusion and exclusion criteria
Inclusion criteria
Adolescents 10 to 18 years
Body mass index of people between 5 to 85 percent
Type 1 diabetes according to the doctor's diagnosis and receiving insulin routine
At least 5 years have passed since the diagnosis of type 1 diabetes
Willingness to cooperate
Exclusion criteria
Consumption of antihypertensive and lipid lowering drugs, anticoagulants or anti-inflammatory drugs and weight loss substances and drugs, history of using anti-inflammatory and antioxidant supplements and omega 3 in the last 6 months, endocrine and metabolic diseases history of fish and seafood allergies
Acute disease that needs treatment
smoking
Systolic or diastolic blood pressure above 90 percent
Pregnancy and lactation
Diabetic ketoacidosis in the last 12 months or hypoglycemia (blood sugar less than 50 mg / dl) in the last 3 months
Intervention groups
Patients take a daily 600 mg supplement containing 120 mg DHA and 180 mg EPA or placebo for 12 weeks. Its omega 3 placebo is designed by Karen Pharmaceutical Company (Yazd, Iran) in appearance and color similar to omega 3 capsules (containing 600 mg of oral glycerin).
The effect of omega-3 supplementation on endothelial function, vascular structure and metabolic parameters in adolescents with type 1 diabetes
Public title
The effect of omega-3 supplementation on endothelial function, vascular structure and metabolic parameters in adolescents with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents 10 to 18 years
Body mass index of people between 5 and 85 percent
Having type 1 diabetes as determined by doctor and receiving insulin routine
At least 5 years have passed since the diagnosis of type 1 diabetes
Willingness to cooperate
Exclusion criteria:
Age
From 10 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the size 4 random blocks method is used, produced by Excel software and the process of placing patients in groups is determined based on these blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a two-way blind study in which participants, researchers, observers and analysts are not aware of the contents of the cans. In order to hide, a unique code is inserted by the manufacturer on the cans containing omega 3 and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.IUMS.REC.1400.070
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
flow mediated dilation
Timepoint
At the beginning of the study and 12 weeks after starting the omega-3 supplementation
Method of measurement
Doppler ultrasound device
Secondary outcomes
1
Description
Carotid intima-media thickness
Timepoint
At the beginning of the study and 12 weeks after starting the omega-3 supplement
Method of measurement
Doppler ultrasound device
2
Description
Fasting plasma glucose
Timepoint
Before and after intervention
Method of measurement
Enzyme essay
3
Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Photometric
4
Description
High density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Photometric
5
Description
Low density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Calculation
6
Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Photometric
7
Description
Insulin
Timepoint
Before and after intervention
Method of measurement
ELISA
8
Description
Hemoglobin A1C
Timepoint
Before and after intervention
Method of measurement
Enzymatic method
9
Description
BMI for age Z-score
Timepoint
Before and after intervention
Method of measurement
Calculation
10
Description
Weight
Timepoint
Before and after intervention
Method of measurement
Scale
11
Description
Physical activity
Timepoint
Before and after intervention
Method of measurement
Questionnaire
12
Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
ELISA
13
Description
ESR
Timepoint
Before and after intervention
Method of measurement
Measurement of erythrocyte sedimentation rate with a special tube
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Nahid Aryaeian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
nah_arya2002@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nahid Aryaeian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
nah_arya2002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoud khorshidi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
khorshidi.2065@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Title and more details about the data/document
All unidentifiable data can be shared
When the data will become available and for how long
The start of the data access period is 6 months after the results are published
To whom data/document is available
All researchers, policymakers and people in the industry
Under which criteria data/document could be used
There will be no other condition
From where data/document is obtainable
Name: Masoud Khorshidi
Email: khorshidi.2065@gmail.com
telephone: 00982186709
Address: Faculty of Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran.
What processes are involved for a request to access data/document
Send the request via email to the respondent, check the email within 2 weeks and reply to the email