Determining the effect of omega-3 on blood sugar control in type 2 diabetic patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized on the number of 188 patients with type 2 diabetes in Farhikhtegan Hospital using simple randomization.
Settings and conduct
In this trial, after obtaining the code of ethics, 188 patients with type 2 diabetes of Farhikhtegan Hospital were enrolled in the study after filling out the questionnaire. For double-blindness of the drugs used by the supervisor, they were divided into A/B groups. 3 capsules of 1000 mg of omega-3 were given for 12 weeks, and the control group took 3 placebo pills daily for 12 weeks.
Participants/Inclusion and exclusion criteria
Age 30 to 40 years, declaration of satisfaction by the patient, suffering from type 2 diabetes, under the care of Farhikhtegan Hospital, body mass index less than 30
Intervention groups
The treatment group was given 3000 mg of omega-3 fatty acid to investigate the effect of omega-3 on the blood sugar of type 2 diabetic patients, and the control group was given a placebo for 12 weeks to compare with the results of the intervention group.
Main outcome variables
The meaningless effect of omega-3 on fasting blood sugar; The meaningless effect of omega-3 on hemoglobin A1c; Significant effect of omega-3 on triglycerides.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210928052621N1
Registration date:2023-09-04, 1402/06/13
Registration timing:prospective
Last update:2023-09-04, 1402/06/13
Update count:0
Registration date
2023-09-04, 1402/06/13
Registrant information
Name
Alireza Panahian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3368 4906
Email address
ar_panahian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acids on Glycemic control in type 2 diabetic patients
Public title
The effect of omega-3 on Diabet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from type 2 diabetes
Consent to participate in the intervention
Age between 40 and 70 years
Under the care of Farhikhtegan Hospital
bmi less than 30
Exclusion criteria:
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the double-blindness of this study, the drugs used for the patients were divided by the head of the department in A/B form at the beginning of the study so that the researcher and the participants did not know the type of drug received. For randomization, each patient was first given a number from 1 to 188, then using online random numbers from 1 to 188, 94 numbers were randomly generated. Patients with these numbers were in the treatment group and patients with The remaining numbers were placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor is unaware of the study groups, the patient is unaware of the study groups, the researcher is unaware of the study groups, the data analyst is unaware of the study groups .The division of patients into drug and placebo groups is done by a nurse outside of the above groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Azad University of Medical Sciences
Street address
Headquarters Building of Islamic Azad University of Medical Sciences , Corner of Gol Yakh St , Ayene Blvd , Amir Pabarja St , Doctor Shariati St.
City
tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-10-17, 1401/07/25
Ethics committee reference number
IR.IAU.TMU.REC.1401.323
Health conditions studied
1
Description of health condition studied
diabet type 2
ICD-10 code
Z71.3
ICD-10 code description
Dietary counseling and surveillance
Primary outcomes
1
Description
FBS
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after receiving the Omega 3 drug
Method of measurement
Blood Test
2
Description
HbA1C
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after receiving the Omega 3 drug
Method of measurement
Blood Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 3000 mg of omega-3 fatty acid (3 capsules of 1000 mg in the morning, noon, and night from Dana Pharmaceutical Company under the brand name Omega Rex) was given for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: The placebo control group (containing 300 mg of polyunsaturated fatty acid, 100 mg of unsaturated fatty acid and 600 mg of linoleic acid) was given 3 times a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
farhikhtegan hospital
Full name of responsible person
Alireza Panahian
Street address
Farhikhtegan Hospita , Daneshgah Square , At the end of Sattari Highway
City
tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
farhikhteganhospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
معاون تحقیقات و فناوری
Street address
Tehran Azad University of Medical Sciences , Danesh Dead End, Atardi Moghadam St., Khagani St., Doctor Shariati St.
City
tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2200 6660
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Alireza Panahian
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
in front of the Central Organization of Islamic Azad University, University Square, At the end of Sattari North
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
ar_panahian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Panahian
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Farhikhtegan hospital, In front of the Central Organization of Azad University , hesarak , End of Satari Boulevard
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
ar_panahian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza panahian
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
in front of the Central Organization of Islamic Azad University, University Square, At the end of Sattari North
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
ar_panahian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The intervention was conducted on a small number of samples, and to draw conclusions, a large sample size and more facilities are needed, which were not possible in this trial.