Protocol summary
-
Study aim
-
The aim of this study is evaluate the effect of omega-3 and zinc supplements on inflammatory status, lipid profiles and antioxidant capacity in type 2 diabetic patients.
-
Design
-
In this study, 80 patients with type 2 diabetes who were admitted to study at the endocrine clinic of Imam Khomeini Hospital in Urmia were selected. The participants are randomly divided into four intervention and control groups and each participant is assigned a code.
-
Settings and conduct
-
This study will be conducted at Urmia University of Medical Sciences for 8 weeks. In this study, 1000 mg of omega-3 (180 mg of eicosapentaenoic acid and 120 mg of deca-hexaenoic acid) and 30 mg of zinc per day will be given.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria include people with type 2 diabetes without insulin injections. Insulin infusion and kidney problems are among the criteria for withdrawal.
-
Intervention groups
-
Patients were randomly will be divided into 3 intervention groups including interventional group with omega-3 (n = 20), interventional group with Zn (n = 20), interventional group omega-3 with zinc (n = 20) and placebo group (n = 20).
-
Main outcome variables
-
Lipid profile (total cholesterol; HDL; LDL; triglyceride); inflammatory status (Hs-CRP); total antioxidant capacity (TAC) in this study once at the beginning of the study and once at the end of the study will be evaluated.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170214032571N2
Registration date:
2018-01-13, 1396/10/23
Registration timing:
retrospective
Last update:
2018-03-11, 1396/12/20
Update count:
1
-
Registration date
-
2018-01-13, 1396/10/23
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Support by Urmia University of Medical Sciences
-
Expected recruitment start date
-
2016-09-30, 1395/07/09
-
Expected recruitment end date
-
2016-11-20, 1395/08/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of supplemental omega-3 and zinc supplementation on inflammation, lipid profiles and antioxidant capacity in type 2 diabetic patients
-
Public title
-
The effect of omega-3 and zinc in the treatment of diabetes
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
tendency to Cooperation
Type 2 diabetic patients ; taking metformin or glibenclamide glucose or similar drugs by patients
Age range 18 to 65 years
use of lipid lowering statin drugs and a blood pressure lowering drugs
Exclusion criteria:
Unwillingness to participate in the study
Insulin injection
Do not consume 80% of supplements per course
People with pancreatic cancer and patients receiving steroidal anti-inflammatory drugs (due to secondary hyperglycemia)
severe physical activity
Use of omega-3 and zinc supplementation in the last three months
developing any underlying coronary artery disease and cancer
taking antidepressants (because of interactions with zinc supplementation)
-
Age
-
From 18 years old to 65 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
-
Sample size
-
Target sample size:
80
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients were divided into 4 equal groups of 20 (A total of 80),A , B, C and D,
by using simple randomization method.The study groups included omega-3 (A), zinc (B), omega-3 and zinc (C), and placebo-control group (D).Randomization was assigned to a random assignment list by a research team member.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization was assigned to a random assignment list by a research team member as the only non-blind person. Other members of the research team (including team leader and study coordinator) as well as all participants participated in the random allocation of blind groups and remained blind until the end of the study.In fact, in this study, patients were blinded to use of placebo or supplementation. Also, all of the study subjects were blind except for one group.
-
Placebo
-
Used
-
Assignment
-
Factorial
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-09-09, 1395/06/19
-
Ethics committee reference number
-
IR.UMSU.REC.1395.370
Health conditions studied
1
-
Description of health condition studied
-
Type 2 diabetes
-
ICD-10 code
-
E10, E11,
-
ICD-10 code description
-
Diabetes mellitus
Primary outcomes
1
-
Description
-
Total cholesterol
-
Timepoint
-
Before intervention and two months after intervention
-
Method of measurement
-
Enzymatic method, mg / dl
2
-
Description
-
TAC
-
Timepoint
-
Before intervention and two months after intervention
-
Method of measurement
-
Colorimetric
3
-
Description
-
hs-crp
-
Timepoint
-
Before intervention and two months after intervention
-
Method of measurement
-
Eliza-mg/dl
4
-
Description
-
HDL
-
Timepoint
-
Before intervention and two months after intervention
-
Method of measurement
-
Enzymatic method, mg / dl
5
-
Description
-
Tri glyceride
-
Timepoint
-
Before intervention and two months after intervention
-
Method of measurement
-
Enzymatic method, mg / dl
6
-
Description
-
LDL
-
Timepoint
-
Before intervention and two months after intervention
-
Method of measurement
-
Enzymatic method, mg / dl
Intervention groups
1
-
Description
-
Group A = Intervention group with omega-3 doses of 1000 mg with lunch
-
Category
-
Treatment - Drugs
2
-
Description
-
Group C = Omega 3 group with zinc
-
Category
-
Treatment - Drugs
3
-
Description
-
Group A = Intervention group with zinc dose of 30 mg in the evening meal
-
Category
-
Treatment - Drugs
4
-
Description
-
Group D = Receptor of Starch Placebo
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
-
Grant code / Reference number
-
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Urmia 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
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
-
Unwillingness to publish individual data
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available
-
Title and more details about the data/document
-
In this study, only the original outcome can be published
-
When the data will become available and for how long
-
Start the access period one year after the print results
-
To whom data/document is available
-
People working in academic institutions
-
Under which criteria data/document could be used
-
is not allowed type of analysis on data
-
From where data/document is obtainable
-
Phone number 09132801511 and email mehdikhakian1371@yahoo.com
-
What processes are involved for a request to access data/document
-
Applicants will be able to access data after two months of requesting data, with full details of their profile.
-
Comments
-