Protocol summary
-
Study aim
-
Evaluating the effect of omega-3 and zinc oral supplementation on glycemic index, serum zinc levels, body composition and blood pressure in type 2 diabetic patients
-
Design
-
This study will be conducted as a randomized, parallel controlled clinical trial on 80 patients with type 2 diabetes.
-
Settings and conduct
-
This study will be performed as a randomized, parallel controlled clinical trial among patients with type 2 diabetes for 8 weeks.
-
Participants/Inclusion and exclusion criteria
-
Criteria for entering the study: type 2 diabetes and age range older than 18 years
Non-inclusion criteria: insulin infusion. kidney disease. Severe physical activity during the intervention
-
Intervention groups
-
Patients were randomly divided into 3 intervention groups including omega-3 (n = 20), zinc (n = 20), omega-3 and zinc (n = 20) and placebo groups (n = 20) with intervention group (n = 20)
-
Main outcome variables
-
Glycemic indexes, serum zinc level, body composition and blood pressure
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170214032571N9
Registration date:
2018-01-30, 1396/11/10
Registration timing:
retrospective
Last update:
2018-02-19, 1396/11/30
Update count:
1
-
Registration date
-
2018-01-30, 1396/11/10
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
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
-
Evaluating the effect of omega-3 and zinc oral supplementation on glycemic index, serum zinc levels, body composition and blood pressure in type 2 diabetic patients
-
Public title
-
The effect of supplementation of omega-3 and zinc on the treatment of type 2 diabetes
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age range over 18 years old in both sexes
Type 2 diabetes
Exclusion criteria:
Insulin injection
Pregnancy and lactation
Pancreatic cancer
Severe physical activity during the intervention
-
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)
by using simple randomization method. The study groups included omega-3 (A), zinc (B), omega-3 and zinc (C), and placebo-control group (D).
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Assignment to study group was done by a research team member, as the only non-blind person in our study. Other team members (including team leader and study coordinator), as well as all participants remained unaware of the allocations until the end of the study.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-09-10, 1395/06/20
-
Ethics committee reference number
-
Ir.Umsu.Rec.1395.371
Health conditions studied
1
-
Description of health condition studied
-
Type 2 diabetes
-
ICD-10 code
-
E11
-
ICD-10 code description
-
Diabetes mellitus
Primary outcomes
1
-
Description
-
Weight
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Scale, Kg
2
-
Description
-
Body mass index
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Weight(kg) / Height(m)²
3
-
Description
-
Insulin resistance
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
(fasting serum glucose (mmol/L) × fasting serum insulin (μIU/ml))/22.5
4
-
Description
-
Fasting Blood Sugar
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Enzymatic method, mg/dl
5
-
Description
-
Quantitative Insulin Sensitivity Check Index
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
1/ [ log(fasting insulin, µU/ml) + log (fasting glucose, mg/dl) ]
6
-
Description
-
Serum insulin
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Radioimmunoassay
7
-
Description
-
Serum zinc
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Colorimetric
8
-
Description
-
Systolic blood pressure
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Mercury pressure gauge, Mm mercury
9
-
Description
-
Diastolic blood pressure
-
Timepoint
-
At weeks 0, 8
-
Method of measurement
-
Mercury pressure gauge, Mm mercury
Intervention groups
1
-
Description
-
Intervention group: Group A = Intervention with omega-3 at a dose of 1000 mg daily one number capsule for 8 weeks - Dana Pharmaceutical Company
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group: Intervention with zinc at a dose of 30 mg daily One number tablet for 8 weeks - Dine Pharmaceutical Company
-
Category
-
Treatment - Drugs
3
-
Description
-
Intervention group: Intervention with omega-3 at a dose of 1000 mg plus zinc at a dose of 30 mg daily for 8 weeks
-
Category
-
Treatment - Drugs
4
-
Description
-
Receive one daily capsule of placebo containing starch
-
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
-
Oroumia 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)
-
Undecided - It is not yet known if there will be 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
-
Undecided - It is not yet known if there will be 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