Protocol summary
-
Study aim
-
Objective: The aim of this study is to determine the effects of omega-3 supplementation on inflammatory factors, oxidative stress biomarkers, pregnancy outcomes, and gene expression related to insulin, lipid, and inflammation in patients with gestational diabetes mellitus.
-
Design
-
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive omega-3 supplement (n=30) or placebo (n=30).
-
Settings and conduct
-
Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients with gestational diabetes mellitus aged 18 to 40 years. Exclusion criteria: Kidney or liver diseases, needing insulin therapy, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers
-
Intervention groups
-
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) for 6 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 6 weeks orally.
-
Main outcome variables
-
Outcomes: Gene expression related to PPAR-γ (primary outcome) and pregnancy outcomes, inflammatory facors, oxidative stress biomarkers and gene expression related to inflammation and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170513033941N42
Registration date:
2018-12-19, 1397/09/28
Registration timing:
retrospective
Last update:
2019-09-21, 1398/06/30
Update count:
1
-
Registration date
-
2018-12-19, 1397/09/28
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-07-03, 1397/04/12
-
Expected recruitment end date
-
2018-08-03, 1397/05/12
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effects of omega-3 supplementation on inflammatory factors, oxidative stress biomarkers, pregnancy outcomes, and gene expression related to insulin, lipid, and inflammation in women with gestational diabetes
-
Public title
-
The effects of omega-3 supplementation in gestational diabetes
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Kidney or liver diseases
Needing insulin therapy
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Kosar clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-07-02, 1397/04/11
-
Ethics committee reference number
-
IR.ARAKMU.REC.1397.114
Health conditions studied
1
-
Description of health condition studied
-
Gestational diabetes mellitus
-
ICD-10 code
-
O24.4
-
ICD-10 code description
-
Gestational diabetes mellitus
Primary outcomes
1
-
Description
-
Expressed levels of PPAR-γ gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
Secondary outcomes
1
-
Description
-
Hs-CRP
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
3
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
4
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
5
-
Description
-
Total antioxidant capacity
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
6
-
Description
-
Expressed levels of LDLR gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
7
-
Description
-
Expressed levels of VEGF gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
8
-
Description
-
Expressed levels of TGF-β gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
9
-
Description
-
Expressed levels of TNF gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
10
-
Description
-
Expressed levels of IL-1 gene
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
11
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Elisa kit
12
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Calculation using HOMA formula
13
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
14
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
15
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
16
-
Description
-
LDL
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
17
-
Description
-
FPG
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
18
-
Description
-
VLDL
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
Intervention groups
1
-
Description
-
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) for 6 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 6 weeks orally.
-
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
-
Arak 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