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
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: Taking any supplements before the intervention, Needing insulin therapy, Placenta abruption, 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:2018-12-19, 1397/09/28
Update count:1
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-03, 1397/04/12
Expected recruitment end date
2018-07-22, 1397/04/31
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: Taking any supplements before the intervention
Needing insulin therapy
Placenta abruption
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
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 LDL-R 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