Protocol summary
-
Study aim
-
Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with gestational diabetes.
-
Design
-
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
-
Settings and conduct
-
Population and sample size: 40 patients with gestational diabetes of eligible and referred to Kosar gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria:Taking fish oil supplements, insulin therapy, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
-
Intervention groups
-
Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
-
Main outcome variables
-
Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201610015623N90
Registration date:
2016-10-11, 1395/07/20
Registration timing:
retrospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
-
Registration date
-
2016-10-11, 1395/07/20
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Arak University of Medical Sciences
-
Expected recruitment start date
-
2016-07-26, 1395/05/05
-
Expected recruitment end date
-
2016-08-10, 1395/05/20
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of fish oil supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with gestational diabetes
-
Public title
-
Effect of supplementation in treatment of women with gestational diabetes
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with gestational diabetes
Aged 18 to 40 years
Exclusion criteria:
Taking fish oil supplements
Insulin therapy
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
40
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization will be done by the use of computer-generated random numbers.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-07-25, 1395/05/04
-
Ethics committee reference number
-
IR.ARAKMU.REC.1395.160
Health conditions studied
1
-
Description of health condition studied
-
Gestational diabetes
-
ICD-10 code
-
O24.9
-
ICD-10 code description
-
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
-
Description
-
PPAR-γ
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
Secondary outcomes
1
-
Description
-
Gene expression of interleukin 1
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
2
-
Description
-
Gene expression of tumor necrosis factor alpha
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
3
-
Description
-
Gene expression of interleukin 8
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
4
-
Description
-
Gene expression of LDLR
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
PCR
5
-
Description
-
Fasting plasma glucose
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
ELISA kit
7
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Calculation using HOMA formula
8
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
9
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
10
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Enzymatic kit
11
-
Description
-
High-sensitivity C-reactive protein
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
ELISA kit
12
-
Description
-
Newborn's head circumference
-
Timepoint
-
Delivery time
-
Method of measurement
-
Tape
13
-
Description
-
Polyhydramnios
-
Timepoint
-
End-of-trial
-
Method of measurement
-
Sonographic
14
-
Description
-
Apgar score
-
Timepoint
-
Delivery time
-
Method of measurement
-
Clinical observation
15
-
Description
-
Preterm delivery
-
Timepoint
-
After delivery
-
Method of measurement
-
Medical record
16
-
Description
-
Maternal pre-eclampsia
-
Timepoint
-
After delivery
-
Method of measurement
-
Medical record
17
-
Description
-
Newborn's length
-
Timepoint
-
Delivery time
-
Method of measurement
-
Delivery time
18
-
Description
-
Newborn's weight
-
Timepoint
-
Delivery time
-
Method of measurement
-
Scale
Intervention groups
1
-
Description
-
Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Vice chancellor for research, 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