Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of selenium supplementation on insulin resistance, inflammatory factor and biomarkers of oxidative stress in gestational diabetes.
-
Design
-
Double-blind randomized controlled clinical trial.
-
Settings and conduct
-
Seventy patients with gestational diabetes mellitus among pregnant women of eligible and referred to maternity clinics affiliated with the Arak University of Medical Sciences, Arak, Iran in the study will be selected.
-
Participants/Inclusion and exclusion criteria
-
Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Women with intrauterine fetal death (IUFD), premature preterm rupture of membrane (PPROM), placenta abruption, preeclampsia, eclampsia, chronic hypertension, hypo- or hyperthyroidism, urinary tract infection, smokers, and those with kidney or liver diseases or those taking estrogen therapy, women who required commencing insulin therapy and stressful life conditions will be excluded from the present study.
-
Intervention groups
-
Patients will be assigned to receive either selenium supplement (intervention group) or placebo (control group).
-
Main outcome variables
-
Fasting plasma glucose (FPG), insulin resistance, serum insulin, hs-CRP levels, nitric oxide, lipid profiles, biomarkers of oxidative stress and blood pressure
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201403175623N18
Registration date:
2014-03-25, 1393/01/05
Registration timing:
registered_while_recruiting
Last update:
2019-09-22, 1398/06/31
Update count:
1
-
Registration date
-
2014-03-25, 1393/01/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Arak University of Medical Sciences
-
Expected recruitment start date
-
2014-03-18, 1392/12/27
-
Expected recruitment end date
-
2014-05-16, 1393/02/26
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effect of selenium supplementation on insulin resistance, oxidative stress and inflammatory factors in women with gestational diabetes
-
Public title
-
Effect of selenium in treatment of gestational diabetes
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Pregnant women aged 18-40 years
Pregnant women diagnosed with gestational diabetes mellitus
24-28 weeks' gestation
Exclusion criteria:
Intrauterine fetal death
Premature preterm rupture of membrane
Placenta abruption
Preeclampsia
Eclampsia
Chronic hypertension
Hypo- or hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
Those taking estrogen therapy
Stressful life conditions
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
2
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
70
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
At study baseline and after balanced block randomization, subjects will be randomly divided into two groups to take either selenium supplementation (n = 35) or placebo (n = 35). Randomization will be done by the use of computer-generated random numbers.
-
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 maternity clinics affiliated with the Arak University of Medical Sciences, Arak, Iran, 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
-
2014-03-17, 1392/12/26
-
Ethics committee reference number
-
12-160-92
Health conditions studied
1
-
Description of health condition studied
-
Gestational diabetes mellitus
-
ICD-10 code
-
O24.9
-
ICD-10 code description
-
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
-
Description
-
Insulin resistance
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Calculation using HOMA formula
Secondary outcomes
1
-
Description
-
Insulin
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Elisa kit
2
-
Description
-
Total cholesterol
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Enzymatic kit
3
-
Description
-
Triglycerides
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
HDL
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
LDL
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
High-sensitivity C-reactive protein
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Elisa kit
7
-
Description
-
Nitric oxide
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Spectrophotometry
8
-
Description
-
Malondialdehyde
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Spectrophotometry
9
-
Description
-
Glutathione
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Spectrophotometry
10
-
Description
-
Total antioxidant capacity
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Spectrophotometry
11
-
Description
-
Systolic blood pressures
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Sphygmomanometer
12
-
Description
-
Diastolic blood pressure
-
Timepoint
-
Baseline and End-of-trial
-
Method of measurement
-
Sphygmomanometer
Intervention groups
1
-
Description
-
Intervention group: Selenium capsule, 200 µg, daily for 6 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo capsule, daily 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
-
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