Objective: The aim of this study is to determine the effects of magnesium and omega-3 supplementation on insulin resistance and inflammatory factor in gestational diabetes. Study design: Double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 120 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive magnesium supplement (n=30), omega-3 supplement (n=30), placebo for magnesium (n=30) and placebo for omega-3 (n=30). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles and inflammatory factor. Start and End Date of Intervention: 2 months (December 24, 2013- February 24, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin and hs-CRP levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312265623N16
Registration date:2014-03-10, 1392/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2014-03-10, 1392/12/19
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-02-14, 1392/11/25
Expected recruitment end date
2014-04-15, 1393/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium supplementation on insulin resistance and inflammatory factors in women with gestational diabetes
Public title
The effect of magnesium in the treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with pre-eclampsia; complete bed rest (CBR); intra uterine fetal death (IUFD); placenta abruption; preterm delivery.