Fetal Macrosomia Clinical Trial
Official title:
Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
Gestational diabetes is the development of diabetes during pregnancy. Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. Some evidence suggesting omega-3 fatty acids might help protect women from two serious pregnancy complications -- gestational diabetes and preeclampsia. Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA), help a pregnant woman give her developing baby every advantage in life starting in-utero. Recent studies suggested that the biologic processes underlying the observed associations may involve epigenetic changes, specifically DNA methylation. In this study the investigators aimed to examine the effect of fish oil supplementation in women with gestational diabetes mellitus on newborn outcomes and insulin like growth factor 1 DNA methylation.
Status | Unknown status |
Enrollment | 100 |
Est. completion date | September 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Women who were diagnosed as gestational diabetes mellitus (GDM) between 24 and 28th week of pregnancy - Women with GDM and accepted to be participate in the study - Women younger that 40 years old - The newborns of the women with GDM Exclusion Criteria: - The history of Type 1 diabetes melitus - Abnormal glucose tolerance <20th gestational week - The history of chronic illness in the mother - Women who eat fish <2 times in a week - Any history of sea-food allergy in the mother |
Country | Name | City | State |
---|---|---|---|
Turkey | Sami Ulus CH | Ankara |
Lead Sponsor | Collaborator |
---|---|
Dr. Sami Ulus Children's Hospital |
Turkey,
Guermouche B, Soulimane-Mokhtari NA, Bouanane S, Merzouk H, Merzouk S, Narce M. Effect of dietary n - 3 polyunsaturated fatty acids on oxidant/antioxidant status in macrosomic offspring of diabetic rats. Biomed Res Int. 2014;2014:368107. doi: 10.1155/2014 — View Citation
Soulimane-Mokhtari NA, Guermouche B, Yessoufou A, Saker M, Moutairou K, Hichami A, Merzouk H, Khan NA. Modulation of lipid metabolism by n-3 polyunsaturated fatty acids in gestational diabetic rats and their macrosomic offspring. Clin Sci (Lond). 2005 Sep — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Birth size | Birth size of the newborns | 1 year | |
Secondary | Insulin like growth factor DNA methylation | Insulin like growth factor DNA methylation | 1 year |
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