Fish Oil Supplementation in Women With Gestational Diabetes

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02371343
• Other study ID #: SamiUlusCH
• Status: Unknown status
• Phase: N/A
• First received: February 19, 2015
• Last updated: February 24, 2015
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2015
• Source: Dr. Sami Ulus Children's Hospital
• Contact: Dilek Dilli, Assoc Prof
• Phone: +905422368250
• Email: dilekdilli2[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Gestational diabetes is the development of diabetes during pregnancy. According to the National Institutes of Health, gestational diabetes occurs in about 5 percent of all pregnancies in the United States, resulting in about 200,000 cases a year. Treatment involves dietary measures, exercise and, in some cases, insulin injections. All pregnant women should be taking a prescribed pre-natal vitamin, and should also supplement with fish oil or another source of omega-3 fatty acids to help support the nervous system of their developing child.

Left untreated, gestational diabetes and preeclampsia can lead to serious -- or even fatal -- complications for both mother and child. In diabetic pregnancies there is an increased risk of birth defects. 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. In general the omega-3 fatty acids found in fish help the cardiovascular system, the brain (including moods), and even the brain and eyes of a developing baby. The risk of pre-term delivery and low birth weight is three and a half times higher when mothers are deficient in DHA. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Abnormality
• Diabetes, Gestational
• Fetal Macrosomia
• Other Respiratory Problems After Birth

Intervention

Dietary Supplement:
• Fish oil, Ocean plus
Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, Germany
• Sunflower Oil

Locations

Country	Name	City	State
Turkey	Sami Ulus CH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

Outcome

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