- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371343
Fish Oil Supplementation in Women With Gestational Diabetes
Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dilek Dilli, Assoc Prof
- Phone Number: +905422368250
- Email: dilekdilli2@yahoo.com
Study Contact Backup
- Name: Nazan Doğan, MD
- Phone Number: 6284 +903123055000
- Email: nazanneslihan@hotmail.com
Study Locations
-
-
-
Ankara, Turkey, 06120
- Sami Ulus CH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fish-Oil
The pregnants with gestational diabetes given fish oil: (Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, German) During third trimester of pregnancy, Once in a day |
Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, Germany
|
Placebo Comparator: Sunflower oil
The pregnants with gestational diabetes given sunflower oil: Sunflower oil capsules will be prepared in the pharmacy as the same size and colour with fish oil capsules During third trimester of pregnancy, Once in a day |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birth size
Time Frame: 1 year
|
Birth size of the newborns
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin like growth factor DNA methylation
Time Frame: 1 year
|
Insulin like growth factor DNA methylation
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dilek Dilli, Assoc Prof, Teaching Assistant
Publications and helpful links
General Publications
- 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: 10.1155/2014/368107. Epub 2014 Jun 2.
- 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;109(3):287-95. doi: 10.1042/CS20050028.
- Dilli D, Dogan NN, Ipek MS, Cavus Y, Ceylaner S, Dogan H, Dursun A, Kucukozkan T, Zenciroglu A. MaFOS-GDM trial: Maternal fish oil supplementation in women with gestational diabetes and cord blood DNA methylation at insulin like growth factor-1 (IGF-1) gene. Clin Nutr ESPEN. 2018 Feb;23:73-78. doi: 10.1016/j.clnesp.2017.12.006. Epub 2017 Dec 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SamiUlusCH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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