Fish Oil Supplementation in Women With Gestational Diabetes

February 24, 2015 updated by: Dilek Dilli, Dr. Sami Ulus Children's Hospital

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Ankara, Turkey, 06120
        • Sami Ulus CH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dilek Dilli, Assoc Prof, Teaching Assistant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

February 1, 2015

More Information

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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