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临床试验/NCT02371343
NCT02371343Unknown不适用

Effect of Fish Oil Supplementation in Women With Gestational Diabetes on Insulin Like Growth Factor-1 DNA Methylation in Newborns

Dr. Sami Ulus Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Birth size

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Fish-Oil

Active Comparator

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

干预措施: Fish oil, Ocean plus (Dietary Supplement)

Sunflower oil

Placebo Comparator

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

干预措施: Sunflower Oil (Dietary Supplement)

结局指标

主要结局

Birth size

时间窗: 1 year

Birth size of the newborns

次要结局

  • Insulin like growth factor DNA methylation(1 year)

研究者

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Dilli

Dilek Dilli, MD

Dr. Sami Ulus Children's Hospital

研究点 (1)

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