跳至主要内容
临床试验/NCT02916667
NCT02916667Unknown不适用

Chrono Nutrition Intervention Program in Gestational Diabetes Mellitus

Rabin Medical Center0 个研究点目标入组 280 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
280
主要终点
Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight (+100 gr) compared to offspring of participants with GDM with lower Chrono Biological score.

研究概览

简要总结

Working hypothesis and aims:

To asses Chrono Biological factors during the third trimester of gestational diabetes melittus (GDM) with birth weight and related complications. The investigators hypothesize that participants with GDM pregnancies with higher Chrono Biologocal status will be ended with higher birth weight compared to participants with GDM pregnancies with lower status. In addition, the investigators hypothesize that the Chrono Nutritional intervention program will contribute to the reduction of the rate of birth weight above percentile 90 compared with the participants with GDM in the control group.

详细描述

Background: Many studies have linked pre-pregnancy obesity and the metabolic syndrome, with an increased risk of developing gestational diabetes mellitus (GDM). These factors are associate with increased risk of newborn obesity, insulin resistance and diabetes. Recently, studies have shown that the "Chrono-Biological" (CB) aspects need to be considered in this context. These factors are related to endogenous circadian clocks, which regulate many body functions depending upon cycle of light and darkness during a day of almost 24 hours. By tracks daily fluctuations in heart rate, blood pressure, hormone secretion and control of a variety of metabolic pathways. Factors that can affect the setting of the circadian clock may include; Change dark and light hours, consumptions of certain nutrients during the day and more.

Chronic rhythm disruption associated with the development of obesity, diabetes, and more. Factors such as "chrono-nutrition" (CN) have a significant impact on variations in circadian rhythms includes: meals program schedule, glucose, saturated fat, caffeine and alcohol intake, and the ratio of macronutrients. Intervention studies in adults who are obese and diabetes were able to reduce the impact of these disorders by changing the composition and schedule of meals that lead to weight loss and diabetes control. Moreover, Insomnia during pregnancy can be caused by disorders CB. Insomnia affects 30-40% of all pregnancies. Some sleep disorders can be worsening by pregnancy, particularly overweight. Currently, routine monitoring and treatment of women with GDM does not include screening for sleep disorders and CN factors.

Working hypothesis and aims: To asses CB factors during the third trimester of participants with GDM pregnancies with a weight of childbirth and related complications. The investigators hypothesize that participants with GDM pregnancies with higher CB status will be ended with higher birth weight compared to participants with GDM pregnancies with a lower status.

In addition, the investigators assume that the CN intervention program will contribute to reducing the rate of birth weight above the 90 percentile compared to control group.

Methods: In a prospective cohort study, n= 280, The investigators will review the obstetric outcomes and the impact of CB disorders and complications for mother and fetus, through questionnaires. In a clinical trial n=100, The investigators will assess the effect of CN intervention on birth weight in participants with GDM pregnancies.

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
Single (Participant)

入排标准

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

入选标准

  • GDM first screened in 24-32 week of prenancy
  • singleton pregnancy
  • GDM screened in "Rabin medical center"
  • signing an informed consent

排除标准

  • women with history of metabolic disorder such as dislipidemia, heart disease, cancer, type 1 diabetes, type 2 diabetes, hypertension, kidney disease,liver disease, thyroids disorder, cancer.
  • women with history of fertility drug therapy such as IVF or progsterone
  • women who work night shifts
  • women who work in air crew

结局指标

主要结局

Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight (+100 gr) compared to offspring of participants with GDM with lower Chrono Biological score.

时间窗: 2 year

次要结局

  • Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight above the 90 percentile compared to offspring of participants with GDM with lower Chrono Biological score.(2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoel Toledano

principal investigator

Rabin Medical Center

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