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临床试验/NCT04051359
NCT04051359Unknown不适用

Effectiveness and Safety of Two Different Diets in Terms of Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
The rate of treatment failure defined as patients needing additional hypoglycemic therapy by long-insulin acting analogue detemir evaluated by capillary glucose levels

研究概览

简要总结

The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effective and safe for pregnant woman with GDM and safe for their offspring, when compared to the standard carbohydrate content diet.

详细描述

Increasing prevalence of obesity and tendency to become pregnant later in life can explain rising prevalence of gestation diabetes (GDM) (1). Diabetes in pregnancy is a major public health issue: it has been shown that the mother's glycemic levels correlates perfectly with child's birth weight, death in utero, perinatal mortality and hypoglycemia (2). Therapeutic management is relatively simple and based on correction of hyperglycemia by carbohydrate restriction and energy-controlled diet adapted to pre-pregnancy BMI (3).

Although restriction of dietary carbohydrate has been the cornstone for treatment of GDM (4,5) with ACOG and The Endocrine Society recommendation for carbohydrate intake to 33-40% of total daily calories, the paucity of RCT evidence supporting safety of carbohydrate restriction still exist and actual dietary composition that optimizes perinatal outcomes is unknown (3).

Carbohydrate restriction in GDM comes with the potential increases in dietary fat intake and consequently a strong association between maternal lipids (i.e., triglycerides and free fatty acids) and excess fetal growth (6). Moreover, restrictive caloric and carbohydrate diet increases ketogenesis and ketone bodies (acetoacetate and beta-hydroxybutyrate (BHB) cross well the placental barrier.

Gestational ketogenic diet in mouse deleteriously affects the offspring growth and brain development (7), an early postnatal exposure to a ketogenic diet results in significant alterations to neonatal brain structure and can be accompanied by functional and behavioral changes in later postnatal life (8).

In the second half of pregnancy, under the influence of increasing placental hormones and cytokine concentration, lipolysis become dominant and use of free fatty acids as the energy material for the mother's body in place of glucose that is consumed mostly by the fetus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages 18-45 years
  • GDM diagnosed between 12 and 34 weeks gestation according to Carpenter and Coustan criteria (13)
  • BMI 20-35 kg/m2
  • Singleton pregnancy
  • Willing to perform self-monitoring of blood glucose at least 4 times a day
  • Self-monitoring of blood glucose
  • 12 to 34 weeks of gestation at the time of randomization
  • Signed informed consent

排除标准

  • Pre-existing diabetes in pregnancy, including first trimester fasting glucose ≥105 mg/dL
  • Use of other oral hypoglycemic agents during this pregnancy
  • Multiple pregnancy
  • Known hepatic insufficiency (bilirubin >50 µmol/L and/or protrombin time <50 %)
  • Insufficient understanding
  • Participant in another investigational drug study at inclusion visits
  • Fetal malformation diagnosed by previous fetal ultrasound

研究组 & 干预措施

Standard carbohydrate (200 g) group

Active Comparator

Assignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the standard carbohydrate (200 g) group.

干预措施: Low carbohydrate (130 g) diet (Other)

Low carbohydrate (130 g) group

Experimental

Assignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the low carbohydrate (130 g) group.

干预措施: Low carbohydrate (130 g) diet (Other)

结局指标

主要结局

The rate of treatment failure defined as patients needing additional hypoglycemic therapy by long-insulin acting analogue detemir evaluated by capillary glucose levels

时间窗: From one week after inclusion : 13 to 36 weeks of gestation to delivery

o The treatment failure would be defined if the fasting SMBG would be ≥95 mg/dl and/or if 1-hour post-prandial (PP) BG would be ≥140 mg/dl or 2 hour PP BG would be ≥120 mg/dl in \>20% of the measurements

次要结局

未报告次要终点

研究者

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

michal roll

PA

Tel-Aviv Sourasky Medical Center

研究点 (2)

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