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临床试验/NCT01262781
NCT01262781已完成不适用

Is Fructose Linked to Adiposity in Babies?

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
% adiposity (DEXA)

研究概览

简要总结

The obesity epidemic has reached down into the infant and toddler age group. Dietary indiscretion during pregnancy, particularly in our current food environment, is a major risk factor for both gestational diabetes and neonatal macrosomia (>4kg newborns), which is itself a risk factor for obesity and metabolic syndrome in the offspring, possibly even during childhood. Temporal increases in fructose consumption in the last two decades coincide with temporal increases weight gain during pregnancy and with increased birth weight, including a higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.

详细描述

The "fetal origins hypothesis" suggests that an individual's risk for obesity and metabolic disorders begins in utero; that fetal or early postnatal exposure to environmental factors, such as maternal nutrition or endocrine disrupting chemicals, adversely influences early development and results in permanent changes affecting energy storage and expenditure.

Most studies on "fetal origins" of obesity in the offspring have focused on maternal high-fat diets; yet dietary fat consumption has not changed appreciably in the last two decades. One chemical exposure in both pregnant mothers and newborns that has been steadily increasing worldwide is fructose. Although ostensibly a carbohydrate, fructose is a potent lipogenic substrate, and in the hypercaloric state, as much as 30% of an ingested fructose load undergoes de novo lipogenesis to form triglyceride thus the effects of high-fat and high-fructose diets in terms of physiology and outcome are comparable. Substituting sucrose (fructose + glucose) for glucose alone increases visceral adiposity, insulin resistance, and dyslipidemia in adult animals and humans. For humans, fructose is ubiquitous in the food environment, especially for pregnant mothers, who are often counseled to drink juice during pregnancy, as it is deemed to be healthier than soda. The effects of fructose consumption during pregnancy on infant birth weight and adiposity has not yet been studied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Agreement to participate in all measurements
  • Plans to remain in the area through delivery
  • Ability to understand and give informed consent in either English or Spanish.

排除标准

  • Presence of diabetes prior to the index pregnancy
  • Presence of gestational diabetes during a previous pregnancy
  • Presence of diabetes or of other chronic metabolic disease such as cardiovascular disease, active thyroid disease, liver disease, pulmonary or psychiatric disorders, HIV
  • Any disorder requiring diet therapy (i.e., renal insufficiency)
  • Multiple gestation
  • Prior history of intrauterine growth retardation
  • Use of substances known to cause intrauterine growth retardation (e.g., smoking or drug use). -
  • Once recruited, any ultrasonographic evidence of intrauterine growth retardation during the course of the pregnancy would also lead to exclusion.

结局指标

主要结局

% adiposity (DEXA)

时间窗: After delivery, neonatal adiposity will be measured using DEXA. This part of the protocol takes place 4-5 months after recruitment.

After delivery, neonatal adiposity will be measured using DEXA.

次要结局

  • cord blood insulin (corrected by cord blood glucose)(At delivery (in the OR): 4-5 months after recruitment)
  • cord blood triglycerides(At delivery (in the OR): 4-5 months after recruitment)
  • cord blood leptin(At delivery (in the OR): 4-5 months after recruitment)
  • anthropometric measurements on the newborn(After delivery (4-5 months after recruitement))
  • cord blood uric acid(At delivery (in the OR): 4-5 months after recruitment)
  • fetal fractional thigh volume obtained by fetal ultrasound(At 32 weeks gestation (4 months after recruitment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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