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临床试验/NCT04430439
NCT04430439已完成不适用

Postprandial Response to Emotion-Diet Interactions in Pregnancy

University of California, Irvine4 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
4
主要终点
Postprandial Glycemic Response With Stress Exposure

研究概览

简要总结

This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared to a less healthy meal (high GI).

详细描述

Maternal glucose-insulin homeostasis in pregnancy represents one of the most important physiological processes for maternal and child health outcomes. Although maternal diet is a key regulator of this process, its effects vary widely across individuals. Maternal stress could represent a moderator of considerable importance in this regard, yet little is known about the effects of stress on glycemic control in pregnancy and whether the effects of stress may vary as a function of diet quality. This project will investigate the effects of acute psychosocial stress exposure on the postprandial metabolic response to a meal of varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

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

  • English and/or Spanish speaking
  • 18-22 week's gestation
  • Pre-pregnancy BMI 25.0-39.9 kg/m2
  • Singleton, intrauterine pregnancy
  • Non-smoker
  • Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (<200 mg/dl)

排除标准

  • Non-fluency in English or Spanish
  • BMI <25.0 or ≥40.0 kg/m2
  • >22 week's gestation
  • multiple pregnancy
  • current smoker
  • present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities)
  • presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders
  • current psychiatric disorders or undergoing treatment/taking psychiatric medications
  • use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications
  • gestational diabetes mellitus or raised glucose result detected on the screening visit
  • unwilling to eat the standard breakfast meal at each laboratory visit

结局指标

主要结局

Postprandial Glycemic Response With Stress Exposure

时间窗: 2 weeks

Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)

Postprandial Glycemic Response Without Stress Exposure

时间窗: 2 weeks

Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition

Postprandial Glycemic Response With Stress Exposure

时间窗: 2 weeks

Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)

Postprandial Glycemic Response Without Stress Exposure

时间窗: 2 weeks

Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition

次要结局

  • Postprandial Insulin Response With Stress Exposure(2 weeks)
  • Postprandial Insulin Response Without Stress Exposure(2 weeks)
  • Postprandial Insulin Response With Stress Exposure(2 weeks)
  • Postprandial Insulin Response Without Stress Exposure(2 weeks)

研究者

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

Karen Lindsay

Assistant Professor

University of California, Irvine

研究点 (4)

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