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临床试验/NCT05256615
NCT05256615已完成不适用

Optimizing Blood Glucose Control in Pregnant Women Diagnosed With Gestational and Type 2 Diabetes Mellitus.

University of Alberta2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年1月1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
41
试验地点
2
主要终点
Daily physical activity (minutes per day)

研究概览

简要总结

The aim of this study is to understand if the timing of exercise around food intake can help improve blood sugar management in pregnant individuals with diabetes.

详细描述

Between 3 - 20% of women develop gestational diabetes mellitus (GDM) during pregnancy, a condition in which blood sugar control is poor and can have serious health effects for both mom and baby. Women with GDM are at elevated risk of developing dangerously high blood pressure during pregnancy and type 2 diabetes later in life. GDM also puts the baby at an increased risk of excessive birth weight, low blood sugar at birth, and future risk of type 2 diabetes.

The 2019 Canadian Guideline for Physical Activity throughout Pregnancy recommends that women be physically active for at least 150 minutes spread over at least 3 days each week. Managing high blood sugars with exercise improves outcomes for mom and baby; however, optimal timing of exercise has not been investigated.

The goal of this study is to determine if exercising after meals in shorter bouts is more effective at controlling post-meal blood sugars than exercising in larger amounts between meals.

This is a fully remote study; participants will receive all necessary equipment in the mail and all interactions with the researcher will be done via phone, video call and email.

The study will recruit 30 pregnant women diagnosed (or not) with diabetes (gestational, pre-, or type 2 diabetes mellitus) after 20 weeks' gestation to participate in this 2-week study. Following a 2 day baseline period, they will be randomly assigned to: 1) walk for 10 minutes after each meal (SHORT), or 2) walk for 30 minutes once per day at any time except in the hour after eating (LONG) for 5 days. Following a 2- day washout period, women will then complete the alternative exercise protocol for an additional 5 days. Women will wear a Continuous Glucose Monitor to track blood sugars, and an accelerometer to track activity patterns (e.g., compliance to the intervention) for seven consecutive days. The Investigators hypothesize that women who walk for 10 minutes after each meal will have a blunted rise in blood sugar following food intake, compared to the women in the 30- minute walking group. Findings from this novel study may help better treat GDM, improving lifelong health for moms and babies around the world.

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

  • at least 18 years of age
  • singleton pregnancies
  • healthy pregnant individuals or diagnosed with gestational, pre- or Type 2 diabetes

排除标准

  • less than 18 years of age
  • presents with contraindications to prenatal exercise (e.g., preeclampsia)
  • multiple pregnancies (i.e. twins, triplets etc.)
  • currently taking Metformin

结局指标

主要结局

Daily physical activity (minutes per day)

时间窗: Day 1 to Day 14

All participants will be asked to wear an accelerometer (Actigraph wGT3X-BT Monitor, Actigraph LLC) for fourteen consecutive days to record 24-hour physical activity (min/d). This information will be collected to determine overall physical activity and movement behaviours (including light, moderate and vigorous activity intensity).

Postprandial blood glucose (mmol/l)

时间窗: Day 1 to Day 14

Mean, peak and nadir 24 hour daily glucose, glycemic variability, fasting glucose, time spent in hyperglycemia (\>10mmol/l), and time spent in hypoglycemia (\<3.5mmol/l). These values will be compared between pregnant individuals diagnosed with gestational, pre- or Type 2 diabetes, and healthy pregnant individuals. High postprandial glucose level indicates poor blood glucose control.

Sleep (minutes per night)

时间窗: Day 1 to Day 14

All participants will be asked to wear an accelerometer (Actigraph wGT3X-BT Monitor, Actigraph LLC) for fourteen consecutive nights to record 24-hour physical activity (min/d). This information will be collected to determine total sleep time (min/day)

次要结局

  • Sleep quality questionnaire(Pre-intervention)
  • Heart rate (bpm)(Day 3-7 and day 9-14)
  • Health history questionnaires(Pre-intervention)
  • Food Diary(Days 1 - 14)
  • Infant outcomes(Through study completion - an average of 1 year postpartum)
  • Infant Apgar Scores(Through study completion - an average of 1 year postpartum)
  • Physical activity questionnaires(Pre-intervention)
  • Maternal outcomes(Through study completion - an average of 1 year postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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