Clinical trial NCT05256615: Exercise Timing and Gestational Diabetes
Official title: Optimizing Blood Glucose Control in Pregnant Women Diagnosed With Gestational and Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Diabetes
Diabete Mellitus
Type 2 Diabetes
Pre-diabetes
Exercise
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study comprises of two groups; a diabetes and a non-diabetes group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postprandial blood glucose (mmol/l)
timeFrame: Day 1 to Day 14
measure: Daily physical activity (minutes per day)
timeFrame: Day 1 to Day 14
measure: Sleep (minutes per night)
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Heart rate (bpm)
timeFrame: Day 3-7 and day 9-14
measure: Health history questionnaires
timeFrame: Pre-intervention
measure: Physical activity questionnaires
timeFrame: Pre-intervention
measure: Sleep quality questionnaire
timeFrame: Pre-intervention
measure: Food Diary
timeFrame: Days 1 - 14
measure: Maternal outcomes
timeFrame: Through study completion - an average of 1 year postpartum
measure: Infant outcomes
timeFrame: Through study completion - an average of 1 year postpartum
measure: Infant Apgar Scores
timeFrame: Through study completion - an average of 1 year postpartum
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: