Exercise Timing and Gestational Diabetes

NCT05256615 | Completed

• 1 other identifier: Pro00097525
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Diabetes; Diabete Mellitus; Type 2 Diabetes; Pre-diabetes; Exercise

Outcome Measures

Primary Outcomes (3)

• Postprandial blood glucose (mmol/l)

  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.

  Day 1 to Day 14

• Daily physical activity (minutes per day)

  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).

  Day 1 to Day 14

• Sleep (minutes per night)

  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)

  Day 1 to Day 14

Secondary Outcomes (8)

• Heart rate (bpm)

  Day 3-7 and day 9-14

• Health history questionnaires

  Pre-intervention

• Physical activity questionnaires

  Pre-intervention

• Sleep quality questionnaire

  Pre-intervention

• Food Diary

  Days 1 - 14

Study Arms (2)

Diabetes

EXPERIMENTAL

Participants recruited to this arm have been clinically diagnosed with either gestational, pre- or type 2 diabetes.

Behavioral: 30-minute walking intervention; Behavioral: 10-minute

Non-diabetes

EXPERIMENTAL

Participants recruited to this arm of the study do not have gestational, pre- or type 2 diabetes.

Behavioral: 30-minute walking intervention; Behavioral: 10-minute

Interventions

30-minute walking intervention BEHAVIORAL

Participants are asked to go for a 30 minute walk once per day at any time except the 1 hour after a meal. During these walks they are asked to record heart rate using a heart rate monitor and a phone application.

Also known as: LONG

Diabetes; Non-diabetes

10-minute BEHAVIORAL

Participants are asked to go for a 10-minute walk after each meal occurring 3 times daily. During these walks they are asked to record heart rate using a heart rate monitor and a phone application.

Diabetes; Non-diabetes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Due to the topic of this study, this study targets female gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study comprises of two groups; a diabetes and a non-diabetes group.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 25, 2022
• Study Start: January 1, 2020
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)