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Completed

NCT Number: NCT05168488

Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes

This study proposes to examine the impact of time of day (morning versus afternoon) on the variability of blood glucose responses to high resistance exercise in a single group of patients with type 1 diabetes. Participants will be asked to wear a continuous glucose monitor during the 3 weeks of testing. During the six exercise sessions (three in the morning while fasted and three in the afternoon), participants will complete the same resistance exercise protocol.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

About this study

Pre-test measures: Interested participants will be invited to the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They will be asked questions related to their physical activity levels and medication, and blood pressure will be measured to assess their eligibility. Where participants are eligible, anthropometric characteristics will be measured using standard protocols, as will blood pressure. A blood sample will be drawn for assessment of HbA1c. Participants will be introduced to the weight lifting equipment and the proper lifting techniques associated with each exercise prior to performing a standardized test to determine the maximum weight they can safely lift eight times while maintaining proper form (8 repetition maximum - 8RM).

Testing sessions: Participants will be asked to arrive at the lab either between 7 and 8 am in a fasting state, or between 4 pm and 5 pm. The three morning and three afternoon testing sessions will have identical exercise protocols. Participants will be asked to perform three sets of eight repetitions of seven different exercises (bench press leg press, shoulder press, leg curl, lat pulldown, abdominal crunches, seated row) at their pre-determined 8RM. Participants will be asked to match their food and insulin intake as closely as possible on testing days to avoid having these as confounders.

A continuous glucose monitor (CGM) sensor will be subcutaneously inserted by one of the investigators (trained by a group from the CGM manufacturer) into the anterior abdominal area of the participant in the morning of the day prior to the first testing session. CGM will store glucose data every 5 minutes for up to 7 days. During this time, participants will be asked to wear an accelerometer to allow for the objective assessment of background physical activity and sleep quality. Along with this device, they will fill out an activity and sleep log to improve the analysis of the data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes diagnosed for at least 1 year
  • aged 18 to 55 years

Exclusion criteria

  • HbA1c > 9.9%
  • frequent and unpredictable hypoglycemia
  • change in insulin management strategy within two months of study
  • using closed-loop insulin delivery
  • injuries that would contraindicate resistance exercise
  • blood pressure > 140/95
  • severe peripheral neuropathy
  • a history of cardiovascular disease
  • severe proliferative retinopathy

Treatment and study plan

Fasted morning resistance exercise

Behavioral

On three separate occasions, participants will perform a standardized resistance exercise protocol in the morning while fasting.

Afternoon resistance exercise

Behavioral

On three separate occasions participants will perform a standardized resistance exercise protocol in the afternoon after eating their regular lunch

Primary outcomes

  1. Capillary glucose (change during exercise)

    Time frame: 0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes

    Using test strips and a hand-held glucometer to test blood from a finger poke

Secondary outcomes

  1. Mean CGM glucose

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    mean CGM glucose

  2. CGM coefficient of variation (CV)

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    coefficient of variation of continuous glucose monitoring data

  3. CGM standard deviation (SD)

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    Standard deviation of CGM glucose

  4. frequency of hypoglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    number of hypoglycemic events measured by CGM

  5. frequency of hyperglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    number of hyperglycemic events measured by CGM

  6. percent time in range

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    percent of time spent between 4.0 and 9.9 mmol/L

  7. percent time in hyperglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    percent of time spent over 10.0 mmol/L

  8. percent time in hypoglycemia

    Time frame: 6 hours, 12 hours, overnight (midnight to 6am) and 24 hours post-exercise

    percent of time spent below 3.9 mmol/L

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

Repeatability of Blood Glucose Responses to Fasted and Fed Resistance Exercise in Individuals With Type 1 Diabetes

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2021
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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