NCT05188027

Brief Summary

Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). One will be a moderate aerobic exercise session (30 minutes of exercise, 60 minutes of recovery), and the third will be a moderate weight-lifting session (\~30 minutes of exercise, 60 minutes of recovery).The investigators will measure changes in blood glucose during exercise by drawing blood during and after exercise. Post-exercise glucose trends will be examined using continuous glucose monitoring.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Nov 2021Mar 2027

Study Start

First participant enrolled

November 16, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5.4 years

First QC Date

December 8, 2021

Last Update Submit

March 12, 2026

Conditions

Type 1 DiabetesPost-menopause

Keywords

ExercisePhysical activity

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Change in blood glucose

    From 0 minutes to 45 minutes (beginning to the end of exercise/control) and then for 60 minutes after exercise

Secondary Outcomes (9)

  • mean continuous glucose monitoring (CGM) glucose

    6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise

  • coefficient of variation (CV) of CGM glucose

    6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise

  • standard deviation (SD)

    6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise

  • frequency of hypoglycemia

    6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise

  • frequency of hyperglycemia

    6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise

  • +4 more secondary outcomes

Study Arms (1)

All participants

EXPERIMENTAL

All participants will take part in all three testing conditions

Other: Aerobic ExerciseOther: Resistance ExerciseOther: No exercise

Interventions

Aerobic ExerciseOTHER

Walking at 60% of maximal aerobic capacity on a treadmill

All participants
Resistance ExerciseOTHER

Performing one set of 10 repetitions of 10 different weight-lifting exercises

All participants
No exerciseOTHER

Participants will rest in a supine position for 30 minutes.

All participants

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 1 diabetes, diagnosed for at least one year
  • post-menopause (at least one year since last menstrual period), or have had a hysterectomy and bilateral salpingo oophorectomy
  • able to perform aerobic and resistance exercise
  • able to visit the lab in Edmonton, Alberta (University of Alberta)

You may not qualify if:

  • HbA1c \> 9.9 %
  • frequent and unpredictable hypoglycemia
  • change in insulin management strategy within the last 2 months
  • blood pressure \> 140 / 95
  • severe peripheral neuropathy
  • history of cardiovascular disease
  • musculoskeletal injuries interfering with exercise performance
  • use of medications (other than insulin) that affect glucose metabolism
  • BMI \> 30 kg/m2
  • smoking
  • moderate to high alcohol intake (\> 2 drinks/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Central Study Contacts

Jane E Yardley, PhD

CONTACT

780-679-1688jane.yardley@ualberta.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 12, 2022

Study Start

November 16, 2021

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)