NCT05203640

Brief Summary

Regular physical activity has substantial health benefits in people with type 1 diabetes. The fear of hypoglycemia, both during and after exercise, is a major barrier to exercise in this population. A major obstacle to providing specific physical activity and exercise advice is that there are still significant gaps in the fundamental understanding of the impact of physical activity and exercise on blood glucose levels in type 1 diabetes. Women with type 1 diabetes have a substantial increase in cardiovascular risk once they have passed menopause. They may lose both bone quality and muscle mass at a faster rate with aging than those without diabetes. Overall, these changes greatly increase the risk of both cardiovascular and frailty related complications. Despite the many potential benefits of resistance exercise for post-menopausal women with type 1 diabetes, there are currently no published studies examining the effects of resistance exercise in this population. Before being able to design a clinical trial of resistance exercise, an examination of the acute effects of resistance exercise on blood glucose levels in post-menopausal women with type 1 diabetes is required. The present study will compare the glycemic effects of a low resistance, high repetition (3 sets of 15 to 20 repetitions) weight lifting program to the effects of a moderate resistance, moderate repetition (3 sets of 8 to 10 repetitions). The investigators hypothesize that the high repetition program will be associated with a bigger decline in blood glucose during exercise, but that the moderate resistance program will be associated with a higher risk of post-exercise hypoglycemia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2022Sep 2026

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

4.2 years

First QC Date

January 10, 2022

Last Update Submit

July 4, 2025

Conditions

Keywords

resistance exercise

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Change in blood glucose during and after exercise

    from 0 minutes to 45 minutes, and from 45 minutes to 105 minutes

Secondary Outcomes (9)

  • Mean continuous glucose monitoring (CGM) glucose

    0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise

  • coefficient of variation (CV)

    0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise

  • standard deviation (SD)

    0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise

  • frequency of hypoglycemia

    0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise

  • frequency of hyperglycemia

    0 to 6 hours post exercise, overnight post exercise (midnight to 6 am) and 24 hours post exercise

  • +4 more secondary outcomes

Study Arms (1)

All participants

EXPERIMENTAL

All participants will be in a single arm that undergoes two separate interventions. These interventions will include a high repetition, low resistance protocol, and a moderate repetition, moderate intensity protocol.

Behavioral: High repetition (HI)Behavioral: Moderate repetition (MOD)

Interventions

Participants will perform 15 to 20 repetitions of 7 different exercises at 50% of their one repetition maximum

All participants

Participants will perform 8 to 10 repetitions of 7 different exercise at 75-80% of their one repetition maximum

All participants

Eligibility Criteria

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

You may qualify if:

  • female
  • type 1 diabetes diagnosed for at least 1 year
  • at least 12 months since last menstrual period
  • physically able and willing to perform resistance exercise
  • HbA1c \< 10%
  • residing near Edmonton, Alberta / able to attend laboratory based sessions at the University of Alberta

You may not qualify if:

  • Individuals with HbA1c \>9.9%
  • Frequent and unpredictable hypoglycaemia
  • A change in insulin management strategy within two months of the study
  • Blood pressure \> 144/95,
  • Severe peripheral neuropathy,
  • A history of cardiovascular disease
  • Musculoskeletal injuries affecting the ability to perform resistance exercise.
  • Individuals who are treated with medications (other than insulin) that affect glucose metabolism (e.g. atypical antipsychotics, corticosteroids)
  • A body mass index \>30kg/m2,
  • Smoking
  • Moderate to high alcohol intake (\>2 drinks per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jane Yardley, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

April 1, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations