Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT ID: NCT05188027

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Pre-test measures: Interested participants will be invited to either the Exercise Physiology laboratory the Augustana campus of the University of Alberta, or the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They will be asked questions related to menopause, PA levels, and medication. Blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. A blood sample will be drawn for assessment of HbA1c. Those who meet all eligibility criteria and complete informed consent forms will be asked to complete the initial exercise tests. Participants will perform a maximal aerobic capacity test with ECG monitoring, under the supervision of a certified exercise physiologist. Indirect calorimetry will be used to assess oxygen consumption and carbon dioxide production and will be used to extrapolate the participant's aerobic capacity. Participants will undergo a strength test for each of the ten exercises involved in the study, in order to estimate the their 1 repetition maximum. Participants will also be asked to undergo a dual energy x-ray absorptiometry (DXA) scan for body composition in the Clinical Research Unit at the Alberta Diabetes Institute. While this procedure generally requires proof of a negative pregnancy test, participants will be provided with a waiver in order to decline this test (in light of their menopausal status).

Testing sessions: Participants will be asked to arrive at the lab at around 4:00 pm for all three sessions, which will be randomly assigned. During the sessions, participants will be asked to perform one of the three activities: 1) seated rest 2) aerobic exercise (walking on a treadmill at 50% of the participant's pre-determined VO2max) or 3) resistance exercise consisting of 1 set of 10 repetitions of 10 different exercises with 90 seconds rest between sets. Blood samples will be drawn at baseline, after 10, 20 and 30 minutes of exercise, along with 30- and 60-minutes post-exercise via an IV catheter. Indirect calorimetry will be used to ensure that the participant is exercising at the appropriate intensity. Participants will be asked to match their daily food and insulin intake as closely as possible from one testing session to the next for the day before, day of and day after the testing session. The investigators will provide them with log sheets to assist in this task. They will also be asked to avoid strenuous exercise and alcohol intake.

A 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, or on the back of the arm of the participant, approximately 2 days prior to the first testing session. The Dexcom G6 CGM receiver will store glucose data every 5 minutes for up to 10 days. The participant will be instructed on how to remove their sensor at least 24 hours after the exercise session, and will be asked to return the receiver to enable the upload of their data to Dexcom Clarity by the study team.

Interviews: During the third and final testing session, study participants will be invited to answer questions about their study participation experience, exercise preferences, barriers to exercise, and other information they feel may improve their exercise experience. These interviews will be audio recorded and transcribed.

Conditions

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Type 1 Diabetes Post-menopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All participants

All participants will take part in all three testing conditions

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type OTHER

Walking at 60% of maximal aerobic capacity on a treadmill

Resistance Exercise

Intervention Type OTHER

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

No exercise

Intervention Type OTHER

Participants will rest in a supine position for 30 minutes.

Interventions

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Aerobic Exercise

Walking at 60% of maximal aerobic capacity on a treadmill

Intervention Type OTHER

Resistance Exercise

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

Intervention Type OTHER

No exercise

Participants will rest in a supine position for 30 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women and Children's Health Research Institute, Canada

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alberta Diabetes Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jane E Yardley, PhD

Role: CONTACT

780-679-1688

Facility Contacts

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Jane E Yardley, PhD

Role: primary

7806791688

Jane Yardley, PhD

Role: primary

Other Identifiers

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Pro00107673

Identifier Type: -

Identifier Source: org_study_id

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