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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05188027
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Collaborator:
Women and Children's Health Research Institute, Canada
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Post-menopause Other: Aerobic Exercise Other: Resistance Exercise Other: No exercise Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acute Glycemic Effects of Aerobic and Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All participants Other: Aerobic Exercise
Walking at 60% of maximal aerobic capacity on a treadmill

Other: Resistance Exercise
Performing one set of 10 repetitions of 10 different weight-lifting exercises

Other: No exercise
Participants will rest in a supine position for 30 minutes.




Primary Outcome Measures :
  1. Blood glucose [ Time Frame: From 0 minutes to 45 minutes (beginning to the end of exercise/control) and then for 60 minutes after exercise ]
    Change in blood glucose


Secondary Outcome Measures :
  1. mean continuous glucose monitoring (CGM) glucose [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    mean of all measurements over the selected time frames

  2. coefficient of variation (CV) of CGM glucose [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    CV of CGM glucose over the selected time frames

  3. standard deviation (SD) [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    SD of CGM glucose over the selected time frames

  4. frequency of hypoglycemia [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    number of times that CGM glucose is equal to or less than 3.9 mmol/L

  5. frequency of hyperglycemia [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    number of times that CGM glucose is equal to or greater than 10.0 mmol/L

  6. percent time spent in hyperglycemia [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    percentage of time spent with CGM glucose equal to or greater than 10.0 mmol/L

  7. percent time spent in hypoglycemia [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    percentage of time spent with CGM glucose equal to or lower than 3.9 mmol/L

  8. percent time spent in range [ Time Frame: 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise ]
    percent of time spent with CGM glucose between 4.0 and 9.9 mmol/L

  9. carbohydrate supplementation [ Time Frame: from 0 minutes to 45 minutes (during exercise) ]
    grams of carbohydrate provided during exercise to prevent hypoglycemia



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05188027


Contacts
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Contact: Jane E Yardley, PhD 780-679-1688 jane.yardley@ualberta.ca

Locations
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Canada, Alberta
Alberta Diabetes Institute Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Jane E Yardley, PhD    7806791688    jane.yardley@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05188027    
Other Study ID Numbers: Pro00107673
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Exercise
Physical activity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases