NCT05203653

Brief Summary

Certain types and timings of exercise are known to cause hyperglycemia (high blood glucose) in people with type 1 diabetes. Hyperglycemia increases the risk of most long-term complications for individuals with this complication. However, using insulin corrections to treat post-exercise hyperglycemia can increase the risk of late-onset hypoglycemia (low-blood glucose). Anaerobic activities performed in a fasted state are known to cause increases in blood glucose and post-exercise hyperglycemia in most individuals with type 1 diabetes. This study proposes to examine the effect of a ten-minute aerobic cool down after resistance exercise on the blood glucose response to fasted exercise of individuals with type 1 diabetes. It is hypothesized that adding a short aerobic cool down at the end of a fasted resistance exercise session will attenuate post-exercise increases in blood glucose observed in previous studies, leading to less post-exercise hyperglycemia.

Trial Health

87
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
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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

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
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

January 10, 2022

Last Update Submit

March 27, 2023

Conditions

Type 1 Diabetes

Keywords

resistance exercise, aerobic exercise

Outcome Measures

Primary Outcomes (1)

  • percent time spent in hyperglycemia

    amount of time spent with interstitial glucose (measured by continuous glucose monitoring) greater than 9.9 mmol/L

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

Secondary Outcomes (6)

  • mean continuous glucose monitoring (CGM) glucose

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

  • frequency of hyperglycemia

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

  • frequency of hypoglycemia

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

  • percent time spent in hypoglycemia

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

  • percent time in range

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

  • +1 more secondary outcomes

Study Arms (1)

All participants

EXPERIMENTAL

All participants will undergo two separate testing sessions

Behavioral: Resistance exercise onlyBehavioral: Resistance exercise plus cool down

Interventions

Resistance exercise onlyBEHAVIORAL

Participants will perform 3 sets of 8 repetitions of 7 different exercises while in a fasted state.

All participants
Resistance exercise plus cool downBEHAVIORAL

Participants will perform 3 sets of 8 repetitions of 7 different exercises while in a fasted state followed by a 10-minute light aerobic cool down

All participants

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with type 1 diabetes for more than 12 months
  • using either multiple daily insulin injections or continuous subcutaneous insulin infusion
  • willing and able to perform resistance exercise
  • HbA1c \< 10.0%
  • ability to attend laboratory-based sessions at the University of Alberta in Edmonton

You may not qualify if:

  • 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.
  • treatment with medications (other than insulin) that affect glucose metabolism (e.g. atypical antipsychotics, corticosteroids)
  • 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)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

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

March 1, 2022

Primary Completion

March 19, 2023

Study Completion

March 19, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)