NCT05168488

Brief Summary

This study proposes to examine the impact of time of day (morning versus afternoon) on the variability of blood glucose responses to high resistance exercise in a single group of patients with type 1 diabetes. Participants will be asked to wear a continuous glucose monitor during the 3 weeks of testing. During the six exercise sessions (three in the morning while fasted and three in the afternoon), participants will complete the same resistance exercise protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 16, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

November 22, 2021

Last Update Submit

January 3, 2024

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Capillary glucose (change during exercise)

    Using test strips and a hand-held glucometer to test blood from a finger poke

    0 minutes (exercise start), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes

Secondary Outcomes (8)

  • Mean CGM glucose

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

  • CGM coefficient of variation (CV)

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

  • CGM standard deviation (SD)

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

  • frequency of hypoglycemia

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

  • frequency of hyperglycemia

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

  • +3 more secondary outcomes

Study Arms (1)

All participants

EXPERIMENTAL

There is only one study arm consisting of all participants.

Behavioral: Fasted morning resistance exerciseBehavioral: Afternoon resistance exercise

Interventions

Fasted morning resistance exerciseBEHAVIORAL

On three separate occasions, participants will perform a standardized resistance exercise protocol in the morning while fasting.

All participants
Afternoon resistance exerciseBEHAVIORAL

On three separate occasions participants will perform a standardized resistance exercise protocol in the afternoon after eating their regular lunch

All participants

Eligibility Criteria

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

You may qualify if:

  • type 1 diabetes diagnosed for at least 1 year
  • aged 18 to 55 years

You may not qualify if:

  • HbA1c \> 9.9%
  • frequent and unpredictable hypoglycemia
  • change in insulin management strategy within two months of study
  • using closed-loop insulin delivery
  • injuries that would contraindicate resistance exercise
  • blood pressure \> 140/95
  • severe peripheral neuropathy
  • a history of cardiovascular disease
  • severe proliferative retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2R3, 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
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 23, 2021

Study Start

November 16, 2021

Primary Completion

December 16, 2023

Study Completion

December 16, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)