T-REX: Timing of Resistance Exercise in Type 1 Diabetes

Sponsor
Dasman Diabetes Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05884814
Collaborator
(none)
54
1
3
18
3

Study Details

Study Description

Brief Summary

The aims of the current study are

  1. to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes.

  2. to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Morning exercise
  • Behavioral: Afternoon exercise
  • Behavioral: Habitual physical activity levels
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1:1 parallel group design1:1:1 parallel group design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Timing of Resistance Exercise, Glucose Control and Exercise Adaptations in People With Type 1 Diabetes: a Randomised-controlled Trial
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Habitual physical activity

Behavioral: Habitual physical activity levels
Participants will be asked to maintain their normal activity levels

Active Comparator: Morning exercise

Exercise training between 6-10am

Behavioral: Morning exercise
Between 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)

Active Comparator: Afternoon exercise

Exercise training between 4-8pm

Behavioral: Afternoon exercise
Between 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)

Outcome Measures

Primary Outcome Measures

  1. Change in muscle strength [Change from baseline to 12 weeks]

    Sum of one repetition maximum for the 7 resistance exercise

  2. Change in interstitial glucose time in range [Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session]

    Interstitial glucose time in range (3.9-10mmol/L) measured via continuous glucose monitoring

Secondary Outcome Measures

  1. Change in appendicular skeletal muscle mass [Change from baseline to 12 weeks]

    Measured by DEXA

  2. Change in whole body fat mass [Change from baseline to 12 weeks]

    Measured by DEXA

  3. Change in physical function [Change from baseline to 12 weeks]

    Measured by the short performance physical battery

  4. Change in HbA1c [Change from baseline to 12 weeks]

    HbA1c concentration

  5. Change in interstitial glucose average [Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session]

    Interstitial average glucose measured via continuous glucose monitoring

  6. Change in interstitial glucose variability [Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session]

    Interstitial glucose variability measured via continuous glucose monitoring

  7. Change in interstitial glucose time in hypoglycaemia [Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session]

    Interstitial glucose time in range (<3.9mmol/L) measured via continuous glucose monitoring

  8. Change in interstitial glucose time in hyperglycaemia [Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session]

    Interstitial glucose time in range (>10mmol/L) measured via continuous glucose monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Physician confirmed type 1 diabetes for at least 1 year

  • Stable insulin therapy for 3 months prior to the study

Exclusion Criteria:
  • BMI of 45 or higher

  • BP of 160/100mmHg or higher

  • autonomic neuropathy

  • severe proliferative retinopathy

  • joint or limb injuries preventing weight-bearing activity

  • autonomic neuropathy

  • severe proliferative retinopathy

  • any other medical condition that prevents participants from exercising safely.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dasman Diabetes Institute Kuwait City Kuwait 15462

Sponsors and Collaborators

  • Dasman Diabetes Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
ClinicalTrials.gov Identifier:
NCT05884814
Other Study ID Numbers:
  • RA HM-2023-009
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2023