Timing of Resistance Exercise in Type 1 Diabetes (T-REX)

Timing of Resistance Exercise, Glucose Control and Exercise Adaptations in People With Type 1 Diabetes: a Randomised-controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Habitual physical activity levels; Behavioral: Morning exercise; Behavioral: Afternoon exercise

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebaa AlOzairi, MBChB; Phone Number: +965 22242999; Email: ebaa.alozairi@dasmaninstitute.rog

Study Locations

• Kuwait
  • Kuwait City, Kuwait, 15462
    • Recruiting
    • Dasman Diabetes Institute
    • Contact: Ebaa AlOZairi
    • Principal Investigator: Ebaa AlOzairi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle strength	Sum of one repetition maximum for the 7 resistance exercise	Change from baseline to 12 weeks
Change in interstitial glucose time in range	Interstitial glucose time in range (3.9-10mmol/L) measured via continuous glucose monitoring	Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in appendicular skeletal muscle mass	Measured by DEXA	Change from baseline to 12 weeks
Change in whole body fat mass	Measured by DEXA	Change from baseline to 12 weeks
Change in physical function	Measured by the short performance physical battery	Change from baseline to 12 weeks
Change in HbA1c	HbA1c concentration	Change from baseline to 12 weeks
Change in interstitial glucose average	Interstitial average glucose measured via continuous glucose monitoring	Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose variability	Interstitial glucose variability measured via continuous glucose monitoring	Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose time in hypoglycaemia	Interstitial glucose time in range (<3.9mmol/L) measured via continuous glucose monitoring	Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Change in interstitial glucose time in hyperglycaemia	Interstitial glucose time in range (>10mmol/L) measured via continuous glucose monitoring	Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session

Collaborators and Investigators

• Sponsor: Dasman Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: exercise; muscle; glucose control; circadian rhythm; strength
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RA HM-2023-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No