Timing of Resistance Exercise in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— T-REX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884814
• Other study ID #: RA HM-2023-009
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Dasman Diabetes Institute
• Contact: Ebaa AlOzairi, MBChB
• Phone: +965 22242999
• Email: ebaa.alozairi[@]dasmaninstitute.rog
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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)
• 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)
• Habitual physical activity levels
Participants will be asked to maintain their normal activity levels

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Kuwait City

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle strength	Sum of one repetition maximum for the 7 resistance exercise	Change from baseline to 12 weeks
Primary	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	Change in appendicular skeletal muscle mass	Measured by DEXA	Change from baseline to 12 weeks
Secondary	Change in whole body fat mass	Measured by DEXA	Change from baseline to 12 weeks
Secondary	Change in physical function	Measured by the short performance physical battery	Change from baseline to 12 weeks
Secondary	Change in HbA1c	HbA1c concentration	Change from baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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