Timing of Resistance Exercise in Type 1 Diabetes

Study Overview
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Brief Summary
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The aims of the current study are to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes. to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Morning exercise
* Behavioral: Afternoon exercise
* Behavioral: Habitual physical activity levels


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1:1 parallel group design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Habitual physical activity | Behavioral: Habitual physical activity levels<br>* Participants will be asked to maintain their normal activity levels<br>|
| Active Comparator: Morning exercise<br>Exercise training between 6-10am | Behavioral: Morning exercise<br>* 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)<br>|
| Active Comparator: Afternoon exercise<br>Exercise training between 4-8pm | Behavioral: Afternoon exercise<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose control, exercise, circadian rhythm, muscle, strength