RecruitingNot ApplicableNCT07209930

Inter- and Intraindividual Variability of the Acute Glucose Response to Exercise in Healthy Adults and People Living With Type 1 Diabetes: A Cross-over Replicate Trial

Sponsor

University College Dublin

Enrollment

24 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Exercise Healthy Participants Type 1 Diabetes (T1D)Glucose Variability

Summary

The goal of this clinical trial is to investigate if blood glucose responses are similar between and within individuals in response to standardized exercise in adults with and without Type 1 diabetes. The main questions it aims to answer are: What is the reproducibility of acute glycaemic responses to exercise within and between subjects in adults living with Type 1 Diabetes and in healthy adults? What is the agreement between glucose levels obtained by continuous glucose monitor (CGM) and blood glucose monitor? Participants will cycle on a cycle ergometer or rest after consuming a standardized breakfast, while glucose levels are monitored by CGM and capillary blood sampling.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how much blood sugar levels vary between different exercise sessions — and between different people — in both healthy adults and adults with Type 1 diabetes. The goal is to understand why exercise affects blood sugar so differently each time and each person. **You may be eligible if...** - You are 18–60 years old - You are physically active at least once a week - For the Type 1 diabetes arm: you have had Type 1 diabetes for more than 18 months and can recognize when your blood sugar is low **You may NOT be eligible if...** - You have cardiovascular disease or a reason not to exercise - You have an active infection or inflammatory condition - You have chronic kidney or liver disease - You are pregnant or have gestational diabetes - You have a diagnosed eating disorder or another condition preventing participation - (Healthy arm): You have any type of diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise

After a 12h overnight fast, baseline measurements are collected. Participants are then provided with a standardized breakfast meal (60g carbohydrate). After consumption of the breakfast, participants remain seated seated for 30 minutes, before cycling on a cycle ergometer for 30 minutes at an intensity equivalent to 10% above the first ventilatory threshold (VT1). Sixty minutes of rest sitting on a chair will follow the 30-minute cycle. During the total 120 minute test, various measurements are collected at regular intervals, including: blood glucose measurements via finger prick, CGM measurements, RPE, HR, measures of heart rate variability (HRV) (RMSSD (Root Mean Square of Successive Differences) and SDNN (Standard Deviation of NN intervals)), and intensity of any hypoglycaemia-related symptoms using a Visual Analogue Scale (VAS).

OTHERRest

The procedure for the resting condition visits is identical to that of the exercise condition, with the only difference being that the 30-minute cycling session will be replaced by an additional 30 minutes of seated rest. This will ensure that the total duration of the session and the timing of all measurements will remain consistent across conditions.