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Recruiting NCT07341243

Exercising in Hot Conditions: How Does it Effect Blood Glucose in People With T1D

No phase Interventional Type 1 Diabetes (T1D)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Acute Heat Exposure on Glucose Use During Moderate-intensity Exercise in People With Type 1 Diabetes

Overview

A randomised, crossover, counterbalanced repeated measures study will be conducted to examine the effect of acute heat exposure on rate of change in blood glucose concentration during 40 minutes of moderate-intensity exercise and for 30 minutes after exercise. Participants will complete two experimental conditions during two separate laboratory visits, with the order of conditions randomised. One condition will be a temperate condition of 20°C with 50% relative humidity (Temperate), the other will be 40°C with 50% relative humidity (Heat). Visits will be identical, including time of day, except for the condition. Visits will be separated by 24h. Testing will take place in the laboratories of the Research Institute for Sport and Exercise Sciences at Liverpool John Moores University.

Interventions

  • Behavioral Exercise
    exercise in the heat or temperate conditions

Primary outcome measures

  • blood glucose [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
Secondary outcome measures (10)
  • Core temperature [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • Skin temperature [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • Free fatty acids [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • insulin [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • glucagon [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • epinephrine [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • norepinephrine [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • cortisol [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • Growth hormone [Time frame: Baseline pre exercise to end of exercise (40 minutes)]
  • lactate [Time frame: Baseline pre exercise to end of exercise (40 minutes)]

Eligibility criteria

Inclusion criteria

  • T1D diagnosis more than 1 years ago (to ensure participants are out of the honeymoon period)
  • Using insulin therapy with multiple daily injections (MDI), insulin pump (pump), or hybrid closed-loop (HCL)

o If using a HCL system have experience of using a pre-programmed basal rate in manual mode during exercise

  • Aged 18-65 years
  • Regularly engaged in endurance exercise (training at least twice per week for ≥30 minutes per session)

Exclusion criteria

  • Pregnancy
  • <6 months postpartum or stopped breastfeeding <1 month before recruitment
  • Existing cerebrovascular or cardiovascular disease
  • Significant history of hyperglycaemia (HbA1c >85 mmol/mol)
  • History of severe hypoglycaemia requiring third party assistance within the last 3 months
  • Body weight <36.5kg
  • Difficulty swallowing tablets
  • Appointment for an MRI test that cannot be rescheduled
  • Obstructive gastrointestinal disease
  • History of gastrointestinal surgery
  • Have an implanted medical device

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • Liverpool John Moores University — Liverpool

Identifiers

NCT: NCT07341243 · 25/SPS/065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗