NCT07341243

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 14, 2026

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 25, 2025

Last Update Submit

January 5, 2026

Conditions

Type 1 Diabetes (T1D)

Keywords

exerciseheat

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    change in blood glucose concentration

    Baseline pre exercise to end of exercise (40 minutes)

Secondary Outcomes (10)

  • Core temperature

    Baseline pre exercise to end of exercise (40 minutes)

  • Skin temperature

    Baseline pre exercise to end of exercise (40 minutes)

  • Free fatty acids

    Baseline pre exercise to end of exercise (40 minutes)

  • insulin

    Baseline pre exercise to end of exercise (40 minutes)

  • glucagon

    Baseline pre exercise to end of exercise (40 minutes)

  • +5 more secondary outcomes

Study Arms (2)

Temperate

ACTIVE COMPARATOR

40 minutes of moderate intensity continuous exercise at 20°C with 50% relative humidity

Behavioral: Exercise

Heat

EXPERIMENTAL

40 minutes of moderate intensity continuous exercise at 40°C with 50% relative humidity

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

exercise in the heat or temperate conditions

HeatTemperate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Matthew Cocks, PhD

CONTACT

447540191292m.s.cocks@ljmu.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 14, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 14, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

On request to PI

Locations

GB(1)