Plasma Glucose Following Prolonged Heat ExposureNCT06982612
Glycemic Control Following Occupational Work in a Hot Environment
A study testing Hot environment and Temperate condition in people with Plasma Glucose Following Prolonged Heat Exposure, run by Loughborough University.
Trial summary
Occupational workers regularly perform physically demanding tasks in hot environments, exposing them to heat stress and potential dehydration. While the physiological impacts of heat exposure are well-documented, its effects on glycemic control remain less understood. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Glucose Following Prolonged Heat Exposure
- What is being tested?
- Hot environment and Temperate condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Generally fit and healthy
- Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week
Who cannot join
- Under 18 or 45 and over,
- any morbidity or medication that might influence carbohydrate/fat metabolism (i.e., liver/renal/cardiovascular disease) or cycling ability (musculoskeletal injury etc),
- coagulation or bleeding disorders,
- blood-borne illness,
- heart conditions,
- congenital heart disease,
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- uncontrolled exercise-induced asthma,
- smoking (including vaping),
- allergies to the products used in the study,
- dieting or restrained eating behaviours.
- Females with amenorrhea would be an exclusion criteria.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Occupational workers regularly perform physically demanding tasks in hot environments, exposing them to heat stress and potential dehydration. While the physiological impacts of heat exposure are well-documented, its effects on glycemic control remain less understood. Given the rising global temperatures due to climate change and the increasing prevalence of metabolic disorders such as obesity and type 2 diabetes, it is essential to investigate how heat exposure during work influences glycemic regulation. Understanding these interactions will help inform future occupational health guidelines and metabolic health recommendations in physically demanding industries.
- Being tested
- Hot environment, Temperate condition
- Keywords
- heat, plasma glucose, worker, glycemia, OGTT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot environmentOther
Participants exercising in a 36 degrees celsius environment
Temperate conditionOther
Participants exercising in a 18 degrees celsius environment
| Study group | Role | What they receive |
|---|---|---|
| Hot condition | Experimental | Light exercise in a hot environment with ad libitum water intake Receives: Other: Hot environment |
| Temperate condition | Experimental | Light exercise in a temperate environment with ad libitum water intake Receives: Other: Temperate condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Measured using colorimetric assay from venous blood samples
Measured: 8hours
Secondary outcomes (12)
Plasma insulin
Measured using ELISA from venous blood samples
Measured: 8hours
Plasma osmolality
Measured using freezing point depression from venous blood samples
Measured: 8hours
Plasma volume change
Determined from haemoglobin and haematocrit measures in blood samples
Measured: 8hours
Urine volume
Determined from urine samples collected before and after exercise
Measured: 8hours
Body mass
Determined from weighing participants before and after exercise
Measured: 8hours
Urine specific gravity/osmolality
Determined from urine samples collected before and after exercise
Measured: 8hours
Rectal temperature
Measured via rectal probe
Measured: 8hours
Blood pressure
Measured via and automated sphygmomanometer
Measured: 8hours
Respiratory gas exchanges
Measured via Douglas bag, gas content and volume
Measured: 8hours
Rate of perceived exertion
using Borg scales (from 6 [no effort] to 20 [maximal effort])
Measured: 8hours
Rate of thermal sensation
using -10 [cold] to +10 [hot] scale.
Measured: 8hours
Feelings of thirst, urge to urinate, GI comfort, and stomach bloatedness
using scales (0 = no feeling, 10 = extreme feeling)
Measured: 8hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startMay 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Glucose Following Prolonged Heat ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, crossover design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Mears, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982612
- Sponsor's protocol ID
- LEON21544
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control Following Occupational Work in a Hot Environment
- ClinicalTrials.gov ID
- NCT06982612
- Acronym / sponsor ID
- LEON21544
- Keywords
- heat, plasma glucose, worker, glycemia, OGTT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Occupational workers regularly perform physically demanding tasks in hot environments, exposing them to heat stress and potential dehydration. While the physiological impacts of heat exposure are well-documented, its effects on glycemic control remain less understood. Given the rising global temperatures due to climate change and the increasing prevalence of metabolic disorders such as obesity and type 2 diabetes, it is essential to investigate how heat exposure during work influences glycemic regulation. Understanding these interactions will help inform future occupational health guidelines and metabolic health recommendations in physically demanding industries.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, crossover design
| Arm | Type | Receives |
|---|---|---|
| Hot condition | Experimental | Other: Hot environmentLight exercise in a hot environment with ad libitum water intake |
| Temperate condition | Experimental | Other: Temperate conditionLight exercise in a temperate environment with ad libitum water intake |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female
- Generally fit and healthy
- Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week
Key exclusion criteria (11 listed)
- Under 18 or 45 and over,
- any morbidity or medication that might influence carbohydrate/fat metabolism (i.e., liver/renal/cardiovascular disease) or cycling ability (musculoskeletal injury etc),
- coagulation or bleeding disorders,
- blood-borne illness,
- heart conditions,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot environmentParticipants exercising in a 36 degrees celsius environment | Other | Hot condition |
| Temperate conditionParticipants exercising in a 18 degrees celsius environment | Other | Temperate condition |
Primary outcome
Plasma glucose
Time frame: 8hours
Measured using colorimetric assay from venous blood samples
12 secondary outcomes
Plasma insulin
Time frame: 8hours
Plasma osmolality
Time frame: 8hours
Plasma volume change
Time frame: 8hours
Urine volume
Time frame: 8hours
Body mass
Time frame: 8hours
Urine specific gravity/osmolality
Time frame: 8hours
Rectal temperature
Time frame: 8hours
Blood pressure
Time frame: 8hours
Respiratory gas exchanges
Time frame: 8hours
Rate of perceived exertion
Time frame: 8hours
Rate of thermal sensation
Time frame: 8hours
Feelings of thirst, urge to urinate, GI comfort, and stomach bloatedness
Time frame: 8hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Hot environment and Temperate condition in people with Plasma Glucose Following Prolonged Heat Exposure, run by Loughborough University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen A Mears, PhD (+44 1509 226391, s.a.mears@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (time frame: 8hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.