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Type2 DiabetesNCT04858321

Chronic Passive Heating in Individuals With T2DM

A study testing Passive heating in people with Type2 Diabetes, run by University of Portsmouth at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type 2 diabetes mellitus (T2DM) is a metabolic condition characterized by chronic hyperglycemia and progressive insulin resistance, which progressively lead to macro- and microvascular damage and subsequent impairments in blood pressure (BP) control. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Type2 Diabetes
What is being tested?
Passive heating
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited Kingdom
Study dates
24 May 2021to 19 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female (post-menopausal) aged 35 years or above.
  • Diagnosed with T2DM as defined by the WHO (≥48 mmol/mol).
  • Participant is willing and able to give informed consent for participation in the study.
  • Participant is able to understand and fully cooperate with the study protocol.

Who cannot join

  • Severe peripheral neuropathy (to the point to which they cannot sense temperature)
  • Uncontrolled hypertension (≥180 systolic / 100 diastolic mmHg)
  • Taking any medication which may interfere with data interpretation or safety
  • Who have had a myocardial infarction or cerebro-vascular event
  • Any cardiac abnormalities which restrict hard exercise
  • Current smokers or who have stopped within 3 months
Show all 12Show fewer
  • Participant is unable to understand and/or fully cooperate with the study protocol
  • Any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
  • Skin ulcerations
  • Eczema
  • Pre-existing postural hypertension
  • Existing cardiac diseases (identified during screening)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Department of Sport and Exercise Science

    Portsmouth, Hampshire, PO1 2ER

Other trials in United Kingdom

About this study

Official title: The Effect of Chronic Passive Heating on Insulin Sensitivity and Cardiovascular Function in People With Type 2 Diabetes Mellitus: A Pre- and Post-test Trial

Type 2 diabetes mellitus (T2DM) is a metabolic condition characterized by chronic hyperglycemia and progressive insulin resistance, which progressively lead to macro- and microvascular damage and subsequent impairments in blood pressure (BP) control. Therapeutic approaches to manage T2DM focus on improving glycaemic control and BP and include pharmaceutical treatments (e.g. Metformin and insulin), physical activity and exercise, and calorie restriction. However, pharmaceutical interventions can be expensive and are associated with low adherence. Although exercise and diet programs have been shown to be effective, like pharmaceutical interventions, they often have poor adherence in people with T2DM. With the number of people with T2DM (464 million) continuing to rise and expected to reach 700 million by 2045, the costs associated with the clinical management of this condition are likely to become unsustainable. There is, therefore, a need to explore the potential of alternative interventions. In particular, interventions which may be cheaper than clinical management and have better adherence than exercise, and hypoglycemic agents, to improve glycemic control and deleterious cardiovascular manifestations of this condition.

Passive heating may be one such intervention with therapeutic potential.

Read the detailed description

Current estimates suggest 422 million people worldwide live with a form of diabetes, of which ~ 90% have type 2 diabetes mellitus (T2DM). The total direct and indirect cost of care for individuals with diabetes in the UK is £23.7 billion, equating to ~ 20% of the annual NHS budget, this figure is expected to rise to ~£39.8 billion by the year 2035. Approximately 85-90% of cases of T2DM arise from a poor lifestyle and obesity, with the remaining 10-15% resulting from genetic predispositions. Current interventions include pharmaceutical treatments, exercise and calorie restrictive diets, which aim to improve glycaemic control. However, pharmaceutical interventions carry a high financial cost, while exercise and diet programmes have a low adherence rate in individuals with T2DM. With the prevalence of T2DM continuing to increase, the costs associated with the clinical care of these individuals are likely to become unsustainable. Simple, inexpensive interventions to improve the clinical profile of this group are therefore needed.

One emerging potential therapy to improve glucose homoeostasis is passive heating. Preliminary evidence suggests passive heating may have beneficial effects for metabolic health in animal models and in humans. In 1999, the use of hot tubs (38-41°C , 30 mins / day for 3 weeks) was shown to reduce fasting plasma glucose concentrations by ~14% (1.3 mmol.L-1) and decrease HbA1c by ~10-11 mmol/mol in 8 individuals with T2DM. Given the rate of turnover in haemoglobin this reduction is surprising as the treatment period was run over 3 weeks and the total haemoglobin turnover takes ~115 days. While more recent work has been conducted into the effects of a single bout of passive heating in healthy adults and individuals with T2DM (including ourselves, under review), none have been done on chronic heating since Hooper. Hooper postulated that an increase in skeletal muscle blood flow may be responsible for this increased glucose clearance, citing evidence that this can modulate insulin mediated glucose uptake. Other mechanisms have also been purported, but have yet to be elucidated, including; increased insulin sensitivity, altered inflammatory response, activation of heat shock proteins (HSP), altered gut microbiome and butyrate. Repeated passive heating results in transient increases in deep body temperature and may improve glucose homeostasis via similar mechanisms to exercise.

Regular aerobic exercise also improves macro- and microvascular function, muscle oxygenation, autonomic function, cardiorespiratory fitness, lung function and delays age related muscle loss. Acute exercise studies show that insulin sensitivity after 1h of moderate exercise does not change, however, insulin sensitivity appears to be improved following bouts longer than an hour or performed at greater intensity. Increases in insulin sensitivity have a curvilinear relationship with energy expenditure and could also be due to greater HSP expression. However, it is unrealistic for people with T2DM to perform this level of activity. Passive heating may be one supplemental exercise mimetic to augment improvements in insulin sensitivity, cardiorespiratory fitness and muscle strength, and function.

The investigators recently provided evidence that acute passive heating in poeple with T2DM (currently under review for publication) is well tolerated and increases extracellualr [HSP70], and energy expenditure, and reduce diabstolic blood pressure. There is a growing body of evdience that suggests passive heating may improve many facets of human physiology, however, the mechanisms that underpin these benefits have yet to be established and future research needs to explore these further.

Conditions
Type2 Diabetes
Being tested
Passive heating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive heatingProcedure or surgery

    8-12 x1 h water immersion (to the clavicle, @40 °C, rectal temperature ~38.5 °C and <39 °C) sessions over a period of 14 days.

Study groups in NCT04858321
Study groupRoleWhat they receive
Passive heatingExperimental8-12 x1 h water immersion (to the clavicle, @40 °C, rectal temperature ~38.5 °C and <39 °C) sessions over a period of 14 days.
Receives: Procedure: Passive heating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin Sensitivity

    Does chronic passive heating improve insulin sensitivity? Calculated using the QUICKI for fasting and Gutt for post-prandial, with glucose and insulin concentrations. A higher value means they have better insulin sensitivity.

    Measured: Change from pre (day 1) - post 8-12 days of 1 hour of passive heating

Secondary outcomes (16)
  1. Plasma Glucose Concentration

    Does chronic passive heating reduce plasma [glucose]?

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  2. Plasma eHSP70 Concentration

    Does chronic passive heating increase plasma [eHSP70]?

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  3. Plasma IL-6 Concentration

    Does chronic passive heating reduce plasma [IL-6]?

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  4. Plasma IL-10 Concentration

    Does chronic passive heating increase plasma [IL-10]?

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  5. Resting Metabolic Rate

    Does chronic passive heating reduce plasma resting metabolic rate?

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  6. Flow Mediated Dilation

    Does chronic passive heating improve macrovascular function? Measured via ultrasound

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  7. Cutaneous Vascular Conductance

    Does chronic passive heating improve microvascular function? Assessed via iontophoresis or the forearm with ACh and Insulin, Area under the curve is the unit. (CVC = skin flux/MAP; flux/mmHg-1)

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  8. Resting Heart Rate

    Does chronic passive heating reduce resting heart rate?

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  9. Stroke Volume Index

    Does chronic passive heating increase stroke volume? Measured noninvasively via thoracic impedance

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  10. Cardiac Output Index

    Does chronic passive heating increase cardiac output? Measured noninvasively via thoracic impedance. L/min/m2 is the unit.

    Measured: pre - post following 8-12 days of 1 hour of passive heating

  11. TNF-alpha

    TNF-alpha

    Measured: Pre- v post 8-12 1 h hot water immersions

  12. Butyric Acid

    Butyric acid

    Measured: Pre- v post 8-12 1 h hot water immersions

  13. SBP

    Systolic blood pressure

    Measured: Pre- v post 8-12 1 h hot water immersions

  14. DBP

    Diastolic blood pressure

    Measured: Pre- v post 8-12 1 h hot water immersions

  15. MAP

    Mean arterial pressure

    Measured: Pre- v post 8-12 1 h hot water immersions

  16. NOX

    Nitrates + nitrites

    Measured: Pre- v post 8-12 1 h hot water immersions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start24 May 2021
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
We plan to run a within-subject, pre-, post-intervention study
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04858321
Sponsor's protocol ID
006
Status last verified
Nov 2024
First submitted
14 Apr 2021
Last updated
3 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to release IPD, until all avenues of further funding have been exhausted.

Questions about this trial

What is this clinical trial studying?

A study testing Passive heating in people with Type2 Diabetes, run by University of Portsmouth at 1 site in United Kingdom.

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 4 inclusion and 12 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: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Sensitivity (time frame: Change from pre (day 1) - post 8-12 days of 1 hour of passive heating). 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 3 Jan 2025.

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