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NCT04858321

Chronic Passive Heating in Individuals With T2DM

Completed NA Results posted Last updated 3 January 2025
What this trial tests

NA trial testing Passive heating in Type2 Diabetes in 17 participants. Completed in 19 December 2022.

Timeline
24 May 2021
Primary endpoint
19 December 2022
19 December 2022

Quick facts

Lead sponsorUniversity of Portsmouth
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment17
Start date24 May 2021
Primary completion19 December 2022
Estimated completion19 December 2022
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Portsmouth

Who can join

35 and older, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insulin Sensitivity Primary · Change from pre (day 1) - post 8-12 days of 1 hour of passive heating

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.

Fasting - pre
GroupValue95% CI
Passive Heating0.31± 0.03
Fasting - post
GroupValue95% CI
Passive Heating0.33± 0.04
Post-prandial - pre
GroupValue95% CI
Passive Heating0.10± 0.04
Post-prandial - post
GroupValue95% CI
Passive Heating0.10± 0.05
Plasma Glucose Concentration Secondary · pre - post following 8-12 days of 1 hour of passive heating

Does chronic passive heating reduce plasma \[glucose\]?

Fasting - pre
GroupValue95% CI
Passive Heating10.06± 4.51
Fasting - post
GroupValue95% CI
Passive Heating9.95± 4.58
Post-prandial - pre
GroupValue95% CI
Passive Heating17.34± 7.34
Post-prandial - post
GroupValue95% CI
Passive Heating16.84± 6.49
Plasma eHSP70 Concentration Secondary · pre - post following 8-12 days of 1 hour of passive heating

Does chronic passive heating increase plasma \[eHSP70\]?

Pre
GroupValue95% CI
Passive Heating2435± 984
Post
GroupValue95% CI
Passive Heating2524± 790
Plasma IL-6 Concentration Secondary · pre - post following 8-12 days of 1 hour of passive heating

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

Pre
GroupValue95% CI
Passive Heating5.60± 10.46
Post
GroupValue95% CI
Passive Heating5.46± 8.47
Plasma IL-10 Concentration Secondary · pre - post following 8-12 days of 1 hour of passive heating

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

Pre
GroupValue95% CI
Passive Heating13.55± 35.88
Post
GroupValue95% CI
Passive Heating12.50± 31.47
Resting Metabolic Rate Secondary · pre - post following 8-12 days of 1 hour of passive heating

Does chronic passive heating reduce plasma resting metabolic rate?

Pre
GroupValue95% CI
Passive Heating1987± 512
Post
GroupValue95% CI
Passive Heating1855± 380
Flow Mediated Dilation Secondary · pre - post following 8-12 days of 1 hour of passive heating

Does chronic passive heating improve macrovascular function? Measured via ultrasound

Pre
GroupValue95% CI
Passive Heating2.88± 1.81
Post
GroupValue95% CI
Passive Heating2.45± 1.56
Cutaneous Vascular Conductance Secondary · pre - post following 8-12 days of 1 hour of passive heating

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)

Insulin AUC - pre
GroupValue95% CI
Passive Heating1.11± 2.10
Insulin AUC - post
GroupValue95% CI
Passive Heating0.81± 0.99
ACh AUC - pre
GroupValue95% CI
Passive Heating1.52± 1.60
ACh AUC - post
GroupValue95% CI
Passive Heating2.06± 2.77
Resting Heart Rate Secondary · pre - post following 8-12 days of 1 hour of passive heating

Does chronic passive heating reduce resting heart rate?

Pre
GroupValue95% CI
Passive Heating67± 12
Post
GroupValue95% CI
Passive Heating64± 11
Stroke Volume Index Secondary · pre - post following 8-12 days of 1 hour of passive heating

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

Pre
GroupValue95% CI
Passive Heating54.6± 13.3
Post
GroupValue95% CI
Passive Heating49.4± 11.3
Cardiac Output Index Secondary · pre - post following 8-12 days of 1 hour of passive heating

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

Pre
GroupValue95% CI
Passive Heating3.57± 0.74
Post
GroupValue95% CI
Passive Heating3.05± 0.54
TNF-alpha Secondary · Pre- v post 8-12 1 h hot water immersions

TNF-alpha

Pre
GroupValue95% CI
Passive Heating10.51± 18.65
Post
GroupValue95% CI
Passive Heating10.15± 18.14

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. *Mechanisms of circular RNA in drug resistance of lung cancer: therapeutic targets, biomarkers, and future research directions.
    Tao X, Ke X, Xu G. · · 2025 · cited 1× · PMID 40410444 · DOI 10.1007/s12672-025-02713-x

Verify or expand the search:

Other trials of Passive heating

Trials testing the same drug.

Other recruiting trials for Type2 Diabetes

Currently open trials in the same condition.

Other University of Portsmouth trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing