N/A
N=17
Chronic Passive Heating in Individuals With T2DM
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04858321 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Insulin Sensitivity — 0.31; 0.33; 0.10; 0.10 AU
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Passive heating (Procedure)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Portsmouth
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
0.31; 0.33; 0.10; 0.10 | — |
| SECONDARY Plasma Glucose Concentration |
10.06; 9.95; 17.34; 16.84 | — |
| SECONDARY Plasma eHSP70 Concentration |
2435; 2524 | — |
| SECONDARY Plasma IL-6 Concentration |
5.60; 5.46 | — |
| SECONDARY Plasma IL-10 Concentration |
13.55; 12.50 | — |
| SECONDARY Resting Metabolic Rate |
1987; 1855 | — |
| SECONDARY Flow Mediated Dilation |
2.88; 2.45 | — |
| SECONDARY Cutaneous Vascular Conductance |
1.11; 0.81; 1.52; 2.06 | — |
| SECONDARY Resting Heart Rate |
67; 64 | — |
| SECONDARY Stroke Volume Index |
54.6; 49.4 | — |
| SECONDARY Cardiac Output Index |
3.57; 3.05 | — |
| SECONDARY TNF-alpha |
10.51; 10.15 | — |
| SECONDARY Butyric Acid |
285; 405 | — |
| SECONDARY SBP |
136; 127 | — |
| SECONDARY DBP |
81; 80 | — |
| SECONDARY MAP |
99; 95 | — |
| SECONDARY NOX |
74.5; 67.3 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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
- 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)
Data sourced from ClinicalTrials.gov (NCT04858321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.