N/A
N=20
To Bathe or Not to Bathe
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03798717 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Mean AUC (Area Under the Curve) Plasma [Glucose] — 1677; 1797; 1662 AU
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heating (Diagnostic_test)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Portsmouth
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean AUC (Area Under the Curve) Plasma [Glucose] |
1677; 1797; 1662 | — |
| SECONDARY Change in Plasma [Insulin] |
75.18; 48.79; 79.86 | — |
| SECONDARY Mean Insulin Sensitivity |
52.00; 47.45; 56.51 | — |
| SECONDARY Change in Fuel Utilisation |
263; 278; 304 | — |
| SECONDARY Change in Cardiovascular Status |
— | — |
| SECONDARY Change in eHSP70 (Extracellular Heat Shock Protein 70) |
324; 507; 364 | — |
| SECONDARY Change in Inflammatory Status |
— | — |
Summary
Type 2 diabetes mellitus (T2DM) is characterised by chronic high blood sugar concentration (hyperglycaemia) and insulin resistance leading to a reduction in insulin sensitivity. These hyperglycaemic excursions can seriously impact metabolic, micro and macrovascular health. The total cost of the direct and indirect care of individuals with diabetes (~90% T2DM) in the UK (United Kingdom) is £23.7 billion, equating to ~20% of the annual national health service (NHS) budget, with this projected to become unsustainable. Low-cost interventions to improve glycaemic control in these individuals are therefore warranted. Current interventions include pharmaceuticals, exercise and calorie restrictive diets. Pharmaceutical interventions carry a high financial cost, while exercise and diet programmes have a low adherence rate in individuals with T2DM.
Heat therapy offers one potential low cost therapy. Immersion in a hot tub for 30 mins.day-1 for 10 days has been shown to reduce fasting plasma [glucose] and HbA1c in individuals with T2DM, which may be explained by acute (e.g. muscle) and chronic (e.g. reduced inflammatory status and increased heat shock proteins (HSP)) adaptations, although experimental evidence for these hypothesis are sparse. Other potential benefits include improved glycaemic control, insulin sensitivity, elevated resting metabolic rate and improved micro- and macrovascular function.
The aim of the present study is to determine whether acute hot water immersion can improve glucose tolerance in individuals with T2DM and whether it is more beneficial to undertake this before or after a OGTT (oral glucose tolerance test).
Eligibility Criteria
The participants must meet all of the following criteria to be considered eligible for the study:
- Male or female (either post-menopausal or in the early-follicular phase (3-5 days after the onset of menstruation) of the menstrual cycle), aged 35 years or above.
- Diagnosed with T2DM as defined by the WHO (World Health Organisation).
- 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
The participant may not enter / be withdrawn from the study if any of the following apply:
- 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.
- Any skin conditions including ulcerations
Data sourced from ClinicalTrials.gov (NCT03798717). 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.