To Bathe or Not to Bathe

NCT03798717 | Completed Results

• 1 other identifier: 003AS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Mean AUC (Area Under the Curve) Plasma [Glucose]

  Does an acute bout of passive, warm water therapy reduce plasma \[glucose\]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+...+(yn/2)).

  Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks

Secondary Outcomes (6)

• Change in Plasma [Insulin]

  Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks

• Mean Insulin Sensitivity

  Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks

• Change in Fuel Utilisation

  Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks

• Change in Cardiovascular Status

  Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks

• Change in eHSP70 (Extracellular Heat Shock Protein 70)

  Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks

Study Arms (3)

Control

NO INTERVENTION

Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.

Pre OGTT

EXPERIMENTAL

Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.

Diagnostic Test: Heating

Post OGTT

EXPERIMENTAL

Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.

Diagnostic Test: Heating

Interventions

Heating DIAGNOSTIC_TEST

Warm water immersion

Also known as: Bath

Post OGTT; Pre OGTT

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Portsmouth: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Department of Sport and Exercise Science

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Ant Shepherd
• Organization: University of Portsmouth

ant.shepherd@port.ac.uk

02392845289

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 10, 2019
• Study Start: February 20, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: July 21, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)