Chronic Passive Heating in Individuals With T2DM

NCT04858321 | Completed Results

• 1 other identifier: 006
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (16)

• Plasma Glucose Concentration

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

• Plasma eHSP70 Concentration

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

• Plasma IL-6 Concentration

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

• Plasma IL-10 Concentration

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

• Resting Metabolic Rate

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

Study Arms (1)

Passive heating

EXPERIMENTAL

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.

Procedure: Passive heating

Interventions

Passive heating PROCEDURE

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.

Passive heating

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

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

Results Point of Contact

• Title: Dr Anthony Shepherd
• Organization: University of Portsmouth

ant.shepherd@port.ac.uk

02392845289

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Lecturer in Physical Activity, Exercise and Health

Model Details: We plan to run a within-subject, pre-, post-intervention study

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 26, 2021
• Study Start: May 24, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)