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N/A N=17 Other

Chronic Passive Heating in Individuals With T2DM

Type2 Diabetes

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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