Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Current estimates suggest 422 million people worldwide live with a form of diabetes, of which ~ 90% have type 2 diabetes mellitus (T2DM). The total direct and indirect cost of care for individuals with diabetes in the UK is £23.7 billion, equating to ~ 20% of the annual NHS budget, this figure is expected to rise to ~£39.8 billion by the year 2035. Approximately 85-90% of cases of T2DM arise from a poor lifestyle and obesity, with the remaining 10-15% resulting from genetic predispositions. Current interventions include pharmaceutical treatments, exercise and calorie restrictive diets, which aim to improve glycaemic control. However, pharmaceutical interventions carry a high financial cost, while exercise and diet programmes have a low adherence rate in individuals with T2DM. With the prevalence of T2DM continuing to increase, the costs associated with the clinical care of these individuals are likely to become unsustainable. Simple, inexpensive interventions to improve the clinical profile of this group are therefore needed. One emerging potential therapy to improve glucose homoeostasis is passive heating. Preliminary evidence suggests passive heating may have beneficial effects for metabolic health in animal models and in humans. In 1999, the use of hot tubs (38-41°C , 30 mins / day for 3 weeks) was shown to reduce fasting plasma glucose concentrations by ~14% (1.3 mmol.L-1) and decrease HbA1c by ~10-11 mmol/mol in 8 individuals with T2DM. Given the rate of turnover in haemoglobin this reduction is surprising as the treatment period was run over 3 weeks and the total haemoglobin turnover takes ~115 days. While more recent work has been conducted into the effects of a single bout of passive heating in healthy adults and individuals with T2DM (including ourselves, under review), none have been done on chronic heating since Hooper. Hooper postulated that an increase in skeletal muscle blood flow may be responsible for this increased glucose clearance, citing evidence that this can modulate insulin mediated glucose uptake. Other mechanisms have also been purported, but have yet to be elucidated, including; increased insulin sensitivity, altered inflammatory response, activation of heat shock proteins (HSP), altered gut microbiome and butyrate. Repeated passive heating results in transient increases in deep body temperature and may improve glucose homeostasis via similar mechanisms to exercise. Regular aerobic exercise also improves macro- and microvascular function, muscle oxygenation, autonomic function, cardiorespiratory fitness, lung function and delays age related muscle loss. Acute exercise studies show that insulin sensitivity after 1h of moderate exercise does not change, however, insulin sensitivity appears to be improved following bouts longer than an hour or performed at greater intensity. Increases in insulin sensitivity have a curvilinear relationship with energy expenditure and could also be due to greater HSP expression. However, it is unrealistic for people with T2DM to perform this level of activity. Passive heating may be one supplemental exercise mimetic to augment improvements in insulin sensitivity, cardiorespiratory fitness and muscle strength, and function. The investigators recently provided evidence that acute passive heating in poeple with T2DM (currently under review for publication) is well tolerated and increases extracellualr [HSP70], and energy expenditure, and reduce diabstolic blood pressure. There is a growing body of evdience that suggests passive heating may improve many facets of human physiology, however, the mechanisms that underpin these benefits have yet to be established and future research needs to explore these further. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858321
Study type Interventional
Source University of Portsmouth
Contact Anthony I Shepherd, PhD
Phone 02392845289
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 3, 2021
Completion date November 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03239366 - A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population Phase 2
Recruiting NCT04597229 - Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus N/A
Recruiting NCT03623139 - Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes N/A
Recruiting NCT04511325 - Effects of White Potato Consumption on Measures of Cardiometabolic Health in Individuals With Type 2 Diabetes Mellitus N/A
Recruiting NCT04599920 - Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life) N/A
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Recruiting NCT04382521 - A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions N/A
Recruiting NCT04564391 - Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins N/A
Recruiting NCT03458715 - The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin Phase 4
Terminated NCT03278236 - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? N/A
Completed NCT02974504 - Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN) Phase 4
Not yet recruiting NCT03659383 - The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine Phase 4
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Completed NCT03657537 - Effects of Ketone Bodies on Cognition in Type 2 Diabetes Phase 1
Completed NCT03979768 - Risk Assessment of Type 2 Diabetes in Pharmacies N/A
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Active, not recruiting NCT03290768 - Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) N/A
Recruiting NCT04088851 - "The Role of the Liver for Interorgan Metabolic Crosstalk in Type 2 Diabetes" N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Recruiting NCT03423108 - Exercise Dose-response for Diabetes in the Elderly N/A