Heat Therapy and Strength Training Effects in Individuals With Type 2 Diabetes

NCT05847075 | Unknown DMC

• 1 other identifier: 38626420.6.0000.5347
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare different non-pharmacological interventions in Type 2 diabetic people, testing their efficiency to improve metabolism and inflammation. The investigators will compare the effects of Heat Therapy (HT) and Strength training (ST), for 12 weeks, to test which one is more effective to improve participants health. Heat Therapy consists in submitting a person to an environmental chamber, initially set at 55 degrees Celsius on three non-consecutive days of the week. Each session will last 60 min. ST consists in supervised exercise in a gym on three non-consecutive days of the week. Each session will last \~60 min and will consist of a warm up, the resistance training and a cool down. All sessions will be conducted by qualified sport and exercise scientists for 12 weeks. A third group of people will stay sedentary without any other intervention for 12 weeks. Before, and after the end of the intervention blood samples will be collected to analyze metabolic parameters as well as inflammatory markers. The investigators hypothesize that ST and HT will reduce HbA1c levels, improve metabolic and inflammatory profile, dysbiosis, and the anti-inflammatory heat shock response (HSR).

Conditions

Type 2 Diabetes

Keywords

Heat Therapy; Inflammation; Metabolism; Microbiota; Diabetes

Outcome Measures

Primary Outcomes (1)

• Plasma HSP72

  Plasma concentration (in ng/mL) of HSP72.

  First visit, prior to the intervention (baseline) AND 2 weeks of intervention.

Secondary Outcomes (9)

• Fasting glucose

  First visit, prior to the intervention (baseline) AND 12 weeks of intervention.

• Insulin plasma concentration

  First visit, prior to the intervention (baseline) AND 12 weeks of intervention.

• Insulin resistance (HOMA-IR)

  First visit, prior to the intervention (baseline) AND 12 weeks of intervention.

• Body Mass Index (kg·m-2)

  First visit, prior to the intervention (baseline) AND 12 weeks of intervention.

• Visceral adipose tissue (VAT)

  First visit, prior to the intervention (baseline) AND 12 weeks of intervention.

Study Arms (3)

Sedentary Diabetic people

EXPERIMENTAL

Sedentary people with Type 2 Diabetes.

Other: Sedentary Control

Heat Therapy

EXPERIMENTAL

Diabetic people allocated in Heat Therapy for 12 weeks.

Other: Heat Therapy

StrengthTraining

EXPERIMENTAL

Diabetic people allocated in Strength training for 12 weeks.

Other: StrengthTraining

Interventions

Heat Therapy OTHER

Participants in the HT group will undertake whole body heat treatment according to previous methods. Participants will be housed in an environmental chamber initially set at 55.0oC on three non-consecutive days of the week during 12 weeks. Each session will last 60 min.

Heat Therapy

StrengthTraining OTHER

Participants will perform supervised exercise in a gym on three non-consecutive days of the week. Each session will last \~60 min and will consist of a warm up, the resistance training and a cool down. All sessions will be conducted by qualified sport and exercise scientists for 12 weeks.

StrengthTraining

Sedentary Control OTHER

Participants will not receive any intervention during 12 weeks.

Sedentary Diabetic people

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of type 2 diabetes
• HbA1c levels were between 7.0% and 10%
• Sedentary
• Non-smoking
• Body mass index (BMI) between 18.5-39.9 kg/m2,
• No use of insulin.

You may not qualify if:

• Pregnancy or breastfeeding
• Under treatment with antibiotics or anti-inflammatory drugs within 4 weeks,
• History of cardiovascular diseases: myocardial infarction, cardiac illness, vascular disease, stroke, or any condition that would prevent them from engaging in an exercise study;
• Engaged in two or more planned and structured exercise sessions per week (in the last six months).

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (2)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

Universidade Federal do Rio Grande do Sul

Porto Alegre, 90035-003, Brazil

Location

Related Publications (1)

• Bock PM, Kowalewski LS, Ayres LR, Russo MKB, Leites GT, Martins AF, Oliveira AR, Krause M. Effect of heat therapy compared with strength training on metabolic profile, heat shock response, inflammation, cardiovascular responses and microbiota in individuals with type 2 diabetes: study protocol of a randomized trial. Sao Paulo Med J. 2025 Jun 2;143(3):e2024040. doi: 10.1590/1516-3180-2024.0040.R1.13082024. eCollection 2025.

  PMID: 40465937 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperthermia; Inflammation; Diabetes Mellitus

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Pathologic Processes

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Mauricio Krause, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Stahlhöfer Kowalewski, MSc

CONTACT

3535133082065; lucaskowalewski7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, the researcher conducting the exercise sessions as well as participants will not be blinded. To ensure assessor masking, the subjects are asked to omit their assigned group and not to talk about their interventions during the outcome evaluation sessions. In the case of unintentional unblinding for any reason, the involved researcher will notify the principal researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Volunteers who meet the inclusion criteria will be guided in the study and asked to sign a written informed consent before enrollment in the trial. Participants will be randomized into intervention groups Control (C), Resitance/Strength training (RT) or Heat Therapy (HT).

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 6, 2023
• Study Start: July 1, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)