Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients

May 16, 2022 updated by: LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho

Effects of High Intensity Interval Training and Combined Training Associated With Photobiomodulation in Type 2 Diabetic (T2D) Patients: a Randomized Controlled Clinical Trial

Diabetes has become a widespread epidemic, primarily because of the increasing prevalence and incidence of type 2 diabetes (T2D). T2D is a significant cause of premature mortality and morbidity related to cardiovascular disease, blindness, kidney and nerve disease, and amputation.

Physical activity improves blood glucose control and can prevent or delay T2D, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life. At present, although physical activity is a key element in the prevention and management of T2D, the most effective exercise strategy (intensity, duration, and type of exercise) for improving glucose control and reducing cardiometabolic risk in type 2 diabetes has not been defined.

Studies with Light-Emitting Diode (LED) therapy have demonstrated its ability to promote pain relief, improve muscle and cardiopulmonary performance, minimize muscle fatigue, and stimulate wound healing. In relation to patients with T2D, who have prolonged conditions of hyperglycemia, studies to investigate the impact of photobiomodulation associated with physical training have not been found so far.

The objective of this study is to investigate the effects of different types of physical training associated with Light-Emitting Diode (LED) therapy on cardiometabolic status and quality of life in patients with T2D.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes (T2D) is a significant health problem worldwide due to its high prevalence and mortality. It is chronic metabolic disorder characterized by hyperglycemia resulting from a relative deficiency in insulin through either reduced insulin secretion or reduced insulin action or both. The subsequent chronic hyperglycaemia causes glycation of tissues, which almost inevitably leads to acute disturbances in metabolism and long term end organ damage, especially the blood vessels, heart, and nerves, and severe health complications.

Individuals with T2D have reduced aerobic fitness characterized by lower peak pulmonary oxygen uptake. Many potential mechanisms could explain this impaired response, for example, reduced muscle blood flow and capillary density, defects in muscular oxygen diffusion, and lower mitochondrial oxygen utilization and function.

T2D is also associated with lower baroreflex sensitivity and abnormal chronotropic response, altering heart rate regulation. In addition, prolonged hyperglycemia in T2D causes a number of pathological changes in vascular endothelial cells, increasing the production of reactive oxygen species and inflammatory cytokines that cause mitochondrial dysfunction and oxidative damage.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 03332010
        • Recruiting
        • UniNove
        • Contact:
          • Luciana Sampaio, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Confirmed diagnosis of type 2 diabetes;
  • Sedentary lifestyle in the last six months, according to the criteria established by the American Heart Association (AHA).

Exclusion Criteria:

  • Confirmed diagnosis of any (1) heart disease; (2) musculoskeletal disorder; (3) respiratory disease; (4) uncontrolled arterial hypertension; (5) peripheral neuropathy or (6) factors that limit the performance of any of the study evaluations and/or training.
  • During the study, individuals with a presence of less than 80% in the training sessions will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HIIT and LED therapy
Light-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT)
Other: Physical training
Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
Other: Light-Emitting Diode (LED) therapy
Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).
SHAM_COMPARATOR: High intensity interval training (HIIT)
Light-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT)
Other: Physical training
Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
Other: Light-Emitting Diode (LED) therapy
Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).
EXPERIMENTAL: Combined training and LED therapy
Light-Emitting Diode (LED) therapy followed by physical training with combined training
Other: Physical training
Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
Other: Light-Emitting Diode (LED) therapy
Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).
SHAM_COMPARATOR: Combined training
Light-Emitting Diode (LED) therapy simulation followed by physical training with combined training.
Other: Physical training
Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
Other: Light-Emitting Diode (LED) therapy
Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional exercise capacity
Time Frame: Change from Baseline to 12 weeks
Oxygen consumption measurement during cardiopulmonary test
Change from Baseline to 12 weeks
Incremental shuttle walking test
Time Frame: Change from Baseline to 12 weeks
Distance in meters
Change from Baseline to 12 weeks
Glycemic control
Time Frame: Change from Baseline to 12 weeks
Evaluated by the percentage of glycated hemoglobin
Change from Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Nervous System
Time Frame: Change from Baseline to 12 weeks
Assesment by Heat Rate Variability analysis
Change from Baseline to 12 weeks
Musculoskeletal Function
Time Frame: Change from Baseline to 12 weeks
Muscular strength and endurance will be evaluated by Isokinetic Dynamometry
Change from Baseline to 12 weeks
Physical Activity Questionnaire
Time Frame: Change from Baseline to 12 weeks
The level of physical activity will be assessed using the international questionnaire short version physical activity (IPAQ). The continuous score allows assessing energy expenditure expressed in MET minutes/week. The IPAQ categories include: Insufficiently active (does not perform any physical activity); Sufficiently active (conducts vigorous activity at least three days a week >600 MET - 1400 MET); Very active (performs more than three days per week of vigorous activity 1500 MET - 3000 MET).
Change from Baseline to 12 weeks
Endothelial Function
Time Frame: Change from Baseline to 12 weeks
Endothelial function will be assessed by arterial flow-mediated dilation (FMD)
Change from Baseline to 12 weeks
Quality of Life Questionary
Time Frame: Change from Baseline to 12 weeks
Assesment by using the questionnaire Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36). The SF-36 has eight sections (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning and Mental health). The scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability and higher scores = less disability.
Change from Baseline to 12 weeks
Body mass index (BMI)
Time Frame: Change from Baseline to 12 weeks
Weight and height will be combined to report BMI (kg/m2)
Change from Baseline to 12 weeks
Other Biochemical Analyzes
Time Frame: Change from Baseline to 12 weeks
Total cholesterol (Total-C) (mg/dl), low-density lipoprotein cholesterol (LDL-C) (mg/dl), high-density lipoprotein cholesterol (HDL-C) (mg/dl) and triglycerides (mg/dl)
Change from Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Investigators

  • Principal Investigator: Luciana MM Sampaio, Professor, Nove de Julho University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (ACTUAL)

July 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2Dexercise.photobiomodulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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