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

NCT ID: NCT03593746

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-12-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2; High-Intensity Interval Training; Exercise Training; Hyperglycaemia Due to Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HIIT and LED therapy

Light-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT)

Group Type: EXPERIMENTAL

Physical training

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).

Light-Emitting Diode (LED) therapy

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

High intensity interval training (HIIT)

Light-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT)

Group Type: SHAM_COMPARATOR

Physical training

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).

Light-Emitting Diode (LED) therapy

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

Combined training and LED therapy

Light-Emitting Diode (LED) therapy followed by physical training with combined training

Group Type: EXPERIMENTAL

Physical training

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).

Light-Emitting Diode (LED) therapy

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

Combined training

Light-Emitting Diode (LED) therapy simulation followed by physical training with combined training.

Group Type: SHAM_COMPARATOR

Physical training

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).

Light-Emitting Diode (LED) therapy

Intervention Type: OTHER

Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

Interventions

Physical training

Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).

Intervention Type: OTHER

Light-Emitting Diode (LED) therapy

Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

LUCIANA MARIA MALOSA SAMPAIO

Professor of the postgraduate program in Rehabilitation Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana MM Sampaio, Professor

Role: PRINCIPAL_INVESTIGATOR

Nove de Julho University

Locations

UNINOVE

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Luciana MM Sampaio, Professor

Role: CONTACT

lucianamalosa@gmail.com

+551133859241

Cauê Padovani, Phd

Role: CONTACT

cauepadovani@hotmail.com

+55969288228

Facility Contacts

Luciana Sampaio, PhD

Role: primary

References

Bassi D, Mendes RG, Arakelian VM, Caruso FC, Cabiddu R, Junior JC, Arena R, Borghi-Silva A. Potential Effects on Cardiorespiratory and Metabolic Status After a Concurrent Strength and Endurance Training Program in Diabetes Patients - a Randomized Controlled Trial. Sports Med Open. 2016 Aug 11;2:31. doi: 10.1186/s40798-016-0052-1. eCollection 2015 Jun.

Reference Type: BACKGROUND

PMID: 27563535 (View on PubMed)

Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.

Reference Type: BACKGROUND

PMID: 11559268 (View on PubMed)

Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.

Reference Type: BACKGROUND

PMID: 23002086 (View on PubMed)

Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ. Effect of lifestyle intervention in patients with type 2 diabetes: a meta-analysis. Metabolism. 2015 Feb;64(2):338-47. doi: 10.1016/j.metabol.2014.10.018. Epub 2014 Oct 23.

Reference Type: BACKGROUND

PMID: 25467842 (View on PubMed)

Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.

Reference Type: BACKGROUND

PMID: 26258597 (View on PubMed)

Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.

Reference Type: BACKGROUND

PMID: 25717277 (View on PubMed)

Madsen SM, Thorup AC, Overgaard K, Bjerre M, Jeppesen PB. Functional and structural vascular adaptations following 8 weeks of low volume high intensity interval training in lower leg of type 2 diabetes patients and individuals at high risk of metabolic syndrome. Arch Physiol Biochem. 2015;121(5):178-86. doi: 10.3109/13813455.2015.1087033. Epub 2015 Oct 15.

Reference Type: BACKGROUND

PMID: 26471849 (View on PubMed)

Gibbs BB, Dobrosielski DA, Lima M, Bonekamp S, Stewart KJ, Clark JM. The association of arterial shear and flow-mediated dilation in diabetes. Vasc Med. 2011 Aug;16(4):267-74. doi: 10.1177/1358863X11411361. Epub 2011 Jun 27.

Reference Type: BACKGROUND

PMID: 21708874 (View on PubMed)

Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.

Reference Type: BACKGROUND

PMID: 21115771 (View on PubMed)

Other Identifiers

T2Dexercise.photobiomodulation

Identifier Type: -

Identifier Source: org_study_id