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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593746
• Other study ID #: T2Dexercise.photobiomodulation
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: University of Nove de Julho
• Contact: Luciana MM Sampaio, Professor
• Phone: +551133859241
• Email: lucianamalosa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Brazil	UNINOVE	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Bassi D, Mendes RG, Arakelian VM, Caruso FC, Cabiddu R, Júnior 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. eCollection 2015 Jun. — View Citation

Boulé 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	Oxygen consumption measurement during cardiopulmonary test	Change from Baseline to 12 weeks
Primary	Incremental shuttle walking test	Distance in meters	Change from Baseline to 12 weeks
Primary	Glycemic control	Evaluated by the percentage of glycated hemoglobin	Change from Baseline to 12 weeks
Secondary	Autonomic Nervous System	Assesment by Heat Rate Variability analysis	Change from Baseline to 12 weeks
Secondary	Musculoskeletal Function	Muscular strength and endurance will be evaluated by Isokinetic Dynamometry	Change from Baseline to 12 weeks
Secondary	Physical Activity Questionnaire	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
Secondary	Endothelial Function	Endothelial function will be assessed by arterial flow-mediated dilation (FMD)	Change from Baseline to 12 weeks
Secondary	Quality of Life Questionary	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
Secondary	Body mass index (BMI)	Weight and height will be combined to report BMI (kg/m2)	Change from Baseline to 12 weeks
Secondary	Other Biochemical Analyzes	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