High-intensity Interval Training Prescriptions to Reduce the Risk of Complications Linked to Type 2 Diabetes: the Role of Interval Length on Clinical Benefits and on Physiological Mechanisms

NCT04986345 | Unknown

• 1 other identifier: DT2-HIIT-Prot
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes (T2D) prevalence has steadily been rising in the past decades and its complications, including cardiovascular diseases (CVD), are a major public health concern. To lower CVD risk and to maintain an adequate glycemic control, Diabetes Canada recommends aerobic exercise of high-intensity interval training (HIIT). The leading hypothesis of this study is that longer intervals will favor an anti-inflammatory immune state, and that and that it will be correlated with reduced arterial stiffness and blood pressure.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes; Ambulatory blood pressure; Continous glucose monitoring; High-intensity interval training; Proteomics; Monocytes; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in ambulatory systolic and diastolic blood pressure

  mmHg, measured with an ambulatory blood pressure monitor

  During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)

Secondary Outcomes (19)

• Change in arterial stiffness

  30 min post-exercise (in lab measure) and during 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)

• Change in post-exercise glucose levels

  Every 5 min during 2 hours after each experimental condition (Rest, HIIT-4 and HIIT-10)

• Change in post-prandial glucose levels

  during the 2 hour-postprandial time (before and after standardized lunch, as well as at 7.5 , 15, 30 60, 90 and 120 min) for each experimental condition (Rest, HIIT-4, HIIT-10)

• Change in 24h glycemia

  During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)

• Change in nocturnal glycemia

  During the night, from 10 pm to 7 am following each the three experimental conditions (Rest, HIIT-4 and HIIT-10)

Study Arms (2)

Rest, HIIT-4, HIIT-10

EXPERIMENTAL

Both arms start with the rest condition and the order of the two other conditions (HIIT-4 and HIIT-10) is determined at random. This arm's sequence of intervention is : 1-Rest; 2- HIIT-4 and 3- HIIT-10.

Other: High-intensity interval training (HIIT)-4; Other: High-intensity interval training (HIIT)-10; Other: Rest

Rest, HIIT-10, HIIT-4

EXPERIMENTAL

Both arms start with the rest condition and the order of the two other conditions (HIIT-4 and HIIT-10) is determined at random. This arm's sequence of intervention is : 1- Rest; 2- HIIT-10 and 3- HIIT-4.

Other: High-intensity interval training (HIIT)-4; Other: High-intensity interval training (HIIT)-10; Other: Rest

Interventions

High-intensity interval training (HIIT)-4 OTHER

4 intervals of 4 minutes at 90% of maximum cardiac frequency, interspersed with 3-minute rests at 70% of maximum cardiac frequency. The session will last 32 minutes, including warm-up and cooldown.

Rest, HIIT-10, HIIT-4; Rest, HIIT-4, HIIT-10

High-intensity interval training (HIIT)-10 OTHER

10 intervals of 1 minutes at 90% of maximum cardiac frequency, interspersed with 1-minute rests at 70% of maximum cardiac frequency. The session will last 34 minutes, including warm-up and cooldown.

Rest, HIIT-10, HIIT-4; Rest, HIIT-4, HIIT-10

Rest OTHER

Participants are to stay seated for 30 minutes while reading or watching television.

Rest, HIIT-10, HIIT-4; Rest, HIIT-4, HIIT-10

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With a diagnostic for type 2 diabetes
• Arterial hypertension (controlled at rest)
• Low or no alcohol consumption (≤ 7 alcoholic beverages/week)
• Non-smoking
• Physically active ( \> 60 minutes of structured and scheduled physical activity/week for the previous 3 months)

You may not qualify if:

• Insulin therapy
• Use of beta blockers
• Unstable medication in the past 6 months
• Stroke in the past 6 months, or with consequences limiting physical activity practice
• Coronary disease without revascularization, or peripheral artery disease
• Neuropathy, retinopathy of nephropathy diagnostics
• Orthopedic limitations, or medical counter-indication for physical activity practice
• Surgery scheduled during the study period

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

Related Publications (13)

• Ormazabal V, Nair S, Elfeky O, Aguayo C, Salomon C, Zuniga FA. Association between insulin resistance and the development of cardiovascular disease. Cardiovasc Diabetol. 2018 Aug 31;17(1):122. doi: 10.1186/s12933-018-0762-4.

  PMID: 30170598 BACKGROUND

• Nalysnyk L, Hernandez-Medina M, Krishnarajah G. Glycaemic variability and complications in patients with diabetes mellitus: evidence from a systematic review of the literature. Diabetes Obes Metab. 2010 Apr;12(4):288-98. doi: 10.1111/j.1463-1326.2009.01160.x.

  PMID: 20380649 BACKGROUND

• Shalev V, Chodick G, Heymann AD, Kokia E. Gender differences in healthcare utilization and medical indicators among patients with diabetes. Public Health. 2005 Jan;119(1):45-9. doi: 10.1016/j.puhe.2004.03.004.

  PMID: 15560901 BACKGROUND

• Peters SA, Huxley RR, Sattar N, Woodward M. Sex Differences in the Excess Risk of Cardiovascular Diseases Associated with Type 2 Diabetes: Potential Explanations and Clinical Implications. Curr Cardiovasc Risk Rep. 2015;9(7):36. doi: 10.1007/s12170-015-0462-5.

  PMID: 26029318 BACKGROUND

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Sigal RJ, Armstrong MJ, Bacon SL, Boule NG, Dasgupta K, Kenny GP, Riddell MC. Physical Activity and Diabetes. Can J Diabetes. 2018 Apr;42 Suppl 1:S54-S63. doi: 10.1016/j.jcjd.2017.10.008. No abstract available.

  PMID: 29650112 BACKGROUND

• Amireault S, Baier JM, Spencer JR. Physical Activity Preferences Among Older Adults: A Systematic Review. J Aging Phys Act. 2018 Oct 25:1-12. doi: 10.1123/japa.2017-0234. Online ahead of print.

  PMID: 29283793 BACKGROUND

• Shanmugam N, Reddy MA, Guha M, Natarajan R. High glucose-induced expression of proinflammatory cytokine and chemokine genes in monocytic cells. Diabetes. 2003 May;52(5):1256-64. doi: 10.2337/diabetes.52.5.1256.

  PMID: 12716761 BACKGROUND

• Roy-Chowdhury E, Brauns N, Helmke A, Nordlohne J, Brasen JH, Schmitz J, Volkmann J, Fleig SV, Kusche-Vihrog K, Haller H, von Vietinghoff S. Human CD16+ monocytes promote a pro-atherosclerotic endothelial cell phenotype via CX3CR1-CX3CL1 interaction. Cardiovasc Res. 2021 May 25;117(6):1510-1522. doi: 10.1093/cvr/cvaa234.

  PMID: 32717023 BACKGROUND

• Lee JW, Cho E, Kim MG, Jo SK, Cho WY, Kim HK. Proinflammatory CD14(+)CD16(+) monocytes are associated with vascular stiffness in predialysis patients with chronic kidney disease. Kidney Res Clin Pract. 2013 Dec;32(4):147-52. doi: 10.1016/j.krcp.2013.08.001. Epub 2013 Sep 26.

  PMID: 26877933 BACKGROUND

• Ramirez-Jimenez M, Morales-Palomo F, Pallares JG, Mora-Rodriguez R, Ortega JF. Ambulatory blood pressure response to a bout of HIIT in metabolic syndrome patients. Eur J Appl Physiol. 2017 Jul;117(7):1403-1411. doi: 10.1007/s00421-017-3631-z. Epub 2017 May 10.

  PMID: 28493030 BACKGROUND

• Ito S. High-intensity interval training for health benefits and care of cardiac diseases - The key to an efficient exercise protocol. World J Cardiol. 2019 Jul 26;11(7):171-188. doi: 10.4330/wjc.v11.i7.171.

  PMID: 31565193 BACKGROUND

• Tremblay R, Marcotte-Chenard A, Deslauriers L, Boulay P, Boisvert FM, Geraldes P, Gayda M, Christou DD, Little JP, Mampuya W, Riesco E. Acute Effect of High-Intensity Interval Exercise on Blood Pressure in Females Living with Type 2 Diabetes and Hypertension. Med Sci Sports Exerc. 2025 May 1;57(5):951-961. doi: 10.1249/MSS.0000000000003639. Epub 2024 Dec 30.

  PMID: 39787496 DERIVED

• Low JL, Marcotte-Chenard A, Tremblay R, Islam H, Falkenhain K, Mampuya WM, Mari A, McManus AM, Riesco E, Little JP. An acute bout of 4 x 4-min or 10 x 1-min HIIT improves beta cell glucose sensitivity in postmenopausal females with type 2 diabetes: a secondary analysis. J Appl Physiol (1985). 2025 Jan 1;138(1):311-317. doi: 10.1152/japplphysiol.00777.2024. Epub 2024 Dec 18.

  PMID: 39694495 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Interventions

High-Intensity Interval Training; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Eléonor Riesco, PhD

CONTACT

1-819-821-8000; e.riesco@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A semi-randomized (experimental conditions) crossover design will be used with a population of elderly women with T2D, and with three experimental conditions (1- rest, 2-HIIT-10: 10x 1 min, 3- HIIT-4: 4 x 4 min).

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 2, 2021
• Study Start: October 4, 2021
• Primary Completion: May 15, 2023
• Study Completion: August 31, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)