Diabetes Mellitus, Type 2NCT04986345
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
A study testing High-intensity interval training (HIIT)-4, High-intensity interval training (HIIT)-10 and Rest in people with Diabetes Mellitus, Type 2, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- High-intensity interval training (HIIT)-4, High-intensity interval training (HIIT)-10 and Rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
Eléonor Riesco, PhD, 1-819-821-8000 ext. 63337, eleonore.riesco@usherbrooke.ca
Eléonor Riesco, PhD
About this study
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.
Read the detailed description
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. Insulin resistance, an important component of T2D, is associated with vascular dysfunctions, which directly contributes to the pathogenesis of CVD, such as atherosclerosis, and hypertension, particularly with the elderly. It is also suggested that glucose variability, measured with continuous glucose monitors (CGM), is an independent risk factor of CVD in T2D individuals, exposing them to an increased risk of premature death. Moreover, in part because of immune dysregulation, women with T2D are at a heightened risk of developing CVD compared to males. Indeed, monocyte inflammatory profile is altered during the aging process and in women with T2D. This, in turn, causes vascular dysfunction which is associated with a pro-thrombotic state, and exacerbates atherosclerosis and arterial stiffening.
To lower CVD risk and to maintain an adequate glycemic control, Diabetes Canada recommends aerobic exercise of high-intensity interval training (HIIT). However, this recommendation is solely based on the improvement of cardiorespiratory fitness in type 2 diabetes individuals (level of evidence: grade B, level 2). Furthermore, most of these studies use exercise protocols with ergocycles, which limit the ecological validity considering that the elderly population prefers to walk. Though, it is essential to evaluate the impact of different walking HIIT protocols on clinical targets such as arterial pressure, glycemic variability/control using ambulatory blood pressure monitors (ABPM) and CGM.
The preliminary data collected in our laboratory shows that a low volume HIIIT program (6 × 1 min) is insufficient to improve glycemic control/variability and ambulatory blood pressure over 24 hours in elderly diabetic women, despite reducing inflammatory gene expression in monocytes. Interestingly, pro-inflammatory monocytes are linked with hyperglycemia and play a crucial role in the atherosclerotic process, while also being associated with arterial stiffening in individuals with kidney failure, a common T2D complication.
These results raise several questions, including the role played by the length of HIIT intervals on clinical targets. While our preliminary results didn't impact ambulatory blood pressure over 24 hours with shorter intervals (6 × 1 min), other studied showed a reduction of this parameter with longer intervals (4 x 4 min). Therefore, the leading hypothesis of this study is that longer high intensity intervals (Wisløff protocol: 4 x 4 min) will reduce ambulatory blood pressure over 24 hours in a greater extent than shorter intervals (10 x 1 min). Indeed, reduced shear stress induced by shorter intervals could damper cellular and molecular responses to exercise bouts, thereby limiting the effects on arterial stiffness and blood pressure in the hours following exercise. Moreover, changes in gene expression do not guarantee changes at the protein level, and proteins are the real effectors of cellular response. Hence, proteomics will be useful to better understand monocyte response to different HIIT protocols and, possibly, the clinical benefits of this training method. Indeed, longer intervals could induce greater variations to the monocytes' proteome, favoring an anti-inflammatory phenotype, and those changes could be associated with reduced arterial stiffness and blood pressure.
The primary objective of this study is therefore to compare the effect of two treadmill HIIT modalities (4x4 min vs. 10x1 min) on arterial stiffness, ambulatory blood pressure over 24 hours and on glycemic variability in elderly women with T2D. The secondary objective is to assess the proteomic changes in monocytes induced by the two HIIT modalities and to correlate them with changes in clinical parameters.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- High-intensity interval training (HIIT)-4, High-intensity interval training (HIIT)-10, Rest
- Keywords
- Type 2 diabetes, Ambulatory blood pressure, Continous glucose monitoring, High-intensity interval training, Proteomics, Monocytes, Inflammation
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIIT)-4Other
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.
High-intensity interval training (HIIT)-10Other
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.
RestOther
Participants are to stay seated for 30 minutes while reading or watching television.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High-intensity interval training (HIIT)-4; Other: High-intensity interval training (HIIT)-10; Other: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ambulatory systolic and diastolic blood pressure
mmHg, measured with an ambulatory blood pressure monitor
Measured: During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)
Secondary outcomes (19)
Change in arterial stiffness
Estimated using pulse wave velocity (m/s), measured with an ambulatory blood pressure monitor
Measured: 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
Measured with a continuous glucose monitor (mmol/L)
Measured: Every 5 min during 2 hours after each experimental condition (Rest, HIIT-4 and HIIT-10)
Change in post-prandial glucose levels
Measured with a continuous glucose monitor and blood samples (mmol/L)
Measured: 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
Measured with a continuous glucose monitor (mmol/L)
Measured: During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in nocturnal glycemia
Measured with a continuous glucose monitor (mmol/L)
Measured: During the night, from 10 pm to 7 am following each the three experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in time passed in hyperglycemia (> 10 mmol/L)
Measured with a continuous glucose monitor (minutes)
Measured: During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in time passed in hypoglycemia (< 3.8 mmol/L)
Measured with a continuous glucose monitor (minutes)
Measured: During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in time spent in range (between 3.8 and 10 mmol/L)
Measured with a continuous glucose monitor (minutes)
Measured: During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in the proteome of blood monocytes
Use of proteomics to identify and quantify proteins in isolated peripheral blood monocytes
Measured: Before, right after the end and 1hour post exercise (HIIT-4 and HIIT-10)
Change in the proportions of blood monocytes subtypes
Surface expression of CD14 and CD16, assessed by flow cytometry on isolated monocytes.
Measured: Before, right after the end and 1hour post exercise (HIIT-4 and HIIT-10)
Resting systolic and diastolic blood pressure
Measured with a manual sphygmomanometer
Measured: During the preliminary visit, after 5 min of rest in sitting position
Total body weight
Measured with an electric scale (kg)
Measured: At baseline, in fasted state
Height
Measured with an mural stadiometer (m)
Measured: At baseline, in fasted state
Change in monocyte-derived macrophages polarization
Surface expression of CD86 and CD206, assessed by flow cytometry on monocyte-derived macrophages differentiated 5 days in vitro.
Measured: Before and right after the end of exercise (HIIT-4 and HIIT-10)
Change in monocyte-derived macrophages response to lipopolysaccharide (LPS)
Monocyte-derived macrophages differentiated 5 days in vitro will be treated or not with LPS for 24h. Culture media will be collected for cytokine secretion determination (Multiplex Luminex)
Measured: Before and right after the end of exercise conditions (HIIT-4 and HIIT-10)
Change in plasma endothelial nitric oxide synthase (eNOS)
Enzyme-Linked Immunosorbent Assay (ELISA) to quantify the level of human eNOS in plasma (ng/mL).
Measured: Before, at the end of exercise and 1 hour post-exercise (HIIT-4 and HIIT-10)
Change in plasma catecholamines
Enzyme-Linked Immunosorbent Assay (ELISA) to quantify the level of human epinephrine and norepinephrine in plasma (pg/mL).
Measured: Before, at the end of exercise and 1 hour post-exercise (HIIT-4 and HIIT-10)
Change in plasma insulin
Dosage of plasma insulin (pmol/L)
Measured: 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 plasma C-peptide
Dosage of plasma C-peptide (ng/mL)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start4 Oct 2021
- Primary completion15 May 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986345
- Sponsor's protocol ID
- DT2-HIIT-Prot
- Status last verified
- Mar 2023
- First submitted
- 7 Jul 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30170598Nalysnyk 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.
PubMed 20380649Shalev 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.
PubMed 15560901Peters 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.
PubMed 26029318Diabetes 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.
PubMed 29650112Amireault 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.
PubMed 29283793Shanmugam 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.
PubMed 12716761Roy-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.
PubMed 32717023Lee 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.
PubMed 26877933Ramirez-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.
PubMed 28493030Ito 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.
PubMed 31565193Tremblay 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.
PubMed 39787496Low 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.
PubMed 39694495
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04986345
- Acronym / sponsor ID
- DT2-HIIT-Prot
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, Ambulatory blood pressure, Continous glucose monitoring, High-intensity interval training, Proteomics, Monocytes, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Insulin resistance, an important component of T2D, is associated with vascular dysfunctions, which directly contributes to the pathogenesis of CVD, such as atherosclerosis, and hypertension, particularly with the elderly. It is also suggested that glucose variability, measured with continuous glucose monitors (CGM), is an independent risk factor of CVD in T2D individuals, exposing them to an increased risk of premature death. Moreover, in part because of immune dysregulation, women with T2D are at a heightened risk of developing CVD compared to males. Indeed, monocyte inflammatory profile is altered during the aging process and in women with T2D. This, in turn, causes vascular dysfunction which is associated with a pro-thrombotic state, and exacerbates atherosclerosis and arterial stiffening.
To lower CVD risk and to maintain an adequate glycemic control, Diabetes Canada recommends aerobic exercise of high-intensity interval training (HIIT). However, this recommendation is solely based on the improvement of cardiorespiratory fitness in type 2 diabetes individuals (level of evidence: grade B, level 2). Furthermore, most of these studies use exercise protocols with ergocycles, which limit the ecological validity considering that the elderly population prefers to walk. Though, it is essential to evaluate the impact of different walking HIIT protocols on clinical targets such as arterial pressure, glycemic variability/control using ambulatory blood pressure monitors (ABPM) and CGM.
The preliminary data collected in our laboratory shows that a low volume HIIIT program (6 × 1 min) is insufficient to improve glycemic control/variability and ambulatory blood pressure over 24 hours in elderly diabetic women, despite reducing inflammatory gene expression in monocytes. Interestingly, pro-inflammatory monocytes are linked with hyperglycemia and play a crucial role in the atherosclerotic process, while also being associated with arterial stiffening in individuals with kidney failure, a common T2D complication.
These results raise several questions, including the role played by the length of HIIT intervals on clinical targets. While our preliminary results didn't impact ambulatory blood pressure over 24 hours with shorter intervals (6 × 1 min), other studied showed a reduction of this parameter with longer intervals (4 x 4 min). Therefore, the leading hypothesis of this study is that longer high intensity intervals (Wisløff protocol: 4 x 4 min) will reduce ambulatory blood pressure over 24 hours in a greater extent than shorter intervals (10 x 1 min). Indeed, reduced shear stress induced by shorter intervals could damper cellular and molecular responses to exercise bouts, thereby limiting the effects on arterial stiffness and blood pressure in the hours following exercise. Moreover, changes in gene expression do not guarantee changes at the protein level, and proteins are the real effectors of cellular response. Hence, proteomics will be useful to better understand monocyte response to different HIIT protocols and, possibly, the clinical benefits of this training method. Indeed, longer intervals could induce greater variations to the monocytes' proteome, favoring an anti-inflammatory phenotype, and those changes could be associated with reduced arterial stiffness and blood pressure.
The primary objective of this study is therefore to compare the effect of two treadmill HIIT modalities (4x4 min vs. 10x1 min) on arterial stiffness, ambulatory blood pressure over 24 hours and on glycemic variability in elderly women with T2D. The secondary objective is to assess the proteomic changes in monocytes induced by the two HIIT modalities and to correlate them with changes in clinical parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Rest, HIIT-4, HIIT-10 | Experimental | Other: High-intensity interval training (HIIT)-4, Other: High-intensity interval training (HIIT)-10, Other: RestBoth 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. |
| Rest, HIIT-10, HIIT-4 | Experimental | Other: High-intensity interval training (HIIT)-4, Other: High-intensity interval training (HIIT)-10, Other: RestBoth 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training (HIIT)-44 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. | Other | Rest, HIIT-10, HIIT-4, Rest, HIIT-4, HIIT-10 |
| High-intensity interval training (HIIT)-1010 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. | Other | Rest, HIIT-10, HIIT-4, Rest, HIIT-4, HIIT-10 |
| RestParticipants are to stay seated for 30 minutes while reading or watching television. | Other | Rest, HIIT-10, HIIT-4, Rest, HIIT-4, HIIT-10 |
Primary outcome
Change in ambulatory systolic and diastolic blood pressure
Time frame: During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)
mmHg, measured with an ambulatory blood pressure monitor
19 secondary outcomes
Change in arterial stiffness
Time frame: 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
Time frame: Every 5 min during 2 hours after each experimental condition (Rest, HIIT-4 and HIIT-10)
Change in post-prandial glucose levels
Time frame: 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
Time frame: During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in nocturnal glycemia
Time frame: During the night, from 10 pm to 7 am following each the three experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in time passed in hyperglycemia (> 10 mmol/L)
Time frame: During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in time passed in hypoglycemia (< 3.8 mmol/L)
Time frame: During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in time spent in range (between 3.8 and 10 mmol/L)
Time frame: During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10)
Change in the proteome of blood monocytes
Time frame: Before, right after the end and 1hour post exercise (HIIT-4 and HIIT-10)
Change in the proportions of blood monocytes subtypes
Time frame: Before, right after the end and 1hour post exercise (HIIT-4 and HIIT-10)
Resting systolic and diastolic blood pressure
Time frame: During the preliminary visit, after 5 min of rest in sitting position
Total body weight
Time frame: At baseline, in fasted state
Height
Time frame: At baseline, in fasted state
Change in monocyte-derived macrophages polarization
Time frame: Before and right after the end of exercise (HIIT-4 and HIIT-10)
Change in monocyte-derived macrophages response to lipopolysaccharide (LPS)
Time frame: Before and right after the end of exercise conditions (HIIT-4 and HIIT-10)
Change in plasma endothelial nitric oxide synthase (eNOS)
Time frame: Before, at the end of exercise and 1 hour post-exercise (HIIT-4 and HIIT-10)
Change in plasma catecholamines
Time frame: Before, at the end of exercise and 1 hour post-exercise (HIIT-4 and HIIT-10)
Change in plasma insulin
Time frame: 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 plasma C-peptide
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 30170598Ormazabal 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.
- Background: PubMed 20380649Nalysnyk 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.
- Background: PubMed 15560901Shalev 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.
- Background: PubMed 26029318Peters 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.
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- Background: PubMed 32717023Roy-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.
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- Derived from this study: PubMed 39787496Tremblay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIIT)-4, High-intensity interval training (HIIT)-10 and Rest in people with Diabetes Mellitus, Type 2, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eléonor Riesco, PhD (1-819-821-8000 ext. 63337, e.riesco@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ambulatory systolic and diastolic blood pressure (time frame: During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986345, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.