Diabetes Mellitus, Type 2 Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | August 31, 2023 |
Est. primary completion date | May 15, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche sur le vieillissement | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in arterial stiffness | Estimated using pulse wave velocity (m/s), measured with an ambulatory blood pressure monitor | 30 min post-exercise (in lab measure) and during 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in post-exercise glucose levels | Measured with a continuous glucose monitor (mmol/L) | Every 5 min during 2 hours after each experimental condition (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in post-prandial glucose levels | Measured with a continuous glucose monitor and blood samples (mmol/L) | 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) | |
Secondary | Change in 24h glycemia | Measured with a continuous glucose monitor (mmol/L) | During 24 hours after the three experimental conditions (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in nocturnal glycemia | Measured with a continuous glucose monitor (mmol/L) | During the night, from 10 pm to 7 am following each the three experimental conditions (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in time passed in hyperglycemia (> 10 mmol/L) | Measured with a continuous glucose monitor (minutes) | During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in time passed in hypoglycemia (< 3.8 mmol/L) | Measured with a continuous glucose monitor (minutes) | During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in time spent in range (between 3.8 and 10 mmol/L) | Measured with a continuous glucose monitor (minutes) | During 24 hours after each experimental conditions (Rest, HIIT-4 and HIIT-10) | |
Secondary | Change in the proteome of blood monocytes | Use of proteomics to identify and quantify proteins in isolated peripheral blood monocytes | Before, right after the end and 1hour post exercise (HIIT-4 and HIIT-10) | |
Secondary | Change in the proportions of blood monocytes subtypes | Surface expression of CD14 and CD16, assessed by flow cytometry on isolated monocytes. | Before, right after the end and 1hour post exercise (HIIT-4 and HIIT-10) | |
Secondary | Resting systolic and diastolic blood pressure | Measured with a manual sphygmomanometer | During the preliminary visit, after 5 min of rest in sitting position | |
Secondary | Total body weight | Measured with an electric scale (kg) | At baseline, in fasted state | |
Secondary | Height | Measured with an mural stadiometer (m) | At baseline, in fasted state | |
Secondary | 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. | Before and right after the end of exercise (HIIT-4 and HIIT-10) | |
Secondary | 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) | Before and right after the end of exercise conditions (HIIT-4 and HIIT-10) | |
Secondary | Change in plasma endothelial nitric oxide synthase (eNOS) | Enzyme-Linked Immunosorbent Assay (ELISA) to quantify the level of human eNOS in plasma (ng/mL). | Before, at the end of exercise and 1 hour post-exercise (HIIT-4 and HIIT-10) | |
Secondary | Change in plasma catecholamines | Enzyme-Linked Immunosorbent Assay (ELISA) to quantify the level of human epinephrine and norepinephrine in plasma (pg/mL). | Before, at the end of exercise and 1 hour post-exercise (HIIT-4 and HIIT-10) | |
Secondary | Change in plasma insulin | Dosage of plasma insulin (pmol/L) | 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) | |
Secondary | Change in plasma C-peptide | Dosage of plasma C-peptide (ng/mL) | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |