NCT06684912

Brief Summary

The endothelium is a protective lining of cells inside blood vessels. It keeps blood vessels working smoothly by controlling how wide or narrow your blood vessels are and protecting them from damage. Normally, the endothelium keeps a healthy balance between signals that relax or tighten blood vessels. But with advancing age or certain diseases like diabetes, this balance is disrupted. This can make blood vessels weaker and lead to serious problems in the heart and other organs. Researchers use a test called brachial flow-mediated dilation (FMD) to check how well blood vessels work. FMD shows how good blood vessels are at making a chemical called nitric oxide (NO), which helps them relax and widen. During the FMD test, researchers reduce blood flow for a short time with a blood pressure cuff, then release it to see how blood vessels respond. They use an ultrasound machine to measure this. While FMD is useful, it has some downsides-it's hard to do right, needs expensive tools, and experts don't always agree on how to analyze the results. A newer method called flow-mediated slowing (FMS) aims to fix these problems. FMS uses pulse wave velocity (PWV) to measure how stiff your blood vessels are. Stiffer vessels mean less nitric oxide and a higher chance of heart problems. After reducing blood flow with a blood pressure cuff and releasing it, healthy people show a drop in PWV (reduction in arterial stiffness), but people with heart failure or high blood pressure do not. Thus, FMS holds promise as it is an easier way to measure blood vessel health. Exercise training helps keep blood vessels healthy with advancing age. Research has shown that regular aerobic exercise, (running or biking), and strength exercise (lifting weights), can improve how blood vessels work and make them less stiff. This is true even for healthy people. For people with type 2 diabetes, exercise training is even more important to preserve blood vessel health. The intensity of exercise may determine how much blood vessels improve. Research has shown that high-intensity interval training (HIIT)-where you switch between hard exercise and rest-works better than steady, moderate exercise for making blood vessels healthier and less stiff. It is thought that HIIT improves blood vessel health partly by improving how the body uses insulin. Still, not all studies show that training improves blood vessel health in people with type 2 diabetes. A single session of exercise presents a challenge to blood vessels that allows researchers to understand how exercise over time improves blood vessel health. In addition, studying how blood vessels react to one workout (called the acute exercise model) is helpful because researchers can easily control things like the type of exercise, how hard it is, or how long it lasts. Acute exercise research also helps control other factors, such as nutrition, that may bias results. Thus, acute exercise research is a great method to learn how exercise works in the short term and how it might help in the long run. Therefore, the present study aimed to determine how FMD and FMS respond after an acute bout of high-intensity interval exercise and moderate continuous exercise in older adults without type 2 diabetes, and also healthy young adults. The key research questions were:

  1. 1.Is the FMD and FMS response after an acute bout of exercise dependent on exercise intensity?
  2. 2.Is the FMD and FMS response after an acute bout of exercise dependent on age and disease status?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 9, 2024

Last Update Submit

November 9, 2024

Conditions

Keywords

acute exerciseaerobic exercisehigh intensity aerobic exercisemoderate continuous aerobic training

Outcome Measures

Primary Outcomes (2)

  • Brachial endothelial function

    Brachial artery flow-mediated dilation - ultrasound

    Before and 10, and 60-minutes after acute aerobic exercise

  • Brachial artery stiffness

    Brachial artery flow-mediated slowing - ultrasound

    Before and 5, and 60-minutes after acute aerobic exercise

Secondary Outcomes (3)

  • Central arterial stiffness

    Before and 10, and 60-minutes after acute aerobic exercise

  • Upper limb arterial stiffness

    Before and 10, and 60-minutes after acute aerobic exercise

  • Lower limb arterial stiffness

    Before and 10, and 60-minutes after acute aerobic exercise

Study Arms (3)

CONTROL

NO INTERVENTION

A non-exercise condition.

High intensity interval exercise (HIIE)

EXPERIMENTAL

The HIIE was comprised of 1 min exercise bouts at 90% of oxygen uptake (V̇O2) reserve interspersed by 1 min active recovery bouts at 60% V̇O2 reserve (1:1).

Other: High-intensity interval exercise

Moderate-intensity exercise (MICE)

EXPERIMENTAL

MICE at 60% V̇O2 reserve with the duration adjusted to each participant so that each participant achieved the target energy expenditure.

Other: Moderate continuous exercise

Interventions

The number of bouts of exercise-recovery for each participant was tailored to achieve the desired EE. For example, a participant with a peak oxygen uptake (V̇O2) peak of 30 mL.kg-1.min-1, weighing 80 kg, would need 6 bouts to match the target EE, assuming 1L of O2 uptake equals 5 kcal.

High intensity interval exercise (HIIE)

Energy expenditure of exercise conditions (HIIE and MICE) were matched for energy expenditure. A participant with a V̇O2 peak of 30 mL.kg-1.min-1, weighing 80 kg, would need 6 bouts to match the target EE, assuming 1L of O2 uptake equals 5 kcal.

Also known as: MICE
Moderate-intensity exercise (MICE)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index \< 30 kg/m2
  • Less than two risk factors for cardiovascular disease (for participants without type diabetes mellitus)
  • No electrocardiographic or symptomatic abnormalities on the exercise stress
  • Physically active (3-5 days of structured exercise; for participants without type diabetes)
  • Glycosylated haemoglobin (HbA1c) levels (≥ 5.7% and bellow 8.0%) or fasting blood glucose ≥126 mg/dL and below 185 mg/dL) - for participants with type 2 diabetes

You may not qualify if:

  • Cardiovascular disease (e.g., heart failure, ischemic heart disease)
  • Orthostatic intolerance
  • Thyroid dysfunction
  • Mental disease
  • Microvascular complications (e.g., neuropathies)
  • Renal disease
  • Musculoskeletal disease (e.g., sarcopenia, osteoporosis)
  • Smoking
  • Vasoactive medications (e.g. angiotensin-converting enzyme inhibitors, calcium channel blockers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Motricidade Humana - University of Lisbon

Lisbon, Portugal

Location

Related Publications (9)

  • Francois ME, Little JP. The impact of acute high-intensity interval exercise on biomarkers of cardiovascular health in type 2 diabetes. Eur J Appl Physiol. 2017 Aug;117(8):1607-1616. doi: 10.1007/s00421-017-3649-2. Epub 2017 May 31.

    PMID: 28567668BACKGROUND
  • Magalhaes JP, Melo X, Correia IR, Ribeiro RT, Raposo J, Dores H, Bicho M, Sardinha LB. Effects of combined training with different intensities on vascular health in patients with type 2 diabetes: a 1-year randomized controlled trial. Cardiovasc Diabetol. 2019 Mar 18;18(1):34. doi: 10.1186/s12933-019-0840-2.

    PMID: 30885194BACKGROUND
  • Colberg SR, Albright AL, Blissmer BJ, Braun B, Chasan-Taber L, Fernhall B, Regensteiner JG, Rubin RR, Sigal RJ; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: American College of Sports Medicine and the American Diabetes Association: joint position statement. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2010 Dec;42(12):2282-303. doi: 10.1249/MSS.0b013e3181eeb61c.

    PMID: 21084931BACKGROUND
  • Fiuza-Luces C, Santos-Lozano A, Joyner M, Carrera-Bastos P, Picazo O, Zugaza JL, Izquierdo M, Ruilope LM, Lucia A. Exercise benefits in cardiovascular disease: beyond attenuation of traditional risk factors. Nat Rev Cardiol. 2018 Dec;15(12):731-743. doi: 10.1038/s41569-018-0065-1.

    PMID: 30115967BACKGROUND
  • Ashor AW, Lara J, Siervo M, Celis-Morales C, Oggioni C, Jakovljevic DG, Mathers JC. Exercise modalities and endothelial function: a systematic review and dose-response meta-analysis of randomized controlled trials. Sports Med. 2015 Feb;45(2):279-96. doi: 10.1007/s40279-014-0272-9.

    PMID: 25281334BACKGROUND
  • Ellins EA, New KJ, Datta DB, Watkins S, Haralambos K, Rees A, Aled Rees D, Halcox JP. Validation of a new method for non-invasive assessment of vasomotor function. Eur J Prev Cardiol. 2016 Apr;23(6):577-83. doi: 10.1177/2047487315597210. Epub 2015 Jul 24.

    PMID: 26209709BACKGROUND
  • Naka KK, Tweddel AC, Doshi SN, Goodfellow J, Henderson AH. Flow-mediated changes in pulse wave velocity: a new clinical measure of endothelial function. Eur Heart J. 2006 Feb;27(3):302-9. doi: 10.1093/eurheartj/ehi619. Epub 2005 Nov 2.

    PMID: 16267075BACKGROUND
  • Thijssen DHJ, Bruno RM, van Mil ACCM, Holder SM, Faita F, Greyling A, Zock PL, Taddei S, Deanfield JE, Luscher T, Green DJ, Ghiadoni L. Expert consensus and evidence-based recommendations for the assessment of flow-mediated dilation in humans. Eur Heart J. 2019 Aug 7;40(30):2534-2547. doi: 10.1093/eurheartj/ehz350.

    PMID: 31211361BACKGROUND
  • Cahill PA, Redmond EM. Vascular endothelium - Gatekeeper of vessel health. Atherosclerosis. 2016 May;248:97-109. doi: 10.1016/j.atherosclerosis.2016.03.007. Epub 2016 Mar 9.

    PMID: 26994427BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Xavier Melo, PhD

    Egas Moniz School of Health & Science

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2024

First Posted

November 12, 2024

Study Start

January 5, 2020

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Data obtained in this study may be provided to qualified researchers with an academic interest in vascular responses to exercise in people with type 2 diabetes. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Shared Documents
STUDY PROTOCOL
Time Frame
Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Locations