Diabetes Mellitus, Type 2ARM WRESTLINGNCT06684912
Acute Effects of Aerobic Exercise on Flow Mediated Slowing and Flow Mediated Dilation in Adults With and Without Type 2 Diabetes
A study testing High-intensity interval exercise and Moderate continuous exercise in people with Diabetes Mellitus, Type 2, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- High-intensity interval exercise and Moderate continuous exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2020to 15 Jan 2022
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiovascular disease (e.g., heart failure, ischemic heart disease)
- Orthostatic intolerance
- Thyroid dysfunction
- Mental disease
- Microvascular complications (e.g., neuropathies)
- Renal disease
Show all 9Show fewer
- Musculoskeletal disease (e.g., sarcopenia, osteoporosis)
- Smoking
- Vasoactive medications (e.g. angiotensin-converting enzyme inhibitors, calcium channel blockers)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Moderate Intensity Continuous Exercise Versus High-Intensity Interval Exercise on Flow Mediated Slowing and Flow Mediated Dilation in Adults With and Without Type 2 Diabetes
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.
Read more
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:
- Is the FMD and FMS response after an acute bout of exercise dependent on exercise intensity?
- Is the FMD and FMS response after an acute bout of exercise dependent on age and disease status?
All participants were asked to:
Complete two exercise sessions - one moderate- and one high-intensity interval bout on a treadmill. The order of the sessions was randomly assigned, similar to flipping a coin.
FMD and FMS were measured before and after each acute exercise bout in the laboratory.
The researchers compared FMD and FMS responses between exercise intensities (high vs. moderate) and populations (individuals with and without type diabetes).
Read the detailed description
The study was designed as a randomized, cross-over, repeated-measures experiment. Participants attended 3 separate intervention sessions consisting of an acute bout of HIIE, an acute bout of MICE, or a no exercise (CON) condition, in randomized order (http://www.randomizer.org/) to which participants were blinded until arrival at the laboratory. On a separate day before the interventions, all participants performed a cardiopulmonary exercise test (CPET). The exercise sessions began and ended with a warm-up and a cool-down, respectively, with a duration of 3 min each at 60% of V̇O2 reserve. Both the HIIE and MICE protocols were designed to match a weekly energy expenditure (EE) of 8 kcal.kg-1 week-1 comprising 3 hypothetical exercise sessions per week. Both protocols were individually tailored to each participant regarding his weight and peak oxygen uptake (V̇O2 peak), and the prescribed target intensities were supervised by an exercise physiologist with a heart rate monitor (Garmin, US) throughout the session. To eliminate the possible diurnal variation, each participant performed all interventions at an equal time of day (in the mornings) with a minimum of 48h between sessions. Post-exercise measurements at 10 and 60 min were aimed to characterize the post-exercise biphasic response of the brachial endothelial function. Participants reported to the laboratory in a fasting state (≥ 4h) and refrained from vigorous exercise, vitamin supplements, foods/drinks containing caffeine, and alcohol for at least 24h before each session.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- High-intensity interval exercise, Moderate continuous exercise
- Keywords
- acute exercise, aerobic exercise, high intensity aerobic exercise, moderate continuous aerobic training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval exerciseOther
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.
Moderate continuous exerciseOther
Also called MICE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Moderate continuous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial endothelial function
Brachial artery flow-mediated dilation - ultrasound
Measured: Before and 10, and 60-minutes after acute aerobic exercise
Brachial artery stiffness
Brachial artery flow-mediated slowing - ultrasound
Measured: Before and 5, and 60-minutes after acute aerobic exercise
Secondary outcomes (3)
Central arterial stiffness
Applanation tonometry - carotid-femoral pulse wave velocity
Measured: Before and 10, and 60-minutes after acute aerobic exercise
Upper limb arterial stiffness
Applanation tonometry - carotid-radial pulse wave velocity
Measured: Before and 10, and 60-minutes after acute aerobic exercise
Lower limb arterial stiffness
Applanation tonometry - carotid-dorsalis pedis pulse wave velocity
Measured: Before and 10, and 60-minutes after acute aerobic exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start5 Jan 2020
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Motricidade Humana
- Responsible party
- Sponsor
- Investigators
- Xavier Melo, PhD, Principal investigator, Egas Moniz School of Health & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684912
- Sponsor's protocol ID
- ARM WRESTLING
- Acronym
- ARM WRESTLING
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28567668Magalhaes 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.
PubMed 30885194Colberg 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.
PubMed 21084931Fiuza-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.
PubMed 30115967Ashor 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.
PubMed 25281334Ellins 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.
PubMed 26209709Naka 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.
PubMed 16267075Thijssen 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.
PubMed 31211361Cahill 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.
PubMed 26994427
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Moderate Intensity Continuous Exercise Versus High-Intensity Interval Exercise on Flow Mediated Slowing and Flow Mediated Dilation in Adults With and Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06684912
- Acronym / sponsor ID
- ARM WRESTLING / ARM WRESTLING
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- acute exercise, aerobic exercise, high intensity aerobic exercise, moderate continuous aerobic training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- Faculdade de Motricidade Humana
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 12 Nov 2024 (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.
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:
- Is the FMD and FMS response after an acute bout of exercise dependent on exercise intensity?
- Is the FMD and FMS response after an acute bout of exercise dependent on age and disease status?
All participants were asked to:
Complete two exercise sessions - one moderate- and one high-intensity interval bout on a treadmill. The order of the sessions was randomly assigned, similar to flipping a coin.
FMD and FMS were measured before and after each acute exercise bout in the laboratory.
The researchers compared FMD and FMS responses between exercise intensities (high vs. moderate) and populations (individuals with and without type diabetes).
Detailed description
The study was designed as a randomized, cross-over, repeated-measures experiment. Participants attended 3 separate intervention sessions consisting of an acute bout of HIIE, an acute bout of MICE, or a no exercise (CON) condition, in randomized order (http://www.randomizer.org/) to which participants were blinded until arrival at the laboratory. On a separate day before the interventions, all participants performed a cardiopulmonary exercise test (CPET). The exercise sessions began and ended with a warm-up and a cool-down, respectively, with a duration of 3 min each at 60% of V̇O2 reserve. Both the HIIE and MICE protocols were designed to match a weekly energy expenditure (EE) of 8 kcal.kg-1 week-1 comprising 3 hypothetical exercise sessions per week. Both protocols were individually tailored to each participant regarding his weight and peak oxygen uptake (V̇O2 peak), and the prescribed target intensities were supervised by an exercise physiologist with a heart rate monitor (Garmin, US) throughout the session. To eliminate the possible diurnal variation, each participant performed all interventions at an equal time of day (in the mornings) with a minimum of 48h between sessions. Post-exercise measurements at 10 and 60 min were aimed to characterize the post-exercise biphasic response of the brachial endothelial function. Participants reported to the laboratory in a fasting state (≥ 4h) and refrained from vigorous exercise, vitamin supplements, foods/drinks containing caffeine, and alcohol for at least 24h before each session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –A non-exercise condition. |
| High intensity interval exercise (HIIE) | Experimental | Other: High-intensity interval exerciseThe 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). |
| Moderate-intensity exercise (MICE) | Experimental | Other: Moderate continuous exerciseMICE at 60% V̇O2 reserve with the duration adjusted to each participant so that each participant achieved the target energy expenditure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Cardiovascular disease (e.g., heart failure, ischemic heart disease)
- Orthostatic intolerance
- Thyroid dysfunction
- Mental disease
- Microvascular complications (e.g., neuropathies)
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 exerciseThe 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. | Other | High intensity interval exercise (HIIE) |
| Moderate continuous exerciseAlso: MICEEnergy 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. | Other | Moderate-intensity exercise (MICE) |
Primary outcome
Brachial endothelial function
Time frame: Before and 10, and 60-minutes after acute aerobic exercise
Brachial artery flow-mediated dilation - ultrasound
Brachial artery stiffness
Time frame: Before and 5, and 60-minutes after acute aerobic exercise
Brachial artery flow-mediated slowing - ultrasound
3 secondary outcomes
Central arterial stiffness
Time frame: Before and 10, and 60-minutes after acute aerobic exercise
Upper limb arterial stiffness
Time frame: Before and 10, and 60-minutes after acute aerobic exercise
Lower limb arterial stiffness
Time frame: Before and 10, and 60-minutes after acute aerobic exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 28567668Francois 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.
- Results publication: PubMed 30885194Magalhaes 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.
- Results publication: PubMed 21084931Colberg 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.
- Results publication: PubMed 30115967Fiuza-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.
- Results publication: PubMed 25281334Ashor 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.
- Results publication: PubMed 26209709Ellins 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.
- Results publication: PubMed 16267075Naka 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.
- Results publication: PubMed 31211361Thijssen 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.
- Results publication: PubMed 26994427Cahill 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Xavier Melo, PhD principal investigator
Egas Moniz School of Health & Science
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 exercise and Moderate continuous exercise in people with Diabetes Mellitus, Type 2, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 9 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: finished, as of the sponsor's last update on 12 Nov 2024. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial endothelial function (time frame: Before and 10, and 60-minutes after acute aerobic exercise). The study lists 2 primary outcomes in all. 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 NCT06684912, which also lists 9 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 12 Nov 2024.