Diabetic CardiomyopathiesNCT03299790
Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
A study testing high-intensity interval exercise training (HIIT) and moderate-intensity exercise training (MIT) in people with Diabetic Cardiomyopathies and Type2 Diabetes, run by Hasselt University at 1 site in Belgium.
Trial summary
According to data of the International Diabetes Federation (IDF), diabetes in general affects approximately 415 million people worldwide and this number is still increasing. Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of mortality and morbidity in the diabetic population. Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Cardiomyopathies, Type2 Diabetes
- What is being tested?
- high-intensity interval exercise training (HIIT) and moderate-intensity exercise training (MIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Oct 2017to 30 Sep 2020
- 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 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- type 2 diabetes patients:
- BMI > 20kg/m²
- diagnosis of T2DM as stated in guidelines of ADA (American Diabetes Association)
- stable medication for at least 3 months
- Healthy controls:
- BMI > 20kg/m²
- no diabetes
Who cannot join
- iron deficiency anemia
- participation in another clinical trial
- heart diseases: CAD (coronary artery disease), ischemia, valvular diseases, congenital heart diseases
- neurological, pneumological, oncological, orthopedic disorders
- diabetes complications: renal diseases, retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
According to data of the International Diabetes Federation (IDF), diabetes in general affects approximately 415 million people worldwide and this number is still increasing. Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of mortality and morbidity in the diabetic population. One of the cardiovascular complications is diabetic cardiomyopathy, in which structural and functional changes occur in the heart impairing cardiac function.
Exercise training has already proven the benefits on glycemic control in diabetes. This is also the case for the effects on cardiac function. However, as results are conflicting, it remains unclear which elements of exercise training should be focused on. For instance, high-intensity interval training (HIIT) is gaining interest as positive effects are already shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in diabetes should be investigated. Further on, the effects of exercise training on cardiac function are mainly investigated during rest by the use of transthoracic echocardiography. Therefore, as data are lacking, it remains unclear how the diabetic heart functions during exercise.
Read more
The aim of the present study is to investigate the effects of different training modalities (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself. Therefore, cardiac function will be evaluated by the use transthoracic (exercise) echocardiography. This will be combined by the evaluation of several biochemical parameters.
The results will provide more insight in the pathology of diabetic cardiomyopathy as well as the potential of exercise training for this cardiovascular complication. Eventually, this research will contribute to the optimization of exercise programs for patients with diabetes.
- Conditions
- Diabetic Cardiomyopathies, Type2 Diabetes
- Being tested
- high-intensity interval exercise training (HIIT), moderate-intensity exercise training (MIT)
- Keywords
- Type 2 diabetes, Diabetic cardiomyopathy, Cardiac function, Exercise echocardiography, Exercise training
- Medical subject headings
- Diabetic Cardiomyopathies, 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 exercise training (HIIT)Other
This program includes 24 weeks of exercise training and is divided in different phases (phase 1: week 1-2, equal to the MIT group, phase 2: week 3-6, 6 bouts of high-intensity exercise, phase 3: week 7-12, 7 bouts of high-intensity exercise, phase 4: week 13-24, 8 bouts of high-intensity exercise). The exercise training program consists of 3 exercise sessions per week (for 6 months).
moderate-intensity exercise training (MIT)Other
This program includes 24 weeks of exercise training and is not devided in phases. The exercise training program consists of 3 endurance exercise sessions per week (for 6 months). The total exercise volume equals the exercise volume of the HIIT group.
| Study group | Role | What they receive |
|---|---|---|
| training group 1: HIIT | Active comparator | high-intensity interval exercise training group (T2DM patients) Receives: Other: high-intensity interval exercise training (HIIT) |
| training group 2: MIT | Active comparator | moderate-intensity exercise training group (T2DM patients) Receives: Other: moderate-intensity exercise training (MIT) |
| Detraining period | No intervention | Follow-up: detraining of group 1 and 2 (T2DM patients) |
| Healthy controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transthoracic echocardiography (TTE) during excercise
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: day 1
Transthoracic echocardiography (TTE) during excercise
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: month 3
Transthoracic echocardiography (TTE) during excercise
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: month 6
Transthoracic echocardiography (TTE) during excercise
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: month 12
Transthoracic echocardiography (TTE)
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: day 1
Transthoracic echocardiography (TTE)
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: month 3
Transthoracic echocardiography (TTE)
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: month 6
Transthoracic echocardiography (TTE)
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Measured: month 12
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
Measured: month 3
ECG (Electrocardiogram) during excercise
ECG during excercise (an incremental exercise test on a cycle)
Measured: month 12
ECG (Electrocardiogram)
ECG in rest
Measured: month 3
ECG (Electrocardiogram)
ECG in rest
Measured: month 12
Secondary outcomes (22)
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Measured: day 1
Glycemic control
glycemic control, insulin sensitivity, inflammation, cardiac biomarkers
Measured: month 3
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Measured: month 6
Glycemic control
glycemic concentrations, HbA1c levels, insulin sensitivity, inflammation, cardiac biomarkers
Measured: month 12
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Measured: day 1
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Measured: month 3
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Measured: month 6
Insulin metabolism
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
Measured: month 12
Cardiac function
Cardiac biomarkers (brain-derived natriuretic peptide (BNP) levels, cardiac troponin levels)
Measured: day 1
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Measured: month 3
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Measured: month 6
Cardiac function
Cardiac biomarkers (BNP levels, cardiac troponin levels)
Measured: month 12
Inflammation and oxidative stress
C reactive protein (CRP) levels, tumor necrosis factor-(TNF)alpha levels, interleukin (IL)-10 (interleukin) levels, oxidative stress markers (superoxide dismutase (SOD), malondialdehyde (MDA), glutathione peroxidase (GPX))
Measured: day 1
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Measured: month 3
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA , GPX)
Measured: month 6
Inflammation and oxidative stress
CRP levels, TNF-alpha levels, IL-10 levels, oxidative stress markers (SOD, MDA, GPX)
Measured: month 12
body composition
body composition, measured using dual x-ray absorptiometry
Measured: day 1
body composition
body composition, measured using dual x-ray absorptiometry
Measured: month 6
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Measured: day 1
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Measured: month 3
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Measured: month 6
Maximal oxygen uptake (ml/O2/kg/min)
exercise capacity measured using indirect calorimetry and an incremental bicycle exercise protocol
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start6 Oct 2017
- Primary completion31 Dec 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic CardiomyopathiesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299790
- Sponsor's protocol ID
- HITDCM01
- Status last verified
- Dec 2020
- First submitted
- 12 Sep 2017
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Ryckeghem L, Keytsman C, De Brandt J, Verboven K, Verbaanderd E, Marinus N, Franssen WMA, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Impact of continuous vs. interval training on oxygen extraction and cardiac function during exercise in type 2 diabetes mellitus. Eur J Appl Physiol. 2022 Apr;122(4):875-887. doi: 10.1007/s00421-022-04884-9. Epub 2022 Jan 17.
PubMed 35038022Van Ryckeghem L, Keytsman C, Verboven K, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Exercise capacity is related to attenuated responses in oxygen extraction and left ventricular longitudinal strain in asymptomatic type 2 diabetes patients. Eur J Prev Cardiol. 2022 Jan 11;28(16):1756-1766. doi: 10.1093/eurjpc/zwaa007.
PubMed 33623980Van Ryckeghem L, Keytsman C, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Asymptomatic type 2 diabetes mellitus display a reduced myocardial deformation but adequate response during exercise. Eur J Appl Physiol. 2021 Mar;121(3):929-940. doi: 10.1007/s00421-020-04557-5. Epub 2021 Jan 8.
PubMed 33417036
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03299790
- Acronym / sponsor ID
- HITDCM01
- Conditions
- Diabetic Cardiomyopathies, Type2 Diabetes
- Keywords
- Type 2 diabetes, Diabetic cardiomyopathy, Cardiac function, Exercise echocardiography, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 3 Oct 2017 (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.
According to data of the International Diabetes Federation (IDF), diabetes in general affects approximately 415 million people worldwide and this number is still increasing. Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of mortality and morbidity in the diabetic population. One of the cardiovascular complications is diabetic cardiomyopathy, in which structural and functional changes occur in the heart impairing cardiac function.
Exercise training has already proven the benefits on glycemic control in diabetes. This is also the case for the effects on cardiac function. However, as results are conflicting, it remains unclear which elements of exercise training should be focused on. For instance, high-intensity interval training (HIIT) is gaining interest as positive effects are already shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in diabetes should be investigated. Further on, the effects of exercise training on cardiac function are mainly investigated during rest by the use of transthoracic echocardiography. Therefore, as data are lacking, it remains unclear how the diabetic heart functions during exercise.
The aim of the present study is to investigate the effects of different training modalities (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself. Therefore, cardiac function will be evaluated by the use transthoracic (exercise) echocardiography. This will be combined by the evaluation of several biochemical parameters.
The results will provide more insight in the pathology of diabetic cardiomyopathy as well as the potential of exercise training for this cardiovascular complication. Eventually, this research will contribute to the optimization of exercise programs for patients with diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| training group 1: HIIT | Active comparator | Other: high-intensity interval exercise training (HIIT)high-intensity interval exercise training group (T2DM patients) |
| training group 2: MIT | Active comparator | Other: moderate-intensity exercise training (MIT)moderate-intensity exercise training group (T2DM patients) |
| Detraining period | No intervention | –Follow-up: detraining of group 1 and 2 (T2DM patients) |
| Healthy controls | No intervention | – |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 2 diabetes patients:
- Healthy controls:
Key exclusion criteria (5 listed)
- iron deficiency anemia
- participation in another clinical trial
- heart diseases: CAD (coronary artery disease), ischemia, valvular diseases, congenital heart diseases
- neurological, pneumological, oncological, orthopedic disorders
- diabetes complications: renal diseases, retinopathy
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 exercise training (HIIT)This program includes 24 weeks of exercise training and is divided in different phases (phase 1: week 1-2, equal to the MIT group, phase 2: week 3-6, 6 bouts of high-intensity exercise, phase 3: week 7-12, 7 bouts of high-intensity exercise, phase 4: week 13-24, 8 bouts of high-intensity exercise). The exercise training program consists of 3 exercise sessions per week (for 6 months). | Other | training group 1: HIIT |
| moderate-intensity exercise training (MIT)This program includes 24 weeks of exercise training and is not devided in phases. The exercise training program consists of 3 endurance exercise sessions per week (for 6 months). The total exercise volume equals the exercise volume of the HIIT group. | Other | training group 2: MIT |
Primary outcome
Transthoracic echocardiography (TTE) during excercise
Time frame: day 1
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE) during excercise
Time frame: month 3
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE) during excercise
Time frame: month 6
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE) during excercise
Time frame: month 12
heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE)
Time frame: day 1
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE)
Time frame: month 3
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE)
Time frame: month 6
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
Transthoracic echocardiography (TTE)
Time frame: month 12
heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)
ECG (Electrocardiogram) during excercise
Time frame: month 3
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram) during excercise
Time frame: month 12
ECG during excercise (an incremental exercise test on a cycle)
ECG (Electrocardiogram)
Time frame: month 3
ECG in rest
ECG (Electrocardiogram)
Time frame: month 12
ECG in rest
22 secondary outcomes
Glycemic control
Time frame: day 1
Glycemic control
Time frame: month 3
Glycemic control
Time frame: month 6
Glycemic control
Time frame: month 12
Insulin metabolism
Time frame: day 1
Insulin metabolism
Time frame: month 3
Insulin metabolism
Time frame: month 6
Insulin metabolism
Time frame: month 12
Cardiac function
Time frame: day 1
Cardiac function
Time frame: month 3
Cardiac function
Time frame: month 6
Cardiac function
Time frame: month 12
Inflammation and oxidative stress
Time frame: day 1
Inflammation and oxidative stress
Time frame: month 3
Inflammation and oxidative stress
Time frame: month 6
Inflammation and oxidative stress
Time frame: month 12
body composition
Time frame: day 1
body composition
Time frame: month 6
Maximal oxygen uptake (ml/O2/kg/min)
Time frame: day 1
Maximal oxygen uptake (ml/O2/kg/min)
Time frame: month 3
Maximal oxygen uptake (ml/O2/kg/min)
Time frame: month 6
Maximal oxygen uptake (ml/O2/kg/min)
Time frame: month 12
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 10 Dec 2020.
- Derived from this study: PubMed 35038022Van Ryckeghem L, Keytsman C, De Brandt J, Verboven K, Verbaanderd E, Marinus N, Franssen WMA, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Impact of continuous vs. interval training on oxygen extraction and cardiac function during exercise in type 2 diabetes mellitus. Eur J Appl Physiol. 2022 Apr;122(4):875-887. doi: 10.1007/s00421-022-04884-9. Epub 2022 Jan 17.
- Derived from this study: PubMed 33623980Van Ryckeghem L, Keytsman C, Verboven K, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Exercise capacity is related to attenuated responses in oxygen extraction and left ventricular longitudinal strain in asymptomatic type 2 diabetes patients. Eur J Prev Cardiol. 2022 Jan 11;28(16):1756-1766. doi: 10.1093/eurjpc/zwaa007.
- Derived from this study: PubMed 33417036Van Ryckeghem L, Keytsman C, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Asymptomatic type 2 diabetes mellitus display a reduced myocardial deformation but adequate response during exercise. Eur J Appl Physiol. 2021 Mar;121(3):929-940. doi: 10.1007/s00421-020-04557-5. Epub 2021 Jan 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 training (HIIT) and moderate-intensity exercise training (MIT) in people with Diabetic Cardiomyopathies and Type2 Diabetes, run by Hasselt University at 1 site in Belgium.
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 7 inclusion and 5 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 10 Dec 2020. 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 Belgium. 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?
Transthoracic echocardiography (TTE) during excercise (time frame: day 1). The study lists 12 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 NCT03299790, which also lists 3 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 10 Dec 2020.