Type 2 DiabetesPROTECTIONNCT05023538
Prevention of Heart Failure in Type 2 Diabetes by Exercise Intervention
A study testing Cycling in people with Type 2 Diabetes, run by Hasselt University at 2 sites in Belgium.
Trial summary
Global longitudinal strain emerged as an important predictive marker that could be assessed during echocardiography. It enabled the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before diabetes induced heart… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Mar 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physically inactive (no participation in structured or unstructured physical activity (PA) and not reaching the recommended PA guidelines: initially based on the International Physical Activity Questionnaire )
- age between 30-75 years
- blood HbA1c of 6-10% (if taking blood glucose lowering medication) or 6.5-10% without taking blood glucose lowering medication, and/or two-hour plasma glucose ≥11.1 mmol/L or ≥200 mg/dL following a 75g oral glucose load during OGTT.
- women of child bearing age will be included into the trial.
Who cannot join
- exogenous insulin therapy
- individuals suffering from any disease with significant impact on exercise intervention participation, such as: chronic heart disease or significant arrhythmias, cardiac events (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), chronic obstructive pulmonary, cerebrovascular or peripheral vascular disease, severe hypertension (>160/110 mmHg), cancer, severe neuropathy (limiting exercise participation).
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University
Hasselt, Belgium, 3590
Faculty of Movement and Rehabilitation Sciences
Leuven, Belgium, 3000
About this study
Official title: PROTECTION Study: PReventiOn of HearT Failure in Type 2 Diabetes by ExerCise InTerventION
Global longitudinal strain emerged as an important predictive marker that could be assessed during echocardiography. It enabled the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before diabetes induced heart failure. In asymptomatic T2D patients with no history of cardiovascular disease, an impaired global longitudinal strain is a predictor of future adverse left ventricular remodeling and adverse cardiovascular events. Exercise training is a promising intervention to interfere in the diabetes induced heart failure pathophysiology. However, the impact of different exercise modalities (e.g. intensity and volume) on the global longitudinal strain in type 2 diabetes (T2D) is unknown.
Read the detailed description
More than 400 million people worldwide are affected by diabetes mellitus whose prevalence keeps increasing. In type 2 diabetes mellitus (T2DM), up to 23% of the patients have asymptomatic diastolic and 13% systolic cardiac dysfunction. Diabetes-induced heart failure (DIHF), with reduced or preserved ejection fraction, is thus one of the major complications of T2DM, which is characterized by structural and functional changes in the myocardium in absence of coronary artery disease, other cardiac pathologies or hypertension. These changes significantly affect prognosis: patients with DIHF are at a 147% elevated risk for premature death within 4 years vs. 29% in patients without DIHF. It is thus of the utmost importance to prevent the development of DIHF. Although the exact mechanisms are not fully understood, hyperglycemia, hyperinsulinemia and hyperlipidemia are considered as key risk factors, but also oxidative and dicarbonyl stress, advanced glycation end products (AGEs) and inflammation play an important role in the pathophysiology of DIHF.
To prevent adverse cardiac remodeling in T2DM and the development of DIHF, early biomarkers are mandatory. In this respect, in the past few years global longitudinal strain (GLS) emerged as an important predictive marker that could be assessed during echocardiography: the global longitudinal strain enables the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before DIHF. In asymptomatic T2DM patients with no history of cardiovascular disease, an impaired GLS is a predictor of future adverse left ventricular (LV) remodeling and adverse cardiovascular events, thus providing incremental prognostic value beyond clinical data, glycated hemoglobin (HbA1c) and diastolic function. The investigators found that GLS is indeed significantly lowered (by ±14%, at rest and during low-intense and high-intense exercise, in asymptomatic well-controlled T2DM patients (HbA1c: 6.9±0.7%). During exercise, GLS increases in T2DM, but fails to normalize when compared with healthy controls. In contrast to current assumption, the investigators' data demonstrate that a disturbed GLS is highly common in T2DM patients.
Exercise training is strongly recommended to T2DM patients, and is a crucial treatment next to medication and diet, as this (further) optimizes glycemic control by improving insulin sensitivity, next to the positive impact on physical fitness, blood pressure, lipid profile and body composition. Recent evidence also indicates a significantly lowered mortality in habitual physically active vs. non-active T2DM patients (hazard ratio=0.61).
What type of exercise is most effective? What remains debatable is whether exercise intervention can prevent the development of DIHF in asymptomatic T2DM patients. According to a recent systematic review from the investigators' laboratory, the impact of exercise intervention on GLS in asymptomatic T2DM is equivocal: significant improvements from some studies could not be reproduced in other. In line with these findings, the investigators' unpublished pilot data also reveal the capability of exercise training to improve GLS in some T2DM patients.
The investigators' data show the potency of exercise in preventing DIHF in asymptomatic T2DM patients, but they also show that crucial aspects deserve further study to maximize the benefits of exercise training on GLS in T2DM patients, and hereby to offer maximal protection against the development of DIHF.
The impact of different exercise modalities (e.g. intensity, volume) on GLS in T2DM patients is currently unknown. In the only clinical study that examined T2MD patients to date, results show that high-intense interval training is more effective to improve GLS, as opposed to moderate-intense exercise training. However, the study is biased due to the lack of supervision in the moderate-intense trained group and the lack of control for equal caloric expenditure between training groups. Therefore, it is likely that differences in exercise volume could be at the basis of different changes in GLS between groups. Indeed, the investigators' pilot data, in which iso-caloric interventions were compared, show different results: moderate-intense exercise training seems more potent to improve GLS, as opposed to high-intense interval training. As a result, although there is evidence that exercise training improves GLS in T2DM patients, it remains to be studied whether different volumes or intensities are of key importance.
Despite following identical exercise interventions, studies and the investigators' pilot data also show significant inter-subject variances in changes in GLS. Therefore, the impact of the patient's phenotype, as well as habitual physical activity (PA) and dietary habits, on the effects of exercise training on GLS in T2DM patients is currently unknown. Revealing which (non-)modifiable patient-related factors (e.g. phenotype, habitual PA and dietary habits) predict the responsiveness of GLS to exercise intervention in T2DM patients may lead to a more patient-specific application of such intervention or further tailoring of the intervention.
- Conditions
- Type 2 Diabetes
- Being tested
- Cycling
- Keywords
- T2D, exercise, rehabilitation, training, global longitudinal strain, echocardiography, heart, cardiac remodelling
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclingOther
Exercise on bicycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No intervention |
| Low-volume moderately-intense exercise | Experimental | exercise at 50-65%VO2peak; 20-30min/training session, 3x/week, 6 months Receives: Other: Cycling |
| High-volume moderately-intense exercise | Experimental | exercise at 50-65%VO2peak; 20-50min/training session, 3x/week, 6 months Receives: Other: Cycling |
| Low-volume high-intense exercise | Experimental | exercise at 50-85%VO2peak; 20-30min/training session, 3x/week, 6 months Receives: Other: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
mPAP/CO and mPAP/CO slope
- Mean pulmonary artery pressure by cardiac output and by cardiac output slope
- mPAP/CO slope will be calculated via measurement of LVOTdiameter, LVOT VTI and sPAP at three timepoints during exercise echocardiography. These timepoints are: rest, low intense exercise (HR\<100 before fusion of early and late mitral inflow (E \& A)), and high-intense exercise (RER 1.02-1.05).
Measured: at baseline and 6 months
Global longitudinal strain (%)
Cardiac function evaluation by echocardiography at rest
Measured: at baseline and 6 months
Secondary outcomes (5)
Fasted Blood draw
lipid profile (HDL, LDL, triglicerides, free fatty acids, total cholesterol) glycemic profile (Hba1c, fasting glucose and insulin) kidney function (eGFR, creatinine)
Measured: baseline, 3m and 6m
Cardiopulmonary exercise testing on a bicycle
Peak CPET values:
Load, HR, VE, Bf, SBP, DBP, VO2, VCO2, RER, VE/VCO2, VE/VO2, SpO2, PETCO2, PETO2, BR
Measured: baseline, 3m and 6m
Rest and exercise echocardiography
Supine resting echocardiography
- Structure (LVOTd, IVSd, LVEDD, PWd, RWT, LVMI)
- Function (LVOT VTI, LVEDV biplane, LVESV biplane, Evel, A vel, e\' sep, e\' lat, VCI exp, VCI ins, RAP, TR velocity, TRPG, PASP, GLS, TAPSE, LAVI)
Semisupine exercise echocardiography at rest, low-intensity exercise (HR\<100) and high-intensity exercise (RER 1.2-1.05)
- Function (LVOT VTI, RVAd, RVAs, TAPSE, MAPSE, LVEDV biplane, LVESV biplane, LVEF, Evel, Avel, e\'sep, e\'lat, LV s\'sep, LV s\'lat, RV s\' sep, TRPG, RAP, SV, CO, GLS
Pulmonary circulation mPAP rest, mPAP low-intensity, mPAP high-intensity, mPAP/CO, mPAP/CO slope
Measured: baseline and 6m
Physical activity via Actigraph wGT3X-BT
PA measurement during waking hours in the period of 7 days with minimal valid time of 2 week and 2 weekend days. Total volume of PA is calculated via vector magnitude after raw data processing via GGIR script in Rstudio. Calculation of average steps/day is performed via Actilife software v6.13.5.
Measured: baseline, 3 and 6 months
Body composition (%fat) via bioelectrical impedance
Measurement of % lean and fat-mass via Bodystaat 1500 device
Other variables:
- waist circumference via cm tape on the level of umbilicus
- hip circumference via cm tape on the level of major trochanter
- body mass via analog scale
- body height via vertical cm tape
Measured: baseline, 3 and 6m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Mar 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled trial and a cohort study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, KU Leuven, University Ghent
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023538
- Sponsor's protocol ID
- Version 1, 10/06/2021
- Acronym
- PROTECTION
- Status last verified
- Sep 2024
- First submitted
- 24 Jun 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECTION Study: PReventiOn of HearT Failure in Type 2 Diabetes by ExerCise InTerventION
- ClinicalTrials.gov ID
- NCT05023538
- Acronym / sponsor ID
- PROTECTION / Version 1, 10/06/2021
- Conditions
- Type 2 Diabetes
- Keywords
- T2D, exercise, rehabilitation, training, global longitudinal strain, echocardiography, heart, cardiac remodelling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, KU Leuven, University Ghent
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 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.
Global longitudinal strain emerged as an important predictive marker that could be assessed during echocardiography. It enabled the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before diabetes induced heart failure. In asymptomatic T2D patients with no history of cardiovascular disease, an impaired global longitudinal strain is a predictor of future adverse left ventricular remodeling and adverse cardiovascular events. Exercise training is a promising intervention to interfere in the diabetes induced heart failure pathophysiology. However, the impact of different exercise modalities (e.g. intensity and volume) on the global longitudinal strain in type 2 diabetes (T2D) is unknown.
Detailed description
More than 400 million people worldwide are affected by diabetes mellitus whose prevalence keeps increasing. In type 2 diabetes mellitus (T2DM), up to 23% of the patients have asymptomatic diastolic and 13% systolic cardiac dysfunction. Diabetes-induced heart failure (DIHF), with reduced or preserved ejection fraction, is thus one of the major complications of T2DM, which is characterized by structural and functional changes in the myocardium in absence of coronary artery disease, other cardiac pathologies or hypertension. These changes significantly affect prognosis: patients with DIHF are at a 147% elevated risk for premature death within 4 years vs. 29% in patients without DIHF. It is thus of the utmost importance to prevent the development of DIHF. Although the exact mechanisms are not fully understood, hyperglycemia, hyperinsulinemia and hyperlipidemia are considered as key risk factors, but also oxidative and dicarbonyl stress, advanced glycation end products (AGEs) and inflammation play an important role in the pathophysiology of DIHF.
To prevent adverse cardiac remodeling in T2DM and the development of DIHF, early biomarkers are mandatory. In this respect, in the past few years global longitudinal strain (GLS) emerged as an important predictive marker that could be assessed during echocardiography: the global longitudinal strain enables the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before DIHF. In asymptomatic T2DM patients with no history of cardiovascular disease, an impaired GLS is a predictor of future adverse left ventricular (LV) remodeling and adverse cardiovascular events, thus providing incremental prognostic value beyond clinical data, glycated hemoglobin (HbA1c) and diastolic function. The investigators found that GLS is indeed significantly lowered (by ±14%, at rest and during low-intense and high-intense exercise, in asymptomatic well-controlled T2DM patients (HbA1c: 6.9±0.7%). During exercise, GLS increases in T2DM, but fails to normalize when compared with healthy controls. In contrast to current assumption, the investigators' data demonstrate that a disturbed GLS is highly common in T2DM patients.
Exercise training is strongly recommended to T2DM patients, and is a crucial treatment next to medication and diet, as this (further) optimizes glycemic control by improving insulin sensitivity, next to the positive impact on physical fitness, blood pressure, lipid profile and body composition. Recent evidence also indicates a significantly lowered mortality in habitual physically active vs. non-active T2DM patients (hazard ratio=0.61).
What type of exercise is most effective? What remains debatable is whether exercise intervention can prevent the development of DIHF in asymptomatic T2DM patients. According to a recent systematic review from the investigators' laboratory, the impact of exercise intervention on GLS in asymptomatic T2DM is equivocal: significant improvements from some studies could not be reproduced in other. In line with these findings, the investigators' unpublished pilot data also reveal the capability of exercise training to improve GLS in some T2DM patients.
The investigators' data show the potency of exercise in preventing DIHF in asymptomatic T2DM patients, but they also show that crucial aspects deserve further study to maximize the benefits of exercise training on GLS in T2DM patients, and hereby to offer maximal protection against the development of DIHF.
The impact of different exercise modalities (e.g. intensity, volume) on GLS in T2DM patients is currently unknown. In the only clinical study that examined T2MD patients to date, results show that high-intense interval training is more effective to improve GLS, as opposed to moderate-intense exercise training. However, the study is biased due to the lack of supervision in the moderate-intense trained group and the lack of control for equal caloric expenditure between training groups. Therefore, it is likely that differences in exercise volume could be at the basis of different changes in GLS between groups. Indeed, the investigators' pilot data, in which iso-caloric interventions were compared, show different results: moderate-intense exercise training seems more potent to improve GLS, as opposed to high-intense interval training. As a result, although there is evidence that exercise training improves GLS in T2DM patients, it remains to be studied whether different volumes or intensities are of key importance.
Despite following identical exercise interventions, studies and the investigators' pilot data also show significant inter-subject variances in changes in GLS. Therefore, the impact of the patient's phenotype, as well as habitual physical activity (PA) and dietary habits, on the effects of exercise training on GLS in T2DM patients is currently unknown. Revealing which (non-)modifiable patient-related factors (e.g. phenotype, habitual PA and dietary habits) predict the responsiveness of GLS to exercise intervention in T2DM patients may lead to a more patient-specific application of such intervention or further tailoring of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Single-blind randomized controlled trial and a cohort study.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No intervention |
| Low-volume moderately-intense exercise | Experimental | Other: Cyclingexercise at 50-65%VO2peak; 20-30min/training session, 3x/week, 6 months |
| High-volume moderately-intense exercise | Experimental | Other: Cyclingexercise at 50-65%VO2peak; 20-50min/training session, 3x/week, 6 months |
| Low-volume high-intense exercise | Experimental | Other: Cyclingexercise at 50-85%VO2peak; 20-30min/training session, 3x/week, 6 months |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- physically inactive (no participation in structured or unstructured physical activity (PA) and not reaching the recommended PA guidelines: initially based on the International Physical Activity Questionnaire )
- age between 30-75 years
- blood HbA1c of 6-10% (if taking blood glucose lowering medication) or 6.5-10% without taking blood glucose lowering medication, and/or two-hour plasma glucose ≥11.1 mmol/L or ≥200 mg/dL following a 75g oral glucose load during OGTT.
- women of child bearing age will be included into the trial.
Key exclusion criteria (2 listed)
- exogenous insulin therapy
- individuals suffering from any disease with significant impact on exercise intervention participation, such as: chronic heart disease or significant arrhythmias, cardiac events (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), chronic obstructive pulmonary, cerebrovascular or peripheral vascular disease, severe hypertension (>160/110 mmHg), cancer, severe neuropathy (limiting exercise participation).
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 |
|---|---|---|
| CyclingExercise on bicycle ergometer | Other | High-volume moderately-intense exercise, Low-volume high-intense exercise, Low-volume moderately-intense exercise |
Primary outcome
mPAP/CO and mPAP/CO slope
Time frame: at baseline and 6 months
* Mean pulmonary artery pressure by cardiac output and by cardiac output slope * mPAP/CO slope will be calculated via measurement of LVOTdiameter, LVOT VTI and sPAP at three timepoints during exercise echocardiography. These timepoints are: rest, low intense exercise (HR\&amp;lt;100 before fusion of early and late mitral inflow (E \&amp;amp; A)), and high-intense exercise (RER 1.02-1.05).
Global longitudinal strain (%)
Time frame: at baseline and 6 months
Cardiac function evaluation by echocardiography at rest
5 secondary outcomes
Fasted Blood draw
Time frame: baseline, 3m and 6m
Cardiopulmonary exercise testing on a bicycle
Time frame: baseline, 3m and 6m
Rest and exercise echocardiography
Time frame: baseline and 6m
Physical activity via Actigraph wGT3X-BT
Time frame: baseline, 3 and 6 months
Body composition (%fat) via bioelectrical impedance
Time frame: baseline, 3 and 6m
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling in people with Type 2 Diabetes, run by Hasselt University at 2 sites 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
mPAP/CO and mPAP/CO slope (time frame: at baseline and 6 months). 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?
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 25 Sep 2024.