Type 2 Diabetes Clinical Trial
— PROTECTIONOfficial 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.
Status | Recruiting |
Enrollment | 182 |
Est. completion date | June 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Belgium | Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University | Hasselt | |
Belgium | Faculty of Movement and Rehabilitation Sciences | Leuven |
Lead Sponsor | Collaborator |
---|---|
Hasselt University | Jessa Hospital, KU Leuven, University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global longitudinal strain (%) | Cardiac function evaluation by echocardiography at rest and during maximal exercise testing | 6 months | |
Secondary | Waist circumference (cm) | Physical examination | pre-post 6 months | |
Secondary | Body mass (kg) | Physical examination | pre-post 6 months | |
Secondary | HbA1c (mmol/mol) | Physical examination | pre-post 6 months | |
Secondary | Blood Glucose (mmol/L) | Physical examination | pre-post 6 months | |
Secondary | Insulin (mIU/L) | Physical examination | pre-post 6 months | |
Secondary | Blood lipid profile (total cholesterol, HDL, LDL, free fatty acids, triglycerides; mmol/L) | Physical examination | pre-post 6 months | |
Secondary | Peak VO2(L) | Incremental cardiopulmonary exercise test on a bicycle | pre-post 6 months | |
Secondary | 2nd Ventilatory Treshold (%VO2peak) | Incremental cardiopulmonary exercise test on a bicycle | pre-post 6 months | |
Secondary | Maximal work-rate(W) | Incremental cardiopulmonary exercise test on a bicycle | pre-post 6 months | |
Secondary | International Physical Activity Questionnaire (MET-min/week) | Physical activity level during 7 days | pre-post 6 months | |
Secondary | Physical activity measurement (MET-min/week; kcal/week; steps/day; ) | With ActiGraph wGT3X-BT worn on a wrist during a 1-week period. Used to obtain activity counts, energy expenditure, MET rates and steps taken. | pre-post 6 months | |
Secondary | Sleep quality measurement (total sleep time (h)) | With ActiGraph wGT3X-BT worn on a wrist during a 1-week period. | pre-post 6 months | |
Secondary | Dietary intake (kcal/day) | 5-day food diary | pre-post 6 months | |
Secondary | Calf muscle oxygen saturation (haemoglobin variables: ?HHb, ?tHb, ?HbO2 and ?TSI%) | Measured at the middle of the vastus lateralis muscle during the cardiopulomonary cycling test via non-invasive near-infrared spectroscopy (NIRS - PortaMon from ARTINIS). | pre-post 6 months |
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