Obesity Clinical Trial
— PolyCADOfficial title:
Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial
The present study is testing spermidine treatment in elderly patients with coronary artery disease. The study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | January 2027 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age = 65 years - Chronic ischemic heart disease (previous revascularization or myocardial infarction) - Left ventricular ejection fraction of > 40% And at least two of the following risk factors: - Type 2 diabetes, - Obesity (BMI = 30 kg/m2), - Hypertension, - Previous LVEF < 40%, - Left atrial volume index = 30 mL/m2 - Left ventricular wall thickness = 1.1 cm. Exclusion Criteria: - Unstable coronary syndrome - Significant and severe cardiac valve disease - Severe peripheral artery disease - Permanent atrial fibrillation - Pacemaker treatment - Chronic kidney disease with eGFR <45 ml/min/1,73m2 - Severe comorbidity as judged by the investigator (such as severe pulmonary, neurological, or musculoskeletal disease) - Inability to give informed consent. Exclusion criteria for MRI: - Some metallic implants - Claustrophobia Exclusion criteria for muscle biopsy: - Treatment with either two antiplatelet drugs (aspirin and ADP-receptor antagonists) - Anticoagulants (warfarin, NOACs) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | Jutland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Danish Cardiovascular Academy (DCA), Danish Diabetes Academy, DoNotAge.org, Eva and Henry Frænkels Mindefond, Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital, Sygesikringen Danmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in gut microbiota | 16S RNA analysis will be used for characterization of the bacterial composition.
Full sequencing will be used for characterisation of the collective composition of bacteria, viruses, bacteriophages, fungi, and parasites. |
From randomization (month 0) to 12 months | |
Other | Changes in fecal metabolites | Mass spectrometric metabolome analyses will be used for assessing fecal metabolites before and after intervention. | From randomization (month 0) to 12 months | |
Other | Skeletal muscle quality assesment | An explorative analysis of skeletal muscle quality including MRI with Dixon method, fiber CSA and type composition, tissue vascularity, morphology and architecture of skeletal muscle biopsy taken from vastus lateralis. | From randomization (month 0) to 12 months | |
Other | Explorative analysis of adipose tissue | Measurement of enzymes involved in lipid storage. FACS to examine the cellular composition of the adipose tissue sample and to allow downstream PCR analysis of DNA/RNA or western blot analysis of proteins from specific cell populations or from non-sorted biopsy material. | From randomization (month 0) to 12 months | |
Other | Explorative analysis of skeletal muscle tissue | FACS to examine the cellular composition and to allow downstream PCR analysis of DNA/RNA or western blot analysis of proteins from specific cell populations or from non-sorted biopsy material. RNA sequencing, and protein content will be assessed as metabolomics and proteomics by mass-spectrometry. | From randomization (month 0) to 12 months | |
Other | Whole body metabolism | Changes in circulating metabolic markers | From randomization (month 0) to 12 months | |
Other | Muscle metabolism | Changes in metabolic signature of muscle tissue assessed by liquid chromatography-high-resolution mass spectrometry | From randomization (month 0) to 12 months | |
Other | Skeletal muscle satellite cell (MuSC) proliferation assays | Proliferation and differentiation analysis in cell numbers and cell viability of MuSC | From randomization (month 0) to 12 months | |
Primary | Change in left ventricular mass | Measured with Cardiac Magnetic Resonance Imaging (CMR). | From randomization (month 0) to 12 months | |
Primary | Change in appendicular lean mass and ALM index | Appendicular lean mass and ALM index (Appendicular lean mass/height^2). Measured by a whole-body dual-energy X ray absorptiometry (DXA) scan. | From randomization (month 0) to 12 months | |
Primary | Change in High-sensitivity C-reactive Protein (hs-CRP) | Measured from blood samples. | From randomization (month 0) to 12 months | |
Primary | Change in Physical performance, peak oxygen consumption (VO2max) | Measured by cardiopulmonary exercise capacity (CPET) will be performed using a cycle ergometer test. Peak oxygen uptake measured in ml O2/kg/min. | From randomization (month 0) to 12 months | |
Secondary | Muscle strength, Handgrip strength | Hand-held dynamometer for measuring handgrip strength in kilograms. | From randomization (month 0) to 12 months | |
Secondary | Muscle strength, Knee-extension/flexion strength | Change in knee extension and flexion isokinetic strength (assessed by peak torque, Nm) and isometric strength (assessed by peak torque, Nm). | From randomization (month 0) to 12 months | |
Secondary | Physical performance, 6 minute walk test (6MWT) | Change in walking distance in meters. | From randomization (month 0) to 12 months | |
Secondary | Physical performance, 30 seconds sit to stand test | Change in counts of sit to stand. | From randomization (month 0) to 12 months | |
Secondary | The Short Physical Performance Battery | Changes in points. | From randomization (month 0) to 12 months | |
Secondary | Skeletal muscle mass | Thigh muscle mass by Magnetic Resonance Imaging (MRI) using Dixon method. | From randomization (month 0) to 12 months | |
Secondary | Skeletal muscle cross sectional area (CSA) of fibers | CSA of fibers by cryosection of skeletal muscle biopsy obtained from vastus lateralis muscle. | From randomization (month 0) to 12 months | |
Secondary | Skeletal muscle tissue fiber composition | Change in ratio between muscle fiber types (type I, IIa and IIb) assessed by immunohistochemistry. | From randomization (month 0) to 12 months | |
Secondary | Skeletal muscle tissue cellular composition | Change in muscle tissue cellular composition assessed by cell sorting | From randomization (month 0) to 12 months | |
Secondary | Skeletal muscle mitochondrial function | Change in muscle mitochondrial function assessed by high-resolution respirometry | From randomization (month 0) to 12 months | |
Secondary | Total lean body mass | Change in lean body mass (in grams) and total lean mass/height^2. | From randomization (month 0) to 12 months | |
Secondary | Total body fat percentage | Changes in body fat percentage. | From randomization (month 0) to 12 months | |
Secondary | Estimated visceral adipose tissue | Change in VAT index (kilogram-per-meters-squared index) and in mass (in grams). | From randomization (month 0) to 12 months | |
Secondary | Intramuscular and intermuscular fat content | Calculating thigh adipose tissue mass located between and within muscle fibers by MRI Dixon method. | From randomization (month 0) to 12 months | |
Secondary | Free fatty acids | Measured from blood samples. | From randomization (month 0) to 12 months | |
Secondary | Insulin resistance | Changes in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). | From randomization (month 0) to 12 months | |
Secondary | Markers of autophagy | Proteomics of skeletal muscle tissue and peripheral blood mononuclear cells (PBMCs). | From randomization (month 0) to 12 months | |
Secondary | Polyamine content in muscle biopsy | Measured with liquid chromatography mass spectrometry (LC-MS). | From randomization (month 0) to 12 months | |
Secondary | Polyamine content in blood | Plasma samples obtained from blood. Measured with liquid chromatography mass spectrometry (LC-MS). | From randomization (month 0) to 12 months | |
Secondary | Change in 24-hour ambulatory blood pressure measurements (24h ABPM) | Measured with the Spacelabs Healthcare 90217A device in an out-of-hospital setting. | From randomization (month 0) to 12 months | |
Secondary | Change in central blood pressure | Measured noninvasive with pulse wave analysis (PWA) using a SphygmoCor system. | From randomization (month 0) to 12 months | |
Secondary | Change in daily physical activity | Assessed by 14-day activity monitoring with an accelerometer (AX3, Axivity). | From randomization (month 0) to 12 months | |
Secondary | Change in cardiac extracellular volume fraction | Assessed using Cardiac Magnetic Resonance Imaging (CMR) with intravenous gadolinium-based agent. | From randomization (month 0) to 12 months | |
Secondary | Change in myocardial strain | Assessed using Cardiac Magnetic Resonance Imaging (CMR) with intravenous gadolinium-based agent. | From randomization (month 0) to 12 months | |
Secondary | Change in Carotid-femoral pulse wave velocity | Measured non-invasively through applanation tonometry using a SphygmoCor system. The unit of measure is m/s. | From randomization (month 0) to 12 months | |
Secondary | Change in Aortic pulse wave velocity | Magnetic resonance imaging (MRI) assessment. The unit of measure is m/s. | From randomization (month 0) to 12 months | |
Secondary | Change in general cognitive function and memory performance | Evaluated using the Montreal Cognitive Assessment (MoCA). It will be administered in a clinical setting using a tablet. MoCA score ranges from 0-30 and a score of 26 or higher is considered normal. | From randomization (month 0) to 12 months | |
Secondary | Change in specific domains of cognitive function | Evaluated using Cambridge Cognition (CANTAB) digital assessment software in a clinical setting using a tablet. The cognitive tests are MOT, RTI, SWM, DMS and PAL. These tests will objectively measure psychomotor speed, executive function and memory. | From randomization (month 0) to 12 months | |
Secondary | HeartQol | HeartQol measures health-related quality of life (HRQL) and is a disease-specific health status instrument for ischemic heart disease. It consists of 14 items and provides two subscales; a 10-item physical subscale and a 4-item emotional subscale, which are scored on a four-point Likert scale (0 to 3). Higher scores indicate a better HRQL. Measured as global, physical and emotional score. | From randomization (month 0) to 12 months | |
Secondary | Cytokines | Changes in cytokines are evaluated through the utilization of multiplex cytokine assays. Measured from plasma blood samples. | From randomization (month 0) to 12 months | |
Secondary | White blood cells | Changes in white blood cell differential count. | From randomization (month 0) to 12 months | |
Secondary | Immune cells | Changes in specific immune cell populations are measured using peripheral blood mononuclear cells (PBMCs) isolated from blood samples. | From randomization (month 0) to 12 months | |
Secondary | Vascular inflammatory markers | Measured from plasma blood samples with a multiplex assay. | From randomization (month 0) to 12 months | |
Secondary | Time to first occurrence of Composite cardiovascular endpoint: Cardiovascular death, heart failure hospitalizations, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization | Measured in months. | From randomization (month 0) to 12 months | |
Secondary | Days alive and out of hospital | Measured in months. | From randomization (month 0) to 12 months |
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