Clinical Research Directory

Cardiovascular-Kidney-Metabolic Syndrome Registry

The goal of this observational registry study is to learn about cardiovascular-kidney-metabolic syndrome, also called CKMS, among adults receiving care at tertiary care hospitals in India. CKMS describes the close relationship between excess body weight, metabolic conditions such as high blood pressure and diabetes, kidney disease, and cardiovascular disease. The main questions this study aims to answer are: * What proportion of participants are in each stage of CKMS when they enter the study? * How do participants' CKMS stage and related health factors change over 12 months? * How does participants' quality of life change over time? * What are the prescription practices for CKMS? Participants will: * Provide information about their general health, medical history, lifestyle, current medicines, family history, and quality of life. * Have measurements taken, including height, weight, waist circumference, and blood pressure. * Provide blood and urine samples for tests related to blood sugar, cholesterol, kidney function, inflammation, and heart health. * Undergo an electrocardiogram, also called an ECG, and a coronary artery calcium scan according to the study schedule. * Return for follow-up visits at 6 months and 12 months after joining the study. Participants will continue to receive their usual medical care as decided by their treating doctor. No experimental medicine or treatment will be provided as part of this study. This multi-centre registry will include approximately 2250 adults from five tertiary care hospitals in India. The information collected will help researchers understand the burden, progression, risk factors, quality of life, and treatment patterns of CKMS in India.

Food and Fitness With Medicine (FFWM)

Food and Fitness with Medicine (FFWM) is a 24-week randomized controlled trial (RCT) enrolling 200 post-menopausal women (PMW) with stage 2 cardio-kidney metabolic (CKM) syndrome and type-2 diabetes (T2D) within 6 weeks of initiating glucagon-like peptide-1 receptor agonist (GLP-1RAs) to: 1. Examine discontinuation rates of GLP-1RAs (primary outcome); 2. Compare change in American Heart Association (AHA) PREVENT scores (secondary outcome); and 3. Examine the effects of FFWM on biologic mechanisms responsive to weight loss and cardiovascular health (CVH) including dermal carotenoids, body composition and metabolite biomarkers.

Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Poor CKMH may lead to cardiovascular-kidney-metabolic syndrome (CKMS) - the five-stage framework introduced by The American Heart Association (AHA) which accounts for the critical overlap between cardiorenal syndrome and cardiometabolic disease. Evidence from randomized controlled trials shows glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT2is) may improve CKMH in individuals with Type 2 Diabetes (T2D) and/ or obesity. However, there is modest evidence suggesting differential effectiveness of GLP-1RA and SGLT2i drugs between males and females. The extent of these sex-based differences is currently unknown. In part, this may be due to underrepresentation of females in clinical trials. Exploring sex-based differences in GLP-1RA and SGLT2i treatment on CKMH outcomes is important to inform CKMS treatment and equity in CKMH. Robust secondary data sources present the opportunity to elucidate sex heterogeneity in GLP-1RA and SGLT2i treatment on CKMH outcomes. Using a target-trial emulation design, this study aims to observe differences in long-term CKMH outcomes between patients treated by GLP-1RA and SGLT2i medications versus those treated with active comparator medications, and whether there is an observed interaction between sex and treatment.