Clinical Research Directory

Effects of Quercetin on Cardiometabolic Outcomes

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Quercetin may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

The Role of Ectopic Fat and Heart Attack Risk in HIV

This study is designed to investigate differences between people living with HIV (PLWHIV) and general populations on how the body utilises and stores energy. This study uses magnetic resonance imaging (MRI) to measure fat around the body organs including the heart and liver. The fat around body organs, also known as visceral fat, is known to be associated with metabolic syndrome and a risk factor for developing heart attacks and strokes. MRI scans are used frequently in hospitals to diagnose a range of conditions. These scans use radio waves to measure protons in body tissues. The machines can reconstruct tissues using complex algorithms to form composite images of body structures. MRI scans do not use ionising radiation and there is no risk to undertaking an MRI in terms of radiation. We often use MRI scans to assess the hearts' structure and function. In addition, we can use specific MRI sequences to assess the integrity of heart muscle. Heart MRI is often considered the gold standard imaging technique to assess the heart and heart muscle disease. This sub-study will use multiple MRI sequences to assess the heart and the liver. We are aiming to investigate any changes in heart and liver fat. In addition, we will assess any changes in fat levels within the heart muscle cells whilst also assessing for any change in the way the heart is functioning. PLWHIV have roughly double the risk of heart attacks compared to general populations. Previous studies have demonstrated that this increased risk may arise from the way in which fat is stored and metabolised in the body. We hope this study will give insight into why HIV-positive individuals have increased risks of heart attacks and how reducing visceral fat may reduce risk. It may lead to further medicines or treatment strategies to reduce the risk of heart attacks in HIV-positive individuals.

The Mom and Infant Outcomes (MOMI) Study

The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

FEAST Perinatal Support Program Intervention

Latino individuals face an elevated risk of adverse health outcomes during pregnancy, impacting both the birthing parent and the baby with potential long-term chronic health conditions. While promoting a healthy diet during pregnancy is a promising strategy, interventions targeting dietary behaviors have yielded mixed results and lack widespread dissemination in communities in need. Collaborating with community-based organizations could enhance cultural relevance, build trust with Latino families, and improve program reach and effectiveness. Food Education Access Support Together (FEAST) is a community-based program that promotes healthy eating, well-being, and health equity for diverse, under-resourced urban populations in Los Angeles. The newly developed FEAST Perinatal Support Program (PSP) aims to support individuals through pregnancy and postpartum by providing dietary psychoeducation, skill-building, and social support, with an additional component of grocery gift cards to address food access barriers. This study proposes a pilot trial to assess the feasibility and preliminary efficacy of the FEAST PSP in enhancing dietary outcomes, overall health, and socio-cognitive precursors, in pregnant individuals. The study will enroll 40 pregnant adults in a single-arm study who will receive the core PSP with a $15 gift card for healthful fresh food (PSP+giftcard). Pre- and post-intervention assessments will include questionnaires, dietary recalls, physical measurements, and interviews to evaluate program perceptions. Specific aims include evaluating program feasibility and acceptability (i.e., reach, retention, and participant perceptions) and determining preliminary efficacy on changing socio-cognitive and behavioral aspects of diet, self-reported health, and cardiometabolic risk factors. The project aligns with goals of improving health outcomes in Latino families in Southern California and supports FEAST's strategic objectives for improving health and wellness of individuals during pregnancy and throughout the lifespan. The findings will inform program refinement and future NIH grants for rigorous evaluation of the FEAST PSP.

Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)

Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis. This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS. The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.

PDE3B in Metabolic Regulation

Phosphodiesterase 3B (PDE3B), an enzyme responsible for the degradation of cyclic AMP and GMP (two important second messengers used for intracellular signal transduction), has been associated with cardiometabolic outcomes. Results from animal studies indicate that abolishing PDE3B function may be associated with unfavourable metabolic profile; however, preliminary human studies suggest that heterozygous loss of function (LoF) variants in the PDE3B gene have been associated with cardiometabolic improvements. Therefore, the effect of PDE3B on human adipose tissue metabolic pathways remains poorly understood. Accordingly, the investigators propose to conduct a recall-by-genotype, case-control study in a group of people with LoF variants in the PDE3B gene and a matched group without the variant (wild type, WT) to determine differences on key metabolic features: 1) adipose tissue biology (i.e., mitochondrial function, adipocyte morphology, gene expression and in vivo lipolysis in the basal and/or the insulin-stimulated state); 2) systemic lipid and glucose metabolism using the hyperinsulinemic-euglycemic clamp procedure. The proposed investigations will elucidate the role of PDE3B on adipose tissue and systemic glucose and lipid metabolism in humans and whether modulating PDE3B activity constitutes a target for the prevention and treatment of cardiometabolic disease.

Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention

Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.

Spinal Cord Injury Model Systems (SCIMS) - Education Module

The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.

The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health

Recently a dietary recommendation of 400 - 600 mg/ day has been proposed for the reduced risk of developing cardiovascular disease. Dietary flavanols can be obtained from the intake of foods such as tea, cocoa, wine, berries and apples. Incorporating Chardonnay Marc (the skins and seeds of Chardonnay grapes) into the diet can be an additional source of dietary flavanols. Like other flavanol-rich foods, Chardonnay Marc provides fiber and polysaccharides that may benefit gut health. This study seeks pilot data on the impact of the daily incorporation of Chardonnay Marc powder into the diet on markers of gut and cardiometabolic health.

Telenutrition for Individuals With SCI

This study will provide nutrition counseling via FaceTime on an iPad to persons with traumatic spinal cord injury (SCI) who are overweight or obese and are at least one-year post-injury. Nutrition counseling may help participants to develop eating behaviors that match the participants' needs and help improve heart health. The purpose of this project is to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. This study will require 3 in person visits that are about 3 months apart. The total length of the study is about 6 months and includes 3 months of telenutrition counseling.

Impact of Yo-Yo Sleep on Cardiometabolic Health

The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).

LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering

Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk. There is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.

Effects of Green Tea on Cardiometabolic Outcomes

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Green tea may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

RE-inventing Strategies for Healthy Ageing; Recommendations and Tools

The goal of the RESTART RCT is to examine whether a complex lifestyle intervention, coordinated with municipal and non-government organizations (NGO), can establish and preserve improvements in risk factors and functional capacity among older adults at high risk of cardiometabolic disease. The main objectives to investigate are whether a complex lifestyle intervention, compared to an active control group, will at 24 months have: 1. Produced a clinically relevant increase in cardiorespiratory fitness (primary endpoint) 2. Increased muscle strength, physical activity and reduced adiposity 3. Improved body composition, health-related quality of life and cognitive function All participants (Control and Intervention Groups) are provided with wrist-worn activity trackers at baseline and access to national recommendations on physical activity. The intervention group additionally advances through a comprehensive lifestyle program including high-intensity aerobic and strength exercise, dietary and behavioral counselling. Intervention participants are gradually transitioned into exercise activities organized by Tromsø Municipaity and local NGO:s. Testing of outcomes are performed at baseline, 6, 12 and 24 months. Primary endpoint (VO2max) is assessed at 24 months.

Circadian Intervention to Improve Cardiometabolic Health

The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Hyperpolarized MR Imaging with Carbon-13 Pyruvate in the Human Body

Positron emission tomography with 18F fluorodeoxyglucose (FDG) is the conventional imaging technique to provide information regarding tissue glucose uptake and has been highly clinically successful. However, it cannot assess downstream metabolism, which may be useful in the diagnosis and assessment of treatment response in a variety of diseases. Patients will also be exposed to ionizing radiation, the amount of exposure can vary depending on the dose of tracer administered, frequency of scans and duration of each scan. Carbon-13 (13C) magnetic resonance imaging (MRI) is particularly attractive for metabolic imaging because carbon serves as the backbone of nearly all organic molecules in the body. With this technique, the polarization increases to approximately 30%-40%, an increase of over 10,000 to 100,000-fold, thereby dramatically increasing the MRI signal . Whilst the role of 13C imaging has been demonstrated in many sites around the world, we aim to demonstrate the feasibility and application of 13C hyperpolarized imaging in healthy Singapore residents and patients with cardiovascular and/or cardiometabolic diseases.

Effects of Different Dietary Interventions on Abdominal Fat Components, Quadriceps Muscles and Cardiometabolic Parameters

The study aims to evaluate the impact of different dietary interventions on body composition (abdominal fat components and quadriceps muscles) and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly for the first 6 months to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines, and monitor anthropometric measurements, abdominal adipose tissue, quadriceps muscles, and biochemical parameters. A reassessment will be performed at 12 months to analyze weight regain, analysis of anthropometric measurements, abdominal adipose tissue, quadriceps musculature and biochemical parameters. The evaluation of VAT, subcutaneous adipose tissue (SAT) and quadriceps musculature by ultrasound will be performed at baseline and after 3, 6 and 12 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 3, 6 and 12 months on weight, abdominal fat deposits, quadriceps muscles and cardiometabolic parameters.

Interval Training and Cardio-metabolic Health in Overweight/Obese Girls

The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls.

iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease.

Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study

POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations.

REgiStry-based Cardiovascular qUality improvEment Research

The goal of this registry-based observational study is to establish a comprehensive management plan, which focus on medical therapy, cardiac rehabilitation and active post-market surveillance of medical devices, in patients with cardiovascular diseases (CVD). Patients with CVD mainly refers to four groups of patients：1) post-percutaneous coronary intervention (post-PCI) patients; 2) patients with heart failure (HF); 3) patients with cardiometabolic diseases (CMD); 4) patients with structural heart disease (SHD), and the detailed definition of each group can be found in "Eligibility" section. The main questions this study aims to answer are: * the effectiveness of exercise-based cardiac rehabilitation in improving cardiac function, reducing CVD recurrence and mortality, and promoting quality of life for patients with CVD; * the feasibility of registry-based active post-market surveillance of high-risk medical devices used in cardiovascular surgeries, such as PCI, heart valve replacement, and cardiac resynchronization therapy (CRT); * the utilization of multiomics datasets to identify and dissect cardiovascular heterogeneity in both healthy and diseased populations and to guide precision medicine in patients with CVD; * the analysis and evaluation of the prescription patterns and drug response in patients with CVD.