Covid 19 Research using Clinical Trials (Home Page)
Report for D024821: Metabolic Syndrome NIH
(Synonyms: Metabolic S, Metabolic Syn, Metabolic Syndrome)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
There are 2 clinical trials
Clinical Trials
1 Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome
Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.
NCT03170375 Heart Failure Behavioral: Performance of WHEELS-I in promoting DASH/SRD adoption Behavioral: Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors MeSH:Heart Failure Metabolic Syndrome
HPO:Congestive heart failure Left ventricular dysfunction Right ventricular failure
Primary Outcomes
Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 1 of study, change from baseline at the end of week 2 and week 4
Description: Left ventricular mass indexed to height
Measure: Left ventricular mass index Time: Phase 2 of study, change from baseline to 6 months
Secondary Outcomes
Description: Ventricular stiffness k, by Parametrized Diastolic Formalism analysis
Measure: Ventricular stiffness Time: Phase 1 of study, change from baseline at the end of week 2 and week 4
Description: Global longitudinal left ventricular strain, a sensitive measure of ventricular systolic function
Measure: Global longitudinal left ventricular strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4
Description: Global left atrial strain, a novel measure of atrial function
Measure: Global left atrial strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4
Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 2 of study, change from baseline to 6 months
Description: Left atrial volume by 3D echocardiography
Measure: Left atrial volume Time: Phase 2 of study, change from baseline to 6 months
Other Outcomes
Description: Change in 24-hour mean of >= 8 mmHg will define the salt-sensitive blood pressure phenotype
Measure: Salt-sensitivity phenotype Time: Phase 1 of study, change from baseline at the end of week 2 and week 4
Description: Measure of dietary sodium intake
Measure: 24-hour urinary sodium excretion Time: Phase 2 of study, change from baseline to 6 months
Description: Sodium-restricted DASH diet score on Food Frequency Questionnaire, measured by complete or partial adherence to 9 dietary domains
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, change from baseline to 6 months
Description: Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, months 1 and 6
2 A Virtual Nutritional Education Delivered Through a Hospital Teaching Kitchen : a Proof-of-concept Study
Primary Outcomes
Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Left ventricular mass indexed to height
Measure: Left ventricular mass index Time: Phase 2 of study, change from baseline to 6 monthsSecondary Outcomes
Description: Ventricular stiffness k, by Parametrized Diastolic Formalism analysis
Measure: Ventricular stiffness Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Global longitudinal left ventricular strain, a sensitive measure of ventricular systolic function
Measure: Global longitudinal left ventricular strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Global left atrial strain, a novel measure of atrial function
Measure: Global left atrial strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 2 of study, change from baseline to 6 monthsDescription: Left atrial volume by 3D echocardiography
Measure: Left atrial volume Time: Phase 2 of study, change from baseline to 6 monthsOther Outcomes
Description: Change in 24-hour mean of >= 8 mmHg will define the salt-sensitive blood pressure phenotype
Measure: Salt-sensitivity phenotype Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Measure of dietary sodium intake
Measure: 24-hour urinary sodium excretion Time: Phase 2 of study, change from baseline to 6 monthsDescription: Sodium-restricted DASH diet score on Food Frequency Questionnaire, measured by complete or partial adherence to 9 dietary domains
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, change from baseline to 6 monthsDescription: Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, months 1 and 6A novel way of delivering nutritional education is through experiential learning in a teaching kitchen setting. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had improved cardiac health. Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity and its consequences. This includes a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established three-pronged approach places our institution in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population. Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV-2, the investigators are proposing a study where patients can benefit from nutritional education virtually. Patients with food insecurity and metabolic syndrome who utilize the food pantry will be invited to an educational program conducted on zoom. The program will be run by a registered dietician and chef who will deliver education virtually. Data will be collected using surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this program improves cardiac health in patients.
NCT04509206 Cardiac Health Metabolic Syndrome Behavioral: Nutritional education MeSH:Metabolic Syndrome
Primary Outcomes
Description: based on number of people invited to participate, number recruited and consented and number attended
Measure: recruitment rates Time: 12 monthsDescription: based on attendance at each virtual educational session
Measure: retention rates Time: 12 monthsDescription: information will be obtained through qualitative interviews
Measure: facilitators for nutritional education Time: 12 monthsDescription: information will be obtained through qualitative interviews
Measure: barriers to nutritional education Time: 12 monthsSecondary Outcomes
Description: through qualitative interview
Measure: knowledge of healthy foods Time: 12 monthsDescription: Baseline BP will be extracted from medical chart. Subjects will be provided with a home BP cuff. BP measurements performed by the patient will be recorded on the BP app. The 6 month follow BP will be extracted from the medical chart if available.
Measure: change in blood pressure (BP) Time: baseline, up to 6 monthsDescription: Baseline blood glucose will be extracted from medical chart. Subjects will use their own glucometer to measuture their blood glucose. glucose measurements performed by the patient will be recorded on the glucometer. The 6 month follow blood glucose will be extracted from the medical chart if available.
Measure: change in blood glucose Time: baseline, up to 6 monthsDescription: Baseline will be extracted from the chart and 6 month will be extracted from the chart if available
Measure: change in hemoglobin A1c Time: baseline, 6 monthsDescription: Baseline weight will be extracted from medical chart. Subjects will be provided with a home scale. weight measurements performed by the patient will be recorded on the scale app. The 6 month follow weight will be extracted from the medical chart if available.
Measure: change in weight Time: baseline, up to 6 months