[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366758":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":78,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":40,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":40,"enrollmentInfo":94,"targetDuration":40,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":109,"overallStatus":62,"whyStopped":40,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacubitril\u002FValsartan","EXPERIMENTAL","We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.",[13,14,15,16],"Drug: Sacubitril, Valsartan 97-103 mg Oral Tablet","Other: Intravenous Glucose Tolerance Test","Dietary Supplement: Standardized Meals","Other: Exercise capacity VO2 maximum determination",{"label":18,"type":19,"description":11,"interventionNames":20},"Valsartan","ACTIVE_COMPARATOR",[21,14,15,16],"Drug: Valsartan 160 mg",[23,30,36,41,46],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Sacubitril, Valsartan 97-103 mg Oral Tablet","The subject will be randomized, in a double-blind manner to sacubitril\u002Fvalsartan 97\u002F103 mg twice daily for a period of 12 weeks.",[9],[29],"Sacubitril\u002FValsartan arm",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Valsartan 160 mg","The subject will be randomized, in a double-blind manner to valsartan 160 mg twice daily for a period of 12 weeks.",[18],[35],"Valsartan arm",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Intravenous Glucose Tolerance Test","An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.",[9,18],null,{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":40},"DIETARY_SUPPLEMENT","Standardized Meals","Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.",[9,18],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":40},"Exercise capacity VO2 maximum determination","Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.",[9,18],[51],{"name":52,"affiliation":5,"role":53},"Pankaj Arora, MD, FAHA","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":40,"email":59},"Nehal Vekariya, MS","CONTACT","205-934-7173","nvekariya@uabmc.edu",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-86.80249,33.52066,{"lat":72,"lon":71},[75,76],{"name":56,"role":57,"phone":58,"phoneExt":40,"email":59},{"name":77,"role":53,"phone":40,"phoneExt":40,"email":40},"Pankaj Arora, MD",{"type":53,"investigatorFullName":77,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Associate Professor, Division of Cardiovascular Disease, Department of Medicine",[81],{"name":82,"class":83},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100366758","phase-2-nautical-effect-of-natriuretic-peptide-augmentation-on-cardiometabolic-health-in-black-individuals-100366758",false,"NCT04055428","NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals","The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)","Inclusion Criteria:\n\n* Adults: Age more than or equal to 18 years of age\n* Self-identified race\u002Fethnicity as African-American or Black\n* Blood pressure: 120-160\u002F80-100 mmHg\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)\n* Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)\n* BP more than 160\u002F100 mmHg\n* BMI \\>45 kg\u002Fm2\n* History of diabetes or fasting plasma glucose \\>=126 mg\u002FdL or HbA1C\\>=6.5%\n* History of angioedema\n* Current or past (\\\u003C12 months) history of smoking\n* Estimated GFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2; albumin-creatinine ratio ≥30 mg\u002Fg\n* Hepatic Transaminase (AST and ALT) levels \\>3x the upper limit of normal\n* Significant psychiatric illness or seizure disorder\n* More than 2 Alcoholic drinks daily\n* Anemia (men, Hct \\\u003C 38%, Hb\\\u003C13 g\u002FdL; women, Hct \\\u003C36%, Hb \\\u003C12 g\u002FdL)\n* Inability to exercise on a treadmill",true,"ALL","18 Years",{"count":95,"type":96},200,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril\u002Fvalsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity \\& energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population.",[102,103,104,105,106,107,108],"Diabetes Mellitus","Cardiovascular Diseases","Insulin Sensitivity\u002FResistance","Metabolic Disease","Natriuretic Peptides","Metabolism","Energy Expenditure",[106,110,111,108],"Diabetes","Insulin Sensitivity","2025-07-01",{"date":114,"type":115},"2025-07-03","ACTUAL",{"date":117,"type":115},"2020-08-15",{"date":119,"type":96},"2027-05-31",{"name":5,"class":6},1]