- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02588352
Evaluation of Salt Sensitivity in Young Adults
Studieoversigt
Detaljeret beskrivelse
Since salt sensitivity at an early age is associated with subsequent hypertension and an increase in mortality, intervention by lifestyle modification including the reduction of sodium intake could prevent subsequent increases in blood pressure and development of hypertension, cardiovascular disease and death. It would therefore be beneficial to have a simple method of identifying salt sensitive young adults so that risk factor modification can be achieved to prevent progression of the effects of hypertension on heart function.
This study is a longitudinal pilot study to identify characteristics of salt sensitive young adults so that this population of people can be identified early on and appropriate lifestyle modifications can be made to prevent the subsequent progression of hypertension and cardiovascular disease.
The study will be conducted at 2 visits separated by one week. At the first visit, eligible subjects will be asked to complete questionnaires regarding childhood and current sodium intake.Subjects will be asked about family history of hypertension and cardiovascular disease. Subjects will also undergo blood pressure measurement in both arm, and will provide a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times a day for one week, and then return to the study center for a repeat of the above measurements.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10016
- NYU Langone Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Young adults age 21-30
- Able and willing to provide written informed consent
Exclusion Criteria:
- Any cardiovascular or other chronic health problem
- Chronic medications besides oral contraceptive pills in women
- BMI>30kg/m2
- Blood pressure >140/90 mmHg
- Inability or unwillingness to adhere to study procedures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Healthy volunteers
Open label administration of salt tablets for one week
|
Subjects will be given salt tablets and instructed to take 4 grams of sale three times a day (total of 12 grams of salt/day) for one week
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Presence of salt sensitivity
Tidsramme: Visit 1 (One Week)
|
Defined as an increase in mean arterial blood pressure greater than 5 mmHg
|
Visit 1 (One Week)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in aldosterone level
Tidsramme: Baseline to Visit 2 (One Week)
|
change in serum aldosterone level
|
Baseline to Visit 2 (One Week)
|
Change in augmentation index (%)
Tidsramme: Baseline to Visit 2 (One Week)
|
Change in augmentation index determined by radial artery tonometry
|
Baseline to Visit 2 (One Week)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stuart Katz, MD, NYU Langone Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12-01669
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Salt tablet
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRekruttering
-
University of DelawareAfsluttetKardiovaskulær risikofaktorForenede Stater
-
Academia Sinica, TaiwanAfsluttet
-
Vanderbilt UniversityAfsluttet
-
Mulungushi UniversityRekruttering
-
Oxford Brookes UniversityAfsluttetSund og raskDet Forenede Kongerige
-
University of California, San FranciscoUniversity of Colorado, Denver; University of California, Davis; Post Graduate...Afsluttet
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); National Institutes...Rekruttering
-
Charite University, Berlin, GermanyAfsluttet