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Effect of Salt Restriction on Renin Activation

Investigation of Salt Restriction Effect on Renin Activation

The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects.

Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The present study is carried out with the subjects who are chosen among the nursing home residents in İzmir. The subjects were randomized to 2 groups and while one of these groups had low salt diet (50mmol), the other group had normal salt diet (250mmol) for 3 weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks. According to crossover nature of the study, the group that had normal salt diet at the first 3 weeks of study had low salt diet at the last 3 weeks of the study. The other group that had low salt diet had the normal salt diet at the last 3 week of the study.

At the beginning of the study, information such as demographic, family story, medical story, diet habits, concomitant medication and physical measurements (height, weight and waist circumference) were received from the subjects.

24 hour blood pressure of the subjects is measured for four times, before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. The subjects were asked for collecting 24-h urine in the same days of blood pressure measurement. Sodium, potassium, urea, creatinin and microalbumin measurements were measured in the collected urine. Blood samples were collected for three times, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. Plasma renin activity and aldosterone levels were measured in the blood samples collected. Aldosterone level was measured in the 24-hour urine in mentioned days.

Studietype

Intervensjonell

Registrering (Faktiske)

28

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who are 50 years and older
  • Subjects whose systolic blood pressure is ≥ 140 mmHg
  • Subjects whose diastolic blood pressure is ≥ 90 mmHg
  • Subjects who is normal weighted defined as body mass index < 25 or who is obese defined as body mass index > 30
  • Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
  • Informed about the study and consented to include the study

Exclusion Criteria:

  • Known heart failure
  • Known renal failure
  • Known chronic liver disease
  • Antihypertensive drug use
  • nonsteroidal anti inflammatory (NSAI) drug use

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Normal salt diet
The group had normal salt diet (250mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had low salt diet (50mmol) at the last 3 weeks of the study.
Eksperimentell: Low salt diet
The group had low salt diet (50mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had normal salt diet at the last 3 weeks of the study.
Low salt diet (50mmol)for three weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
Tidsramme: 3 weeks
24-hour ambulatory blood pressure was measured before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
3 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in sodium levels in urine samples.
Tidsramme: 3 weeks
Sodium was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
3 weeks
Change in plasma renin activity
Tidsramme: For 3 times in 8 weeks
Plasma renin activity level was measured in the blood samples collected, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
For 3 times in 8 weeks
Change in aldosterone level in blood samples
Tidsramme: For 3 times in 8 weeks
Aldosterone levels was measured in the blood samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
For 3 times in 8 weeks
Change in potassium levels in urine samples.
Tidsramme: 3 weeks
Potassium was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
3 weeks
Change in urea level in urine samples
Tidsramme: 3 weeks
Urea was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet
3 weeks
Change in creatinin level in urine samples
Tidsramme: 3 weeks
Creatinin was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
3 weeks
Change in microalbumin level in urine samples
Tidsramme: 3 weeks
Microalbumin was measured in 24-hour collected urine samples before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet
3 weeks
Change in aldosterone level in urine samples
Tidsramme: For 3 times in 8 weeks
Aldosterone levels was measured in in the 24-hour urine samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
For 3 times in 8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mustafa Arici, Prof., Hacettepe University Faculty of Medicine Department of Nephrology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2011

Primær fullføring (Faktiske)

1. juli 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

13. juni 2012

Først innsendt som oppfylte QC-kriteriene

22. juni 2012

Først lagt ut (Anslag)

26. juni 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. juni 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juni 2012

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HT-Salt

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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