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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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

28

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in sodium levels in urine samples.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2011

Completamento primario (Effettivo)

1 luglio 2011

Completamento dello studio (Effettivo)

1 luglio 2011

Date di iscrizione allo studio

Primo inviato

13 giugno 2012

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2012

Primo Inserito (Stima)

26 giugno 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 giugno 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 giugno 2012

Ultimo verificato

1 agosto 2011

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HT-Salt

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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