Clinical trial NCT01628302: Effect of Salt Restriction on Renin Activation
Official title: Investigation of Salt Restriction Effect on Renin Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension,plasma renin activity,salt consumption
Lead sponsor: Turkish Society of Hypertension and Renal Diseases
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in sodium levels in urine samples.
timeFrame: 3 weeks
measure: Change in plasma renin activity
timeFrame: For 3 times in 8 weeks
measure: Change in aldosterone level in blood samples
timeFrame: For 3 times in 8 weeks
measure: Change in potassium levels in urine samples.
timeFrame: 3 weeks
measure: Change in urea level in urine samples
timeFrame: 3 weeks
measure: Change in creatinin level in urine samples
timeFrame: 3 weeks
measure: Change in microalbumin level in urine samples
timeFrame: 3 weeks
measure: Change in aldosterone level in urine samples
timeFrame: For 3 times in 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University Faculty of Medicine Department of Nephrology
name: Mustafa Arici, Prof.
role: PRINCIPAL_INVESTIGATOR
References: