Clinical Trials Logo

Clinical Trial Summary

Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study


Clinical Trial Description

The prevalence of non-communicable disease (NCD including cardiovascular disease (CVD), diabetes mellitus (DM),hypertension(HT) and chronic kidney disease(CKD) continues to rise all over the world and lead to global crisis.The world Health Organization (WHO) shows that more than 50% of the burden of diseases arise from NCD and 30% is attributed to CVD[1] .In Thailand,the prevalence of high blood pressure in population age > 15 is increasing in the past 10 years .In 2022 the HT prevalence was 21.4 and the admission rate of CVD increased from 109.4 to 793.3 per 100,000 population [2]. Cumulating evidence highlights that higher sodium consumption contributes to higher BP [3], thus increasing the risk of cardiovascular disease (CVD) [4,5]. According to the World Health Organization, the restriction of sodium intake to less than 2.3 g/day of sodium corresponding to 5.8 g of salt (or 100 mmol) is one of the most cost-effective measures to improve public health [6]. In particular, in a large cohort study in over 100,000 patients from 18 countries the role of higher salt consumption was associated with increased BP levels [7], and poor CV outcomes [8].In one meta-analysis ,reduce salt intake to 1,800 mg per day will help reduce blood pressure by 2/1 mmHg in non-hypertensive cohorts and 5/2.7 mmHg in hypertensive patients [4].In fact, even minor sodium restriction for only 700-800 mmol/day was associated with reduction of CVD and mortality risks for 20 and 5-7% respectively. A long-standing line of evidence also shows beneficial effects of salt reduction in patients with chronic kidney disease (CKD) as well as in healthy people [9,10]. A recent review of the evidence for the relationship between salt intake and CKD progression concluded there is consistent evidence to suggest that dietary salt intake is linked with albuminuria and tissue injury [9] [11]. High salt intake is closely associated with the progression of CKD. When the urine sodium-to-creatinine ratio increases by 100 mmol/L, the risk of CKD developing into end-stage renal disease (ESRD) increases by 1.61 times [12,13]. High salt intake leads to renal impairment in various ways, including increasing transforming growth factor (TGF)-β1 production and enhancing oxidative stress and inflammatory response kidney [14-16]. The Lowsalt CKD trial trials had shown that in patients with CKD, salt reduction will have additional beneficial effects on renal effects, reduction of proteinuria,independent of blood pressure lowering effect. reported that salt reduction helped control blood pressure,reduce proteinuria [17] .However,the follow up time was too short. Meta-analysis data from Garofalo et al [18] indicates that low sodium intake ( 4.4 gm/day) in 738 CKD patients from 9 studies significantly reduce systolic blood pressure by 4.9 mmHg (95%CI 6.8/31 mmHg, p <0.001) .The diastolic blood pressure also reduce by 2 mmHg (95%CI 6.8/3.1 mmHg, P<0.001) .In CRIC study[19] which followed a cohort of 3,757 CKD patients for nearly 7 years,the authors found that the high urine sodium group (UNaV > 195 mmoL/day) significantly increased risk for CKD progression and CVD risk. These data support the evidence that reducing dietary sodium can reduce cardiovascular risk and rate of CKD progression. However, restriction in dietary sodium intake also activates the renin-angiotensin -aldosterone system (RAAS) and sympathetic nervous system[20,21].Low dietary sodium has been reported to be associated with insulin resistance [22]. To date, the connection between sodium intake and CKD progression provided inconsistent results [23]. Although several studies have shown that high dietary sodium intake increases the risk of CKD development or progression [24-26], some results failed to find significant connections to renal outcome [27-30]. In addition, there have also been reports that lower 24-hour urine sodium excretion is associated with higher risk of death and ESRD in individuals with type 1 and type 2 diabetes with overt proteinuria [30,31]. Whether an intensive short-term dietary sodium restricted intervention will have beneficial effects on the glomerular filtration rate (GFR) and on the susceptibility to develop proteinuria, both measures of kidney function will be the objective of this study ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05716386
Study type Interventional
Source Bangkok Metropolitan Administration Medical College and Vajira Hospital
Contact
Status Completed
Phase N/A
Start date February 28, 2023
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A