Renal Metabolism in Salt-sensitive Human Blood Pressure

  • STATUS
    Recruiting
  • End date
    Jan 30, 2030
  • participants needed
    70
  • sponsor
    Medical College of Wisconsin
Updated on 4 June 2022
hypertension
low sodium diet
raised blood pressure
diet, sodium-restricted

Summary

Salt sensitive hypertension is a significant health problem worldwide and a primary modifiable risk factor for renal, cardiovascular, and cerebrovascular diseases. Yet, the underlying mechanisms remain poorly understood.

The proposed study determines how renal oxygenation and substrate metabolism differs between individuals with and without salt sensitivity, with the ultimate goal of identifying mechanisms, diagnostic criteria, and treatment strategies for salt sensitive hypertension.

Description

Seventy subjects will be enrolled and randomized to start either a low sodium diet (1200 mg/day) or high sodium diet (>4200 mg/day) for two weeks. After completion of two weeks, subjects will be switched to the 'other' diet for two weeks after a one-week wash-out. During the screening visit, subject's daily sodium intake will be assessed using multiple methods and further dietary information will be collected to prepare customized low sodium meals. During low sodium diet period, subjects will be supplied with food and will be asked to keep food logs. At the end of two-week period, the study activities described below will be carried out including BOLD MRI imaging along with imaging techniques to assess renal oxygenation levels and perfusion. During high sodium diet period, subjects will be either supplemented with sodium chloride tablets or high sodium foods to achieve a daily sodium intake above 4200 mg/day. If subjects already consume over 4200 mg/day of sodium, no changes will be made to their diet and assessment of oxygenation (BOLD MRI) and perfusion will take place after two weeks.

At the end of high sodium diet, 18 subjects will have renal vein sampling performed (this will be equally divided between salt-sensitive and salt-insensitive subjects and per subject preference as all may not want to have renal vein sampling). Subjects will be classified into salt sensitive or insensitive at the end of low sodium diet period based on BP response for further data analyses.

Details
Condition Hypertension
Treatment Low sodium diet, High Sodium Diet
Clinical Study IdentifierNCT05369416
SponsorMedical College of Wisconsin
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

English speaking subjects
With a spectrum of BPs, ranging from those with Elevated BP through Stage 1 HTN, as defined by the 2017 ACC/AHA HTN guidelines

Exclusion Criteria

Non-English speakers
BP ≤120/80 & ≥ 140/90 mmHg
H/o diabetes, congestive heart failure, cirrhosis of the liver, hypokalemia & other
electrolyte disturbances
H/o kidney disease
Use of glucocorticoids
Pregnant or nursing mothers
Presence of bleeding disorders
Use of anti-platelet and anticoagulant agents such as clopidogrel, aspirin, dabigatran, rivaroxaban etc
Daily sodium intake ≥ 6000 mg/day
Presence of pacemaker or other metallic implants
Allergy to iodinated contrast
Allergy to shellfish
Claustrophobia
Clear my responses

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