Renal Metabolism in Salt-sensitive Human Blood Pressure

NCT05369416 | Active Not Recruiting

• 1 other identifier: PRO00037003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

hypertension; high blood pressure; salt

Outcome Measures

Primary Outcomes (1)

• Changes in renal regional tissue oxygenation in response to salt intake and salt sensitivity

  70 subjects (\~50% women, \~50% AA) will be recruited and salt sensitivity will be determined (defined as ≥8 mmHg decrease in systolic BP on a low Na+ diet). BOLD-MRI and MRI with arterial spin labeling (MRI-ASL) will be performed to assess renal regional tissue oxygenation and perfusion at baseline and after high and low Na+ diets.

  6 weeks

Secondary Outcomes (1)

• Changes in renal metabolites in response to a high sodium diet among individuals who are salt-sensitive versus insensitive

  6 weeks

Study Arms (2)

Low sodium diet

ACTIVE COMPARATOR

-Subjects will be randomized to start a low sodium diet (1200 mg/day) for two weeks (this will be followed by a high sodium diet - crossover design)

Other: Low sodium diet

high sodium diet

ACTIVE COMPARATOR

-Subjects will be randomized to start a high sodium diet (4200 mg/day) for two weeks (this will be followed by a low sodium diet - crossover design)

Other: high sodium diet

Interventions

Low sodium diet OTHER

Subjects will be started on a low sodium (food will be provided) for two weeks.

Low sodium diet

high sodium diet OTHER

Subjects will be started on high sodium diet (regular diet supplemented with salt tablets to reach a daily intake of \> 4200 mg/Day) for two weeks.

high sodium diet

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin /Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Srividya Kidambi, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: We are using a crossover design of low-sodium and high-sodium diets of 2 week duration each. Both diets consecutively given to each subject recruited in the study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: November 1, 2021
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): January 30, 2030
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)