Renal Metabolism in Salt-sensitive Human Blood Pressure

NCT ID: NCT05369416

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2030-01-30

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.

Detailed 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.

Conditions

Hypertension

Keywords

hypertension; high blood pressure; salt

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low sodium diet

-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)

Group Type: ACTIVE_COMPARATOR

Low sodium diet

Intervention Type: OTHER

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

high sodium diet

-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)

Group Type: ACTIVE_COMPARATOR

high sodium diet

Intervention Type: 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.

Interventions

Low sodium diet

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

Intervention Type: OTHER

high sodium diet

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Srividya Kidambi, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Srividya Kidambi, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin /Froedtert Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00037003

Identifier Type: -

Identifier Source: org_study_id