Gender Differences in Renal Functioning and Disease

NCT04085094 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2023-09-13

No results posted yet for this study

Summary

The purpose of the GenderBOLD study is to shed light on the mechanisms responsible for women's lower susceptibility to developing and progressing chronic renal disease, using modern imaging techniques, and applying different diets. The investigators postulate that oxygenation and renal perfusion are better conserved and change less in women than in men in different dietary situations (high salt-low salt), possibly because they are able to store excess salt in their skin and muscles. The investigators postulate that these differences are independent of their menstrual cycle. Finally, the investigators will analyze the renal functional reserve and changes in renal perfusion through an oral protein load and after sublingual nitroglycerin to assess whether potential différences exist between genders.

Conditions

  • Chronic Renal Failure
  • Healthy Controls

Interventions

DIETARY_SUPPLEMENT

high-salt diet (V1) and low salt diet (V2)

Before the first visit, the participant will follow a five-day high salt diet (addition of 6g/day of salt to their regular diet followed at home). Before the second visit (V2), the participant will follow for five days a low-salt diet, according to dietary instructions followed provided during the screening visit.

DIAGNOSTIC_TEST

Contrast-enhanced ultrasound (CEUS)

Renal ultrasound with use of a contrast product (SonoVue®), perfusion rate 0.015ml/kg/min. Four destruction-reperfusion sequences are performed in order to measure the Perfusion Index (PI) of the renal cortex.

DIAGNOSTIC_TEST

functional MRI

Measurement of renal oxygenation with the Blood Oxygenation Level Dependant-MRI technique (BOLD-MRI) on Siemens Prisma 3T scanner before and 15minutes after 0.03mg/kg of IV furosemide. Assessment of the amount of salt stored in the skin and muscles with the 23Na MRI technique.

OTHER

Pilocarpine test

Assessment of sweat salt and potassium concentrations in healthy volunteers according to slat intake. Two electrodes are placed on the forearm. The electric current between the two electrodes will induce perspiration which will be collected with the Macroduct system.

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER
  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Menno Pruijm, PD MD · CHUV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2019-12-02
Completion
2019-12-02

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04085094 on ClinicalTrials.gov