Chronic Renal Failure Clinical Trial
— GenderBOLDOfficial title:
Gender Differences in Renal Disease Progression: an Analysis of Potential Mechanisms Using Modern Radiological Techniques
NCT number | NCT04085094 |
Other study ID # | 2016-01971 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2017 |
Est. completion date | December 2, 2019 |
Verified date | September 2023 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | December 2, 2019 |
Est. primary completion date | December 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion/exclusion Criteria: Inclusion criteria for healthy pre-menopausal women: - Age = 18 years old and <50 years old. - No drugs (psychoactive substances used for non-medical purposes) /medicine. - Blood pressure <135/85mmHg. - Renal function (eGFR >90ml/min/1.73m2) and absence of albuminuria. - Regular menstrual cycle. - No pregnancy. - Understanding and signature of the informed consent. Inclusion criteria for pre-menopausal women with a chronic renal failure: - Age = 18 years old and <50 years old. - Possibility to stop the treatment during the day of the study. - Reduced renal function (eGFR 15-60 ml/min/1.73m2) or eGFR 60-90 ml/min/1.73m2 with the presence of albuminuria >300 mg/j. - Understanding and signature of the informed consent. Inclusion criteria for post-menopausal women: - Age = 50 years old. - Absence of menstruation. - No drugs consumption. - No medicine, or possibility to stop it two days before the study. - Blood pressure <135/85mmHg. - Renal function (eGFR >90ml/min/1.73m2) and absence of albuminuria. - Understanding and signature of the informed consent. Inclusion criteria for men: - Age = 18 years old, but matched with the age of pre- aor post-menopausal women - No drugs consumption. - No medicine, or possibility to stop it two days before the study. - Blood pressure <135/85mmHg. - Renal function (eGFR >90ml/min/1.73m2) and absence of albuminuria. - Understanding and signature of the informed consent. Exclusion criteria for all: - Contra-indication for Magnetic Resonance Imaging (Pacemaker, implanted metallic device, claustrophobia,..) - Known allergy to one of the study compounds (furosemide, Sonovue). Exclusion criteria for persons with chronic renal failure: - Autosomal dominant polycystic kidney disease. - Ingestion of corticosteroids or other immunosuppressants. - Volume overload or heart failure. - eGFR < 15ml/min/1.73m2 or dialysis. Exclusion criteria for men and women receiving sublingual nitroglycerin: - Hypersensitivity to nitrous derivatives or to one of the excipients present in the composition. - History of heart disease (ischemic heart disease, valve and/or rhythmic). - Low blood pressure (systolic blood pressure <100mmHg) |
Country | Name | City | State |
---|---|---|---|
Switzerland | CHUV, nephrology service | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois | University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in renal microperfusion according to dietary salt intake in healthy and CKD | Renal perfusion is measured with the contrast-enhanced ultrasound (CEUS) | 1 month (5 days high salt- two weeks wash out- 5 days low salt) | |
Primary | Change in renal oxygenation after salty/unsalted diets in women compared to men | Renal oxygenation is measured by Blood Oxygen Level Dependent (BOLD-IRM) | 1 month | |
Primary | Change in skin and muscle storage of sodium according to salt intake | Changes in cutaneous and muscle sodium storage measured by 23Na-MRI | 1 month | |
Primary | Change in renal perfusion measured with CEUS after SL nitroglycerine | Renal perfusion is measured with the contrast-enhanced ultrasound (CEUS) | before-5 minutes after NTG |
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