Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Git… (NCT02297048) | Clinical Trial Compass
CompletedPhase 4
Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Gitelman Syndrome)
France26 participantsStarted 2014-07
Plain-language summary
Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the urines. The investigators wonder whether progesterone or other adrenal hormon play the same role. The investigators will investigate surrenal hormone production in healthy subjects under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a renal loss of potassium.
Who can participate
Age range18 Years – 75 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for healthy subjects:
* Caucasian male subject
* 18-35 yrs-old
* BMI between 18 and 30 Kg/m2
* Normal biological pattern (sodium, potassium, eGFR \>60mL/min/1.73 m2, SGOT and SGPT \< 2.5 normal value)
* Non smoker subjects or less than 5 cigarettes a day
* No drug abuse
* No active viral B or C hepatitis, no positive HIV serology
* No treatment except paracetamol
* Normal EKG
* Inform consent given
* Affiliation to French Medicare assurance
Inclusion Criteria for patients :
* 18-75 Years old subjects
* genetically proven Gitelman syndrome
* Normal EKG
* Inform consent given
* Affiliation to French Medicare assurance
Non inclusion Criteria for healthy subjects:
* History of cardiac arrythmia or abnormal EKG
* Recent or chronic diarrhea
* Spontaneous low potassium intakes
* Biological abnormality : SGOT or SGPT \> 2.5 N, fasting hyperglycemia (\> 6.5 mmol/l, anemia (hemoglobin\< 12g/dL)
* Single or functionally solitary kidney
* Any severe allergies, or allergic history to any drug.
* Predicted Difficulty monitoring and compliance.
* Blood donation for less than 2 months.
* Persons directly involved in the implementation of the Protocol.
* Person in exclusion period in biomedical research.
* Protected Person (person under guardianship, deprived of liberty, ...).
* Taking medication in the previous 7 days (except paracetamol).
* Chronic adrenal insufficiency.
* Known allergy to any of the excipients of the RU 486 (colloidal anhydrous silica, maize starch,…
What they're measuring
1
Effect of potassium depletion on plasma progesterone (Change from Baseline of progesterone)
Timeframe: Day 1 and Day 8 of placebo period of treatment (healthy subjects) or once (Gitelman patients)