Status:
COMPLETED
Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Gitelman Syndrome)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gitelman Syndrome
Potassium Depletion
Eligibility:
MALE
18-75 years
Phase:
PHASE4
Brief 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 investiga...
Detailed Description
The investigators will study the adaptation of steroidogenesis to potassium depletion in healthy volunteer, and the role of progesterone in renal adaptation to potassium depletion. Practically, health...
Eligibility Criteria
Inclusion
- 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, povidone, microcrystalline cellulose, magnesium stearate).
- Severe asthma not controlled by treatment.
- Porphyria hereditary.
- Non inclusion Criteria for Gitelman patients:
- People that did not give their consent or unable to understand the protocol.
- Anemia (Hg \<10 g / dL).
- Clinically significant abnormality on the EKG.
- Any severe allergies, or allergic history to any drug.
- Treatment with corticosteroids.
- Patient in exclusion period in biomedical research.
- Protected Person (patient trust, deprived of liberty, ...)
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02297048
Start Date
July 1 2014
End Date
September 1 2015
Last Update
October 1 2015
Active Locations (1)
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1
European George Pompidou Hospital
Paris, France, 75015