Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Gitelman Syndrome)

Phase 4

Completed

• Conditions: Gitelman Syndrome; Potassium Depletion
• Interventions: Dietary Supplement: Potassium depletion

• Registration Number: NCT02297048
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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.

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, healthy volunteers will be submitted twice to two periods of normal Na+/ high K+ diet (control period) followed by a normal Na+/ low K+ diet sustained by a pharmacological treatment with Kayexalate (K+-depleted condition). The subjects will be treated with either RU486 or a placebo, according to a randomization. The adrenal response will be evaluated after stimulation by Synacthen at baseline and at the end of each experimental period. A Synacthen test will be also done in 10 patients suffering of chronic hypokalemia linked to a hereditary tubulopathy inducing renal K+ leak called Gitelman syndrome and their plasma steroid profile will be established.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RU 486 (mifepristone)	Potassium depletion	Subjects will receive 400 mg once a day of RU486
Placebo	Potassium depletion	Subjects will receive placebo once a day

Primary Outcome Measures

Name	Time	Method
Effect of potassium depletion on plasma progesterone (Change from Baseline of progesterone)	Day 1 and Day 8 of placebo period of treatment (healthy subjects) or once (Gitelman patients)	Healthy subjects : Change from Baseline of progesterone in response to synacthen at day 8 in subject treated by placebo.; Patients with Gitelman syndrome: Change from Baseline of progesterone in response to synacthen

Secondary Outcome Measures

Name	Time	Method
Effect of potassium depletion on pulse pressure velocity (Pulse wave velocity and central blood pressure)	At Day 1 and Day 8 of each period of treatment	Pulse wave velocity and central blood pressure are measured before and after 7 days of potassium deprivated diet.
Effect of potassium depletion on plasma progesterone under RU486 (Change from Baseline of progesterone)	Day 1 and Day 8 of placebo period of treatment (healthy subjects) or once (Gitelman patients)	Healthy subjects : Change from Baseline of progesterone in response to synacthen at day 8 in subject treated by RU486.
effect of RU 486 on renal adaptation to potassium depletion (Plasma potassium and kaliuresis will be monitored )	Day 1 and day 8 of each period of treatment	Plasma potassium and kaliuresis will be monitored during the 7-days potassium depletion in subjects treated by RU486 or placebo, according randomization

Trial Locations

Locations (1)

European George Pompidou Hospital; 🇫🇷 Paris, France