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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Effect of potassium depletion on plasma progesterone (Change from Baseline of progesterone) [ Time Frame: 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • effect of RU 486 on renal adaptation to potassium depletion (Plasma potassium and kaliuresis will be monitored ) [ Time Frame: 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
  • Effect of potassium depletion on pulse pressure velocity (Pulse wave velocity and central blood pressure) [ Time Frame: 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) [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 29, 2014
Date Started: July 2014
Date Completion:
Last Updated: September 30, 2015
Last Verified: September 2015