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Physiopathology of Sodium Retention in Acromegaly

18 Years
75 Years
Not Enrolling

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Trial Information

Physiopathology of Sodium Retention in Acromegaly

To prove this, we compared the response to amiloride administrated before and after
treatment of acromegaly in the same subject. We will also compare the response to furosemide
administrated before and after treatment of acromegaly in the same subject. We expected that
the response to amiloride will be greater before than after treatment, while the response to
furosemide will be lesser before than after treatment.

Detailed Description:

Definition: Extended description of the protocol, including information not already
contained in other fields, such as comparison(s) studied.

Patients will be recruited in the Department of Endocrinology and Reproductive diseases in
BICETRE University Hospital and will be explored in the Centre for Clinical Investigation of
HEGP. Investigations will be performed during 4 separate day-hospital stays (2 pre-treatment
and 2 post treatment) in the CIC of HEGP. The tests will consist of blood and urine sample
collections before and after a single dose administration of furosemide or amiloride. The
tests will be performed before treatment of acromegaly in random order and separated by
48hours, interval performed before treatment, and repeated in the same order after
normalization of IGF1 by appropriate treatment.

The study will last for 2 years, with a 12 months maximal participation of each patient

Inclusion Criteria:

- age 18 to 75 yrs

- proven evolutive acromegalia with indication of treatment (surgical or medical)

- controlled blood pressure (systolic BP < 140 mmHg et diastolic BP < 90 mmHg)

- signed informed consent

- efficient contraception in women

Exclusion Criteria:

- edematous state unrelated to acromegaly

- history of sulfamide intolerance

- hemoglobin < 8g/dL

- pregnant or breastfeeding women

- inability to give informed consent

- blood donation in the preceding 3 months

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly

Outcome Time Frame:

before and after treatment of acromegaly.

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

September 2007

Completion Date:

December 2009

Related Keywords:

  • Acromegaly
  • Growth Hormone
  • Epithelial sodium channel
  • Hypertension
  • A Furosemide
  • Nasal Mucosa
  • Acromegaly
  • Hypernatremia