Brief Title
Physiopathology of Sodium Retention in Acromegaly
Official Title
Physiopathology of Sodium Retention in Acromegaly
Brief Summary
Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults induces an increase in bone (resulting in large enlargement of extremities), and organs. The disease is complicated by the apparition of cardiovascular events including retention of water, salt in the tissues and increase in blood pressure, that altogether might major the mortality of the patients. The investigators recently got experimental data suggesting that the retention of water and salt is mainly due to the activation by the growth hormone of a renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a well know diuretic, the investigators hypothesize that this drug will be very efficient in treating the hypertension in patients, as compared to another diuretic, furosemide.
Detailed Description
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
Study Type
Interventional
Primary Outcome
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly
Secondary Outcome
To compare natriuretic effect of a single dose of furosemide (bolus 5 mg, then 10 mg over 2 hrs) in patients with acromegaly
Condition
Acromegaly
Intervention
furosemide
Study Arms / Comparison Groups
A
Description: To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
September 2007
Completion Date
December 2009
Primary Completion Date
December 2009
Eligibility Criteria
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Peter KAMENICKY, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00531908
Organization ID
P061012
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor
Peter KAMENICKY, MD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
August 2008