Physiopathology of Sodium Retention in Acromegaly
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: furosemide (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Peter KAMENICKY, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Peter KAMENICKY, MD, Phone: +33 (0)1 45 21 37 05
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.
Clinical Details
Official title: Physiopathology of Sodium Retention in Acromegaly
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 acromegalyTo study the difference of the intranasal potential
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 Bicêtre 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Peter KAMENICKY, MD, Phone: +33 (0)1 45 21 37 05
Hopital Bicetre, PARIS 75000, France; Recruiting
Peter KAMENICKY, MD, Phone: +33 (0)1 45 21 37 05
Additional Information
Research department connected to the clinical department of endocrinology
Starting date: September 2007
Ending date: September 2009
Last updated: August 28, 2008
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