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Physiopathology of Sodium Retention in Acromegaly

Physiopathology of Sodium Retention in Acromegaly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00531908
Acronym
AcromEnaC
Enrollment
12
Registered
2007-09-19
Start date
2007-09-30
Completion date
2009-12-31
Last updated
2011-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Growth Hormone, Epithelial sodium channel, Hypertension, A Furosemide, Nasal Mucosa

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

Interventions

DRUGfurosemide

furosemide

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegalybefore and after treatment of acromegaly.

Secondary

MeasureTime frame
To compare natriuretic effect of a single dose of furosemide (bolus 5 mg, then 10 mg over 2 hrs) in patients with acromegalybefore and after treatment of acromegaly.
To study the difference of the intranasal potentialbefore and after treatment of acromegaly.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026