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| Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Institut National de la Santé Et de la Recherche Médicale, France |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00531908 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Acromegaly |
Drug: furosemide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Physiopathology of Sodium Retention in Acromegaly |
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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A: Experimental
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly
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Drug: furosemide
furosemide
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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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter KAMENICKY, MD | +33 (0)1 45 21 37 05 |
| France | |
| Hopital Bicetre | Recruiting |
| PARIS, France, 75000 | |
| Contact: Peter KAMENICKY, MD +33 (0)1 45 21 37 05 | |
| Principal Investigator: | Peter KAMENICKY, MD | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Department of Clinical Research ( Valérie MILLUL ) |
| Study ID Numbers: | P061012, RCB 2007-002619-25 |
| Study First Received: | September 18, 2007 |
| Last Updated: | August 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00531908 |
| Health Authority: | France: Ministry of Health |
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Growth Hormone Epithelial sodium channel Hypertension A Furosemide Nasal Mucosa |
|
Bone Diseases, Endocrine Hypothalamic Diseases Metabolic Diseases Pituitary Diseases Central Nervous System Diseases Endocrine System Diseases Urinary Retention Brain Diseases Furosemide |
Bone Diseases Musculoskeletal Diseases Hypernatremia Water-Electrolyte Imbalance Endocrinopathy Metabolic disorder Acromegaly Hypertension |
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Membrane Transport Modulators Hyperpituitarism Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Nervous System Diseases Cardiovascular Agents Sodium Potassium Chloride Symporter Inhibitors Pharmacologic Actions |
