Physiopathology of Sodium Retention in Acromegaly (AcromEnaC)
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|ClinicalTrials.gov Identifier: NCT00531908|
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : December 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acromegaly||Drug: furosemide||Not Applicable|
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.
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physiopathology of Sodium Retention in Acromegaly|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly
- To compare natriuretic effect of a single dose administration of amiloride (20 mg) in patients with acromegaly [ Time Frame: before and after treatment of acromegaly. ]
- To compare natriuretic effect of a single dose of furosemide (bolus 5 mg, then 10 mg over 2 hrs) in patients with acromegaly [ Time Frame: before and after treatment of acromegaly. ]
- To study the difference of the intranasal potential [ Time Frame: before and after treatment of acromegaly. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531908
|Paris, France, 75000|
|Principal Investigator:||Peter KAMENICKY, MD||Assistance Publique - Hôpitaux de Paris|