Study of Idiopathic Edema

Completed

Conditions studied: Idiopathic Edema Nocturia

In brief

Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid retention syndrome and orthostatic edema. The present studies were designed to 1. Improve our ability to identify patients with idiopathic edema by extending the clinical criteria from an increase in weight of \> 1.4 kg between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema in idiopathic edema and autonomic failure that will identify a greater number of patients suffering from variable degrees of weight gain and compare to controls or other conditions associated with edema. The study will focus mainly on subjects with polycystic ovaries and autonomic failure. 3. Provide a reasonable course of therapy that is presently not well defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies, a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the lower extremities in autonomic failure due to a lack of vascular tone.

Key facts

Study ID

NCT01681927

Run by

Winthrop University Hospital

People needed

4

Starts

2011-09-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subjects gaining > 1.4 kg and nocturia

You may not qualify if…

• those not gaining > 1.4 kg and without nocturia

Where it is running

• Winthrop-University Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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