<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01681927</url>
  </required_header>
  <id_info>
    <org_study_id>220488-4</org_study_id>
    <secondary_id>WUH 350-595</secondary_id>
    <nct_id>NCT01681927</nct_id>
  </id_info>
  <brief_title>Study of Idiopathic Edema</brief_title>
  <official_title>Study of Idiopathic Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Winthrop University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Winthrop University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually&#xD;
      exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid&#xD;
      retention syndrome and orthostatic edema.&#xD;
&#xD;
      The present studies were designed to 1. Improve our ability to identify patients with&#xD;
      idiopathic edema by extending the clinical criteria from an increase in weight of &gt; 1.4 kg&#xD;
      between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the&#xD;
      history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema&#xD;
      in idiopathic edema and autonomic failure that will identify a greater number of patients&#xD;
      suffering from variable degrees of weight gain and compare to controls or other conditions&#xD;
      associated with edema. The study will focus mainly on subjects with polycystic ovaries and&#xD;
      autonomic failure. 3. Provide a reasonable course of therapy that is presently not well&#xD;
      defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies,&#xD;
      a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the&#xD;
      lower extremities in autonomic failure due to a lack of vascular tone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All postmenarchal female patients over the age of 14 years will be eligible to enter the&#xD;
      study except for the following exclusions: serum creatinine &gt; 2.0 mg/dl, patients with&#xD;
      diabetes insipidus-nephrogenic and central, those on lithium therapy and diuretics that&#xD;
      cannot be held for 3 days. Subjects under the age of 18 will be asked tp complete the&#xD;
      questionnaire, which requires that the subject record the weights at 8 AM and 10 PM and&#xD;
      whether they get up at night to urines. If they gain more than three pounds during the day&#xD;
      and get up at night to urinate, they will be asked to keep a record of their weights and the&#xD;
      number of times they get up at night to urinate for one week. A consent form for patients&#xD;
      below the age of 18 has been developed for this age-group. Patients will be recruited from&#xD;
      referrals from the different subspecialty groups in the Winthrop Hospital system, mainly&#xD;
      pediatric endocrinology, obstetric and gynecology, neurology, ophthalmology, cardiology and&#xD;
      gastroenterology practices.&#xD;
&#xD;
      The subjects will be placed in the following groups:&#xD;
&#xD;
      Group I: nonedematous patients&#xD;
&#xD;
        1. polycystic ovaries&#xD;
&#xD;
        2. autonomic failure-male and female&#xD;
&#xD;
        3. Age and gender matched normals Group II-Edema not meeting criteria for idiopathic edema&#xD;
&#xD;
      1.Congestive heart failure 2.Cirrhosis of liver 3.Nephrosis 4.Pregnancy 5.Pre eclampsia&#xD;
      6.Unknown cause of edema, such as obesity. Group III-Orthostatic weight gain of &gt; 3 lbs&#xD;
      between 8 AM and 10 PM with nocturia&#xD;
&#xD;
        1. Idiopathic edema, include patients in Group I-fluctuations in weight/nocturia&#xD;
&#xD;
        2. Autonomic failure, include patients in Group I-fluctuations in weight/nocturia&#xD;
&#xD;
      Group III subjects will undergo the following procedures:&#xD;
&#xD;
        1. Record weights in pajamas before bedtime and after excreting first urine upon arising in&#xD;
           the morning for 1 week.&#xD;
&#xD;
        2. Record the number of times they get up to urinate and collect all urines passed&#xD;
           overnight in separate containers, including urine excreted upon arising in the morning.&#xD;
           The patient will record the time and date on each container provided for this purpose.&#xD;
&#xD;
      24 hour study:&#xD;
&#xD;
        1. Blood will be collected after waking up the following morning and at 7 PM the same day.&#xD;
           Blood will be analyzed for renal profile, renin, aldosterone, uric acid, phosphorus&#xD;
&#xD;
        2. All urines excreted from the time after arising in the morning and collected in separate&#xD;
           containers throughout the following 24 hours and the times of collection noted. The&#xD;
           urines will be analyzed for osmolality, sodium, potassium, creatinine, uric acid, urea&#xD;
           and phosphorus.&#xD;
&#xD;
      Bioimpedance Studies:&#xD;
&#xD;
      Patients in group III will have bioimpedance studies performed in the morning upon arising&#xD;
      and in the evening to determine any change in body composition, i.e. change in volume of&#xD;
      extracellular, intracellular and total body water.&#xD;
&#xD;
      Collection of Interstitial Fluid:&#xD;
&#xD;
      In selected patients, an 18g needle will be placed subcutaneously in the mid-thigh and the&#xD;
      interstitial fluid collected by gravity to obtain 2-3 ml of fluid for analysis in late&#xD;
      afternoon. A blood sample will be obtained after completion of the sampling of edema fluid.&#xD;
      The serum will be analyzed for renal profile, total protein, albumin and electrophoresis. The&#xD;
      interstitial fluid will analyzed for renal profile, osmolality, total protein, albumin and&#xD;
      electrophoresis.&#xD;
&#xD;
      Fluorescein dye studies:&#xD;
&#xD;
      Patients in Group III and selected patients with polycystic ovaries without edema over the&#xD;
      age of 18 years will undergo a standard ophthalmologic fluorescein dye test to detect any&#xD;
      increase in vascular endothelial permeability. Patients with diabetes mellitus will be&#xD;
      excluded from this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Orthostatic weight exceeding 1.4 kg/day</measure>
    <time_frame>1 day</time_frame>
    <description>the subject will record weights upon arising and before retiring at night.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nocturia</measure>
    <time_frame>overnight</time_frame>
    <description>The subject will record and save all urines excreted after retiring for the night and upon arising in the morning.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Idiopathic Edema Nocturia</condition>
  <arm_group>
    <arm_group_label>1.4kg wt gain 8AM -10 PM</arm_group_label>
    <description>Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&gt;1.4kg wt gain 8AM - 10PM no nocturia.</arm_group_label>
    <description>Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&gt; 1.4 kg wt gain 8AM -10PM with nocturia</arm_group_label>
    <description>Complete a questionnaire. Measure and record weight in AM and PM. Record the number of times and collect all urine passed overnight in separate containers for one week.Collection of blood and interstitial fluid samples, fluorescein dye angiography, and bioimpedance study.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with idiopathic edema&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects gaining &gt; 1.4 kg and nocturia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those not gaining &gt; 1.4 kg and without nocturia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John K Maesaka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winthrop University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Winthrop-University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>November 2, 2016</last_update_submitted>
  <last_update_submitted_qc>November 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Winthrop University Hospital</investigator_affiliation>
    <investigator_full_name>John Maesaka, MD</investigator_full_name>
    <investigator_title>Acting Chief of Nephrology and Hypertension</investigator_title>
  </responsible_party>
  <keyword>idiopathic edema nocturia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Edema</mesh_term>
    <mesh_term>Nocturia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681927
org study id: 220488-4
secondary id: WUH 350-595
nct id: NCT01681927
lead sponsor: 
has dmc: No
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.
All postmenarchal female patients over the age of 14 years will be eligible to enter the
      study except for the following exclusions: serum creatinine > 2.0 mg/dl, patients with
      diabetes insipidus-nephrogenic and central, those on lithium therapy and diuretics that
      cannot be held for 3 days. Subjects under the age of 18 will be asked tp complete the
      questionnaire, which requires that the subject record the weights at 8 AM and 10 PM and
      whether they get up at night to urines. If they gain more than three pounds during the day
      and get up at night to urinate, they will be asked to keep a record of their weights and the
      number of times they get up at night to urinate for one week. A consent form for patients
      below the age of 18 has been developed for this age-group. Patients will be recruited from
      referrals from the different subspecialty groups in the Winthrop Hospital system, mainly
      pediatric endocrinology, obstetric and gynecology, neurology, ophthalmology, cardiology and
      gastroenterology practices.

      The subjects will be placed in the following groups:

      Group I: nonedematous patients

        1. polycystic ovaries

        2. autonomic failure-male and female

        3. Age and gender matched normals Group II-Edema not meeting criteria for idiopathic edema

      1.Congestive heart failure 2.Cirrhosis of liver 3.Nephrosis 4.Pregnancy 5.Pre eclampsia
      6.Unknown cause of edema, such as obesity. Group III-Orthostatic weight gain of > 3 lbs
      between 8 AM and 10 PM with nocturia

        1. Idiopathic edema, include patients in Group I-fluctuations in weight/nocturia

        2. Autonomic failure, include patients in Group I-fluctuations in weight/nocturia

      Group III subjects will undergo the following procedures:

        1. Record weights in pajamas before bedtime and after excreting first urine upon arising in
           the morning for 1 week.

        2. Record the number of times they get up to urinate and collect all urines passed
           overnight in separate containers, including urine excreted upon arising in the morning.
           The patient will record the time and date on each container provided for this purpose.

      24 hour study:

        1. Blood will be collected after waking up the following morning and at 7 PM the same day.
           Blood will be analyzed for renal profile, renin, aldosterone, uric acid, phosphorus

        2. All urines excreted from the time after arising in the morning and collected in separate
           containers throughout the following 24 hours and the times of collection noted. The
           urines will be analyzed for osmolality, sodium, potassium, creatinine, uric acid, urea
           and phosphorus.

      Bioimpedance Studies:

      Patients in group III will have bioimpedance studies performed in the morning upon arising
      and in the evening to determine any change in body composition, i.e. change in volume of
      extracellular, intracellular and total body water.

      Collection of Interstitial Fluid:

      In selected patients, an 18g needle will be placed subcutaneously in the mid-thigh and the
      interstitial fluid collected by gravity to obtain 2-3 ml of fluid for analysis in late
      afternoon. A blood sample will be obtained after completion of the sampling of edema fluid.
      The serum will be analyzed for renal profile, total protein, albumin and electrophoresis. The
      interstitial fluid will analyzed for renal profile, osmolality, total protein, albumin and
      electrophoresis.

      Fluorescein dye studies:

      Patients in Group III and selected patients with polycystic ovaries without edema over the
      age of 18 years will undergo a standard ophthalmologic fluorescein dye test to detect any
      increase in vascular endothelial permeability. Patients with diabetes mellitus will be
      excluded from this study.
observational model: Case-Only
time perspective: Prospective
measure: Orthostatic weight exceeding 1.4 kg/day
time frame: 1 day
description: the subject will record weights upon arising and before retiring at night.
measure: Nocturia
time frame: overnight
description: The subject will record and save all urines excreted after retiring for the night and upon arising in the morning.
arm group label: 1.4kg wt gain 8AM -10 PM
description: Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.
arm group label: >1.4kg wt gain 8AM - 10PM no nocturia.
description: Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.
arm group label: > 1.4 kg wt gain 8AM -10PM with nocturia
description: Complete a questionnaire. Measure and record weight in AM and PM. Record the number of times and collect all urine passed overnight in separate containers for one week.Collection of blood and interstitial fluid samples, fluorescein dye angiography, and bioimpedance study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John K Maesaka, MD
role: Principal Investigator
affiliation: Winthrop University Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Winthrop University Hospital
investigator full name: John Maesaka, MD
investigator title: Acting Chief of Nephrology and Hypertension
mesh term: Edema
mesh term: Nocturia