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Thyroid Dysfunction in Patients With Nephrotic Syndrome

Primary Purpose

Thyroid Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nephrotic patients
Sponsored by
Merna Makram
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Nephrotic syndrome defined by the following:

    1. Generalized edema
    2. Urine protein excretion > 3,5 g/24 hours
    3. Urine protein to creatinine ratio > 3,500mg/g
    4. Serum albumin level less than 30 g/L

Exclusion Criteria:

- 1) Patients < 18 years old 2) Patients who have Thyroid diseases, current or past history of thyroid hormone or antithyroid drug intake.

3) Patients who have diabetes mellitus or autoimmune diseases as systemic lupus erythematosus and RA 4) Medications known to affect thyroid function. 5) Patients with liver cirrhosis and chronic liver disease as augmentin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Nephrotic syndrome patients

    Arm Description

    This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome

    Outcomes

    Primary Outcome Measures

    Hypothyroidism in patients with nephrotic syndrome
    Decrease T3 and/or T4 and/or increase TSH in patients with proteinurea more than 3.5 mg

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2020
    Last Updated
    March 25, 2020
    Sponsor
    Merna Makram
    Collaborators
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04323007
    Brief Title
    Thyroid Dysfunction in Patients With Nephrotic Syndrome
    Official Title
    Thyroid Dysfunction in Patients With Nephrotic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Merna Makram
    Collaborators
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome
    Detailed Description
    Nephrotic syndrome (NS) is one of the most popular glomerular diseases all over the world It result in loss of various macromolecules which exist in the plasma and bound to plasma proteins. They are carried away and lost in the urine due to increase glomerular membrane permeability.The abnormalities arising as a result of persistence of generalized edema , substantial heavy proteinuria >3,5 gm/24 h 3, hypoalbuminemia<30 g/L and hyperlipidemia Also, nephrotic syndrome may associated with thromboembolism and increase risk of infection, vitamin D deficiency, Iron deficiency and endocrine abnormalities such as primary Hypothyroidism.The interaction between kidney and Thyroid hormone is an important factor in the normal functioning of both the vital organs, thyroid hormone play a major role in early development of kidney structurally and regulation of major glomerular and tubular function and water and electrolytes balance .Kidneys on other hand are important in the metabolism and elimination of Thyroid Hormone.The effect of nephrotic syndrome on thyroid function can be explained by presence of proteinuria and loss of Thyroid binding globulins (TBG) in urine which lead to decrease in Total T3,Total T4,free T3 and free T4 and consequently increase in TSH from the pituitary gland with over function of thyroid gland in order to maintain Thyroid hormone levels. Another theory explain association between nephrotic syndrome and thyroid dysfunction is Autoimmunity which can attack both organs and may also cause abnormal function of both organs. Thus, subclinical Hypothyroidism and overt Hypothyroidism may happen in NS patients and CKD patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Dysfunction

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nephrotic syndrome patients
    Arm Type
    Other
    Arm Description
    This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Nephrotic patients
    Intervention Description
    Laboratory measures will include Blood sugar Urine analysis with 24hrs protein in urine Complete blood count Liver function tests Kidney functions test Plasma lipid levels Thyroid functions test Abdominal ultrasound Antithyrperoxidase Renal biopsy
    Primary Outcome Measure Information:
    Title
    Hypothyroidism in patients with nephrotic syndrome
    Description
    Decrease T3 and/or T4 and/or increase TSH in patients with proteinurea more than 3.5 mg
    Time Frame
    1year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Nephrotic syndrome defined by the following: Generalized edema Urine protein excretion > 3,5 g/24 hours Urine protein to creatinine ratio > 3,500mg/g Serum albumin level less than 30 g/L Exclusion Criteria: - 1) Patients < 18 years old 2) Patients who have Thyroid diseases, current or past history of thyroid hormone or antithyroid drug intake. 3) Patients who have diabetes mellitus or autoimmune diseases as systemic lupus erythematosus and RA 4) Medications known to affect thyroid function. 5) Patients with liver cirrhosis and chronic liver disease as augmentin
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Merna Makram
    Phone
    01060230012
    Email
    monnajesus246@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa Haridi, Prof
    Phone
    01001079913

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29020719
    Citation
    McCloskey O, Maxwell AP. Diagnosis and management of nephrotic syndrome. Practitioner. 2017 Feb;261(1801):11-5.
    Results Reference
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    PubMed Identifier
    4431166
    Citation
    Bradley SE, Stephan F, Coelho JB, Reville P. The thyroid and the kidney. Kidney Int. 1974 Nov;6(5):346-65. doi: 10.1038/ki.1974.119. No abstract available.
    Results Reference
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    Thyroid Dysfunction in Patients With Nephrotic Syndrome

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