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Thyroid Dysfunction in Patients With Nephrotic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323007
Recruitment Status : Unknown
Verified March 2020 by Merna Makram, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Merna Makram, Assiut University

Study Description
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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

Condition or disease Intervention/treatment Phase
Thyroid Dysfunction Diagnostic Test: Nephrotic patients Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Thyroid Dysfunction in Patients With Nephrotic Syndrome
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Nephrotic syndrome patients
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
 Diagnostic Test: Nephrotic patients
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


Outcome Measures
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Primary Outcome Measures :
  1. Hypothyroidism in patients with nephrotic syndrome [ Time Frame: 1year ]
    Decrease T3 and/or T4 and/or increase TSH in patients with proteinurea more than 3.5 mg


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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): NCT04323007


Contacts
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Contact: Merna Makram 01060230012 monnajesus246@gmail.com
Contact: Mostafa Haridi, Prof 01001079913

Sponsors and Collaborators
Merna Makram
Assiut University
More Information
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Publications:

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Responsible Party: Merna Makram, Thyroid Dysfunction in patients with nephrotic syndrome, Assiut University
ClinicalTrials.gov Identifier: NCT04323007    
Other Study ID Numbers: Thyroid Dysfunction
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Thyroid Diseases
 Endocrine System Diseases
Kidney Diseases
Urologic Diseases