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
About this trial
This is an interventional diagnostic trial for Thyroid Dysfunction
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
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
NCT ID
NCT04323007
First Posted
January 12, 2020
Last Updated
March 25, 2020
Sponsor
Merna Makram
Collaborators
Assiut University
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
background
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
background
Learn more about this trial
Thyroid Dysfunction in Patients With Nephrotic Syndrome
We'll reach out to this number within 24 hrs