Thyroid Dysfunction in Patients With Nephrotic Syndrome

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

Study Overview

• Status: Unknown
• Conditions: Thyroid Dysfunction
• Intervention / Treatment: Diagnostic test: Nephrotic patients

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothyroidism in patients with nephrotic syndrome	Decrease T3 and/or T4 and/or increase TSH in patients with proteinurea more than 3.5 mg	1year

Collaborators and Investigators

• Sponsor: Merna Makram
• Collaborators: Assiut University

Publications and helpful links

General Publications

• McCloskey O, Maxwell AP. Diagnosis and management of nephrotic syndrome. Practitioner. 2017 Feb;261(1801):11-5.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Thyroid Diseases; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: Thyroid Dysfunction

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No