Thyroid Dysfunction in Patients With Nephrotic Syndrome

NCT ID: NCT04323007

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-01

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

Conditions

Thyroid Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Nephrotic patients

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Merna Makram

OTHER

Sponsor Role: lead

Responsible Party

Merna Makram

Thyroid Dysfunction in patients with nephrotic syndrome

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Merna Makram

Role: CONTACT

monnajesus246@gmail.com

01060230012

Mostafa Haridi, Prof

Role: CONTACT

01001079913

References

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

Reference Type: BACKGROUND

PMID: 29020719 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4431166 (View on PubMed)

Other Identifiers

Thyroid Dysfunction

Identifier Type: -

Identifier Source: org_study_id