Clinical trial NCT05243979: The Relation Between Thyroid , Parathyroid Hormones and eGFR in CKD Patients in Assiut
Official title: The Relation Between Thyroid , Parathyroid Hormones and Estimated Glomerular Filtration Rate in Chronic Kidney Disease Patients in Assiut
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid
Parathyroid Diseases
CKD
Keywords: Thyroid
Parathyroid Diseases
CKD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Assuit University Hospital -Internal medicine department (Inpatient and outpatient settings).

Brief summary: To evaluate the relation between thyroid, parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease .

Detailed description: CKD is defined as abnormalities of kidney structure or function, present for \>3 months, with implications for health. CKD is classified based on Cause, GFR category (G1-G5), and Albuminuria category (A1-A3) .

The global prevalence of CKD is 13.4%, with 10.6% being stages 3-5 ,Over the past 10 years, the death rate due to CKD has increased by 31.7% .

CKD patients remain sometimes asymptomatic, presenting the complications typical of renal dysfunction only in more advanced stages. Its treatment can be conservative usually in patients with glomerular filtration rate above 15 ml/minute without indications of dialysis or replacement therapy .

In CKD patients the changes of endocrine system levels may arise from several causes as the kidney is the site of degradation \& synthesis of many different hormones .

So thyroid and parathyroid hormones dysfunction has been recognized as common co-morbidity that is often diagnosed with CKD .

Thyroid hormone is one of the most important hormones in the human body as it regulates majority of the body's physiological actions .

Parathyroid hormone (PTH) is one of the most important hormones required for the maintenance of calcium and phosphate homeostasis .

Chronic kidney disease metabolic bone disorder (CKD-MBD) among patients with end stage renal disease ranges from 33% to 67%, and its severity tends to increase with the progression of the kidney damage \& high mortality rates .

CKD-MBD causes bone abnormalities that affect turnover, volume, mineralization, vascular, linear growth, and density, and soft tissue calcification .

Eligibility criteria: Inclusion Criteria:

* 1. CKD patients 2. Age (18-80 years) 3. Diabetic nephropathy 4. Hypertensive nephropathy 5. Chronic pyelonephritis 6. Obstructive nephropathy 7. Polycystic kidney 8. Gout nephropathy 9. Nephrosclerosis

Exclusion Criteria:

* 1. Patients underage of 18 and above 80 2. Patients with history of thyroidectomy and parathyroidectomy 3. Patients with history of thyroid and parathyroid disease before diagnosis of CKD 4. Malignancy

Primary outcomes:
measure: The Relation between thyroid , parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease patients in Assiut
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Sara Magdy
role: STUDY_CHAIR
affiliation: Assiut University
name: Hanan Mahmoud
role: STUDY_CHAIR
affiliation: Assiut University
name: Nashwa Mostafa
role: STUDY_CHAIR
References:
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citation: Banerjee D, Jha V. Vitamin D and Cardiovascular Complications of CKD: What's Next? Clin J Am Soc Nephrol. 2019 Jun 7;14(6):932-934. doi: 10.2215/CJN.12581018. Epub 2019 May 7. No abstract available.
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citation: Peters J, Roumeliotis S, Mertens PR, Liakopoulos V. Thyroid hormone status in patients with impaired kidney function. Int Urol Nephrol. 2021 Nov;53(11):2349-2358. doi: 10.1007/s11255-021-02800-2. Epub 2021 Mar 8.
citation: Guo Y, Wang Q, Lu C, Fan P, Li J, Luo X, Chen D. New parathyroid function index for the differentiation of primary and secondary hyperparathyroidism: a case-control study. BMC Endocr Disord. 2020 Jan 8;20(1):5. doi: 10.1186/s12902-019-0487-8.
citation: Habas E Sr, Eledrisi M, Khan F, Elzouki AY. Secondary Hyperparathyroidism in Chronic Kidney Disease: Pathophysiology and Management. Cureus. 2021 Jul 14;13(7):e16388. doi: 10.7759/cureus.16388. eCollection 2021 Jul.