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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05243979
Other study ID # Thyroid, Parathyroid CKD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date April 1, 2023

Study information

Verified date February 2022
Source Assiut University
Contact Sara Magdy
Phone 01098777997
Email dr.sara54.sm@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date April 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
DEXA scan
bone study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (8)

Ammirati AL. Chronic Kidney Disease. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s03-s09. doi: 10.1590/1806-9282.66.S1.3. Review. — View 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. — View 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. — View 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. Review. — View Citation

Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2020 Oct;98(4S):S1-S115. doi: 10.1016/j.kint.2020.06.019. — View Citation

Kuczera P, Adamczak M, Wiecek A. Endocrine Abnormalities in Patients with Chronic Kidney Disease. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(2):109-18. doi: 10.1515/prilozi-2015-0059. Review. — View Citation

Laible M, Horstmann S, Rizos T, Rauch G, Zorn M, Veltkamp R. Prevalence of renal dysfunction in ischaemic stroke and transient ischaemic attack patients with or without atrial fibrillation. Eur J Neurol. 2015 Jan;22(1):64-9, e4-5. doi: 10.1111/ene.12528. Epub 2014 Aug 4. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Relation between thyroid , parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease patients in Assiut To evaluate the relation between thyroid, parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease different stages Baseline
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