- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05243979
The Relation Between Thyroid , Parathyroid Hormones and eGFR in CKD Patients in Assiut
The Relation Between Thyroid , Parathyroid Hormones and Estimated Glomerular Filtration Rate in Chronic Kidney Disease Patients in Assiut
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sara Magdy
- Phone Number: 01098777997
- Email: dr.sara54.sm@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group (A)
40 patients with CKD (1-3) not on renal replacement therapy.
|
bone study
|
|
Group (B)
40 persons with normal kidney function and GFR ( control ).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Relation between thyroid , parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease patients in Assiut
Time Frame: Baseline
|
To evaluate the relation between thyroid, parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease different stages
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sara Magdy, Assiut University
- Study Chair: Hanan Mahmoud, Assiut University
- Study Chair: Nashwa Mostafa, Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Thyroid, Parathyroid CKD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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