ThyroidNCT05243979
The Relation Between Thyroid , Parathyroid Hormones and eGFR in CKD Patients in Assiut
An observational study of Thyroid and Parathyroid Diseases, run by Assiut University.
Trial summary
To evaluate the relation between thyroid, parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid, Parathyroid Diseases, CKD
- What is being tested?
- DEXA scan
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Assuit University Hospital -Internal medicine department (Inpatient and outpatient settings).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Thyroid, Parathyroid Diseases, CKD
- Being tested
- DEXA scan
- Keywords
- Thyroid, Parathyroid Diseases, CKD
- Medical subject headings
- Thyroid Diseases, Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA scanRadiation
bone study
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | 40 patients with CKD (1-3) not on renal replacement therapy. Receives: Radiation: DEXA scan | |
| Group (B) | 40 persons with normal kidney function and GFR ( control ). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Ahmed Mohammed, Assiut University
- Investigators
- Sara Magdy, Study chair, Assiut UniversityHanan Mahmoud, Study chair, Assiut UniversityNashwa Mostafa, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243979
- Sponsor's protocol ID
- Thyroid, Parathyroid CKD
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. No abstract available.
PubMed 32998798Laible 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.
PubMed 25091540Banerjee 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.
PubMed 31064752Ammirati 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.
PubMed 31939529Kuczera 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.
PubMed 27442377Peters 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.
PubMed 33682051Guo 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.
PubMed 31914999Habas 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.
PubMed 34408941
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Thyroid , Parathyroid Hormones and Estimated Glomerular Filtration Rate in Chronic Kidney Disease Patients in Assiut
- ClinicalTrials.gov ID
- NCT05243979
- Acronym / sponsor ID
- Thyroid, Parathyroid CKD
- Conditions
- Thyroid, Parathyroid Diseases, CKD
- Keywords
- Thyroid, Parathyroid Diseases, CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | – | Radiation: DEXA scan40 patients with CKD (1-3) not on renal replacement therapy. |
| Group (B) | – | –40 persons with normal kidney function and GFR ( control ). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Assuit University Hospital -Internal medicine department (Inpatient and outpatient settings).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA scanbone study | Radiation | Group (A) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 32998798Kidney 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. No abstract available.
- Background: PubMed 25091540Laible 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.
- Background: PubMed 31064752Banerjee 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.
- Background: PubMed 31939529Ammirati 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.
- Background: PubMed 27442377Kuczera 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.
- Background: PubMed 33682051Peters 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.
- Background: PubMed 31914999Guo 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.
- Background: PubMed 34408941Habas 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.
Related trials for Thyroid
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Recruiting
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
Thyroid Nodule (Diagnosis)
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
RecruitingPhase 2
Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Magdy study chair
Assiut University
Hanan Mahmoud study chair
Assiut University
Nashwa Mostafa study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Parathyroid Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Magdy (01098777997, dr.sara54.sm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Relation between thyroid , parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease patients in Assiut (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243979, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.