Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney disease (CKD) will be developed and implemented in real clinical practice. As a result of the project, new scientific data will be obtained on the relationship of hyperprolactinemia and impaired functioning of the pituitary-gonadal axis, changes in functioning of the renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid and parathyroid status in patients with CKD will be determined, including receiving renal replacement therapy (RRT) and after kidney transplantation, which will improve the efficiency of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce the direct financial costs of the diagnostic and treatment process primarily due to the optimization of hormonal studies and treatment of the revealed disorders, as well as will prevent the progression of CKD and the severity of the condition of this category of patients due to the development of hormonal dysfunctions.

Detailed Description
-----------------
Assessment of prevalence, clinical manifestations and pathological significance in a cohort of patients with CKD: hyperprolactinemia, hormonal disorders of a pituitary -gonad axis ; disorders of renin-angiotensin-aldosterone system; pathology of the thyroid and parathyroid glands. Analysis of CKD impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination. Assessment of relationship of hormonal dysfunctions in patients with CKD and adipocytokines, markers of renal impairment. To study the effect of renal replacement therapy on thyroid hormones clearance . Investigate hormonal status in patients with CKD after kidney transplantation.

Official Title
-----------------
Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease

Conditions
-----------------
Hyperprolactinemia, Thyroid Dysfunction, Bone Diseases, Metabolic, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: Ultrasound, DXA, hormonal tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients at CKD 1-5, including renal replacement therapy and renal transplantation Exclusion Criteria: patients with impaired thyroid function before the onset of CKD; pregnant women; patients with acute diseases; patients in the acute phase of comorbid chronic diseases; patients in the acute period of myocardial infarction, after acute cerebrovascular accident; patients with mental illness; patients undergoing treatment for various cancer types.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, neutrophil- gelatinase assosiated lipocalin-2 (NGAL), adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, antibodies to thyroid peroxidase (Ab-TPO), Ab--R-TSH, Ab-Tg, parathyroid hormone (PTH), vitamin D, osteocalcin, b-cross-laps, prolactin) | Other: Ultrasound, DXA, hormonal tests<br>* Diagnostic tests in selected groups with investigation of revealed hormonal disorders<br>|
| CKD 1-2<br>Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, NGAL, adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, Ab-TPO, Ab--R-TSH, Ab-Tg, PTH, vitamin D, osteocalcin, b-cross-laps, prolactin) | Other: Ultrasound, DXA, hormonal tests<br>* Diagnostic tests in selected groups with investigation of revealed hormonal disorders<br>|
| CKD 3-5<br>Ultrasound examination of the thyroid gland and parathyroid glands, osteodensitometry (DXA), biochemical analysis, general blood count, NGAL, adiponectin, urine albumin / creatinine ratio, hormonal tests (TSH, free T4 and T3, total T4 and T3, Tg, Ab-TPO, Ab--R-TSH, Ab-Tg, PTH, vitamin D, osteocalcin, b-cross-laps,prolactin) | Other: Ultrasound, DXA, hormonal tests<br>* Diagnostic tests in selected groups with investigation of revealed hormonal disorders<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormanal changes in patients with CKD | Deviations from reference interval ranges of prolactin, thyroid hormones, PTH and vitamin D and its associations with renal impairment markers | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormonal alterations, RRT, CKD, kidney transplantation