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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 30, 2020

Detailed Description

1. 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.

2. Analysis of CKD impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination.

3. Assessment of relationship of hormonal dysfunctions in patients with CKD and adipocytokines, markers of renal impairment.

4. To study the effect of renal replacement therapy on thyroid hormones clearance .

5. Investigate hormonal status in patients with CKD after kidney transplantation.

Interventions

  • Other: Ultrasound, DXA, hormonal tests
    • Diagnostic tests in selected groups with investigation of revealed hormonal disorders

Arms, Groups and Cohorts

  • Control
    • 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)
  • CKD 1-2
    • 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)
  • CKD 3-5
    • 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)

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tatiana Mokhort, Professor, MD, Head of Endocrinology Department – Belarusian State Medical University
  • Overall Official(s)
    • Tatiana Mokhort, Prof, Study Chair, Head of Endocrinology Department

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