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

NCT ID: NCT04439747

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-12-31

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

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.

Conditions

Hyperprolactinemia; Thyroid Dysfunction; Bone Diseases, Metabolic; Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Ultrasound, DXA, hormonal tests

Intervention Type: OTHER

Diagnostic tests in selected groups with investigation of revealed hormonal disorders

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)

Ultrasound, DXA, hormonal tests

Intervention Type: OTHER

Diagnostic tests in selected groups with investigation of revealed hormonal disorders

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)

Ultrasound, DXA, hormonal tests

Intervention Type: OTHER

Diagnostic tests in selected groups with investigation of revealed hormonal disorders

Interventions

Ultrasound, DXA, hormonal tests

Diagnostic tests in selected groups with investigation of revealed hormonal disorders

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Belarusian State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Tatiana Mokhort

Professor, MD, Head of Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tatiana Mokhort, Prof

Role: STUDY_CHAIR

Head of Endocrinology Department

Locations

Belarusian State Medical University Endocrinology Department

Minsk, , Belarus

Countries

Belarus

Other Identifiers

20180438

Identifier Type: -

Identifier Source: org_study_id