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

Belarusian State Medical University

Status: Unknown

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

Treatments: Other: Ultrasound, DXA, hormonal tests

Study type: Observational

Funder types: Other

Identifiers

NCT04439747

20180438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

400 participants in 3 patient groups

Control

Description:

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)

Treatment:

Other: Ultrasound, DXA, hormonal tests

CKD 1-2

Description:

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)

Treatment:

Other: Ultrasound, DXA, hormonal tests

CKD 3-5

Description:

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)

Treatment:

Other: Ultrasound, DXA, hormonal tests