Clinical trial NCT04439747: Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease
Official title: Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperprolactinemia
Thyroid Dysfunction
Bone Diseases, Metabolic
Chronic Kidney Diseases
Keywords: hormonal alterations, RRT, CKD, kidney transplantation
Lead sponsor: Belarusian State Medical University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of nephrology departments in Minsk City hospitals and endocrinology department of Minsk Endocrinology Dispensary from which 2 groups will be selected , healthy volunteers of Minsk as control group

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.

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.

Primary outcomes:
measure: Hormanal changes in patients with CKD
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Belarusian State Medical University Endocrinology Department
Study officials:
affiliation: Head of Endocrinology Department
name: Tatiana Mokhort, Prof
role: STUDY_CHAIR
References: