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Status unknownNCT04439747Updated Jun 23, 2020

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

An observational study in Hyperprolactinemia, Thyroid Dysfunction and Bone Diseases, Metabolic, sponsored by Belarusian State Medical University. Status unknown at 1 site in Belarus. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.

Sponsored by Belarusian State Medical University · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

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

Keywords

  • hormonal alterations, RRT, CKD, kidney transplantation
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

  • patients at CKD 1-5, including renal replacement therapy and renal transplantation

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

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)

    Other: Ultrasound, DXA, hormonal tests

  • 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)

    Other: Ultrasound, DXA, hormonal tests

  • 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)

    Other: Ultrasound, DXA, hormonal tests

Interventions

  • OtherUltrasound, DXA, hormonal tests

    Diagnostic tests in selected groups with investigation of revealed hormonal disorders

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

06

Study locations

1 site
  • Belarusian State Medical University Endocrinology Department
    Minsk, 220040, Belarus
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04439747
Lead sponsor
Belarusian State Medical University
Responsible party
Tatiana Mokhort (Professor, MD, Head of Endocrinology Department, Belarusian State Medical University) — Principal investigator
First posted
Jun 19, 2020
Start date
Jan 1, 2018
Primary completion
Jun 30, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jun 23, 2020

Study contacts

Tatiana Mokhort, Prof
study chair · Head of Endocrinology Department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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