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

NCT04439747 | Unknown DMC

• 1 other identifier: 20180438
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hormonal alterations, RRT, CKD, kidney transplantation

Outcome Measures

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

  Baseline

Study Arms (3)

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

Ultrasound, DXA, hormonal tests OTHER

Diagnostic tests in selected groups with investigation of revealed hormonal disorders

CKD 1-2; CKD 3-5; Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Belarusian State Medical University: lead

Study Sites (1)

Belarusian State Medical University Endocrinology Department

Minsk, 220040, Belarus

Location

MeSH Terms

Conditions

Hyperprolactinemia; Bone Diseases, Metabolic; Renal Insufficiency, Chronic

Interventions

High-Energy Shock Waves; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tatiana Mokhort, Prof

  Head of Endocrinology Department

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Head of Endocrinology Department

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)