HyperprolactinemiaNCT04439747
Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease
An observational study of Hyperprolactinemia and Thyroid Dysfunction, run by Belarusian State Medical University at 1 site in Belarus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperprolactinemia, Thyroid Dysfunction, Bone Diseases, Metabolic
- What is being tested?
- Ultrasound, DXA, hormonal tests
- How many people
- 400 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- patients at CKD 1-5, including renal replacement therapy and renal transplantation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belarus1 site
Belarusian State Medical University Endocrinology Department
Minsk, 220040
About this study
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
- 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.
- Analysis of CKD impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination.
- Assessment of relationship of hormonal dysfunctions in patients with CKD and adipocytokines, markers of renal impairment.
- To study the effect of renal replacement therapy on thyroid hormones clearance .
- Investigate hormonal status in patients with CKD after kidney transplantation.
- Conditions
- Hyperprolactinemia, Thyroid Dysfunction, Bone Diseases, Metabolic, Chronic Kidney Diseases
- Being tested
- Ultrasound, DXA, hormonal tests
- Keywords
- hormonal alterations, RRT, CKD, kidney transplantation
- Medical subject headings
- Hyperprolactinemia, Bone Diseases, Metabolic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound, DXA, hormonal testsOther
Diagnostic tests in selected groups with investigation of revealed hormonal disorders
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Ultrasound, DXA, hormonal tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jan 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Mokhort, Belarusian State Medical University
- Investigators
- Tatiana Mokhort, Prof, Study chair, Head of Endocrinology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439747
- Sponsor's protocol ID
- 20180438
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04439747
- Acronym / sponsor ID
- 20180438
- Conditions
- Hyperprolactinemia, Thyroid Dysfunction, Bone Diseases, Metabolic, Chronic Kidney Diseases
- Keywords
- hormonal alterations, RRT, CKD, kidney transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Analysis of CKD impact on the development of structural changes in the thyroid gland and parathyroid glands according to the results of ultrasound examination.
- Assessment of relationship of hormonal dysfunctions in patients with CKD and adipocytokines, markers of renal impairment.
- To study the effect of renal replacement therapy on thyroid hormones clearance .
- Investigate hormonal status in patients with CKD after kidney transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Ultrasound, DXA, hormonal testsUltrasound 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) |
| CKD 1-2 | – | Other: Ultrasound, DXA, hormonal testsUltrasound 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) |
| CKD 3-5 | – | Other: Ultrasound, DXA, hormonal testsUltrasound 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients at CKD 1-5, including renal replacement therapy and renal transplantation
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound, DXA, hormonal testsDiagnostic tests in selected groups with investigation of revealed hormonal disorders | Other | CKD 1-2, CKD 3-5, Control |
Primary outcome
Hormanal changes in patients with CKD
Time frame: Baseline
Deviations from reference interval ranges of prolactin, thyroid hormones, PTH and vitamin D and its associations with renal impairment markers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Mokhort, Prof study chair
Head of Endocrinology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperprolactinemia and Thyroid Dysfunction, run by Belarusian State Medical University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormanal changes in patients with CKD (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.