HypoparathyroidismEMPATHYNCT04059380
Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
An observational study of Hypoparathyroidism and Hypoparathyroidism Postprocedural, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism, Hypoparathyroidism Postprocedural, Hypoparathyroidism Due to Impaired Parathormone Secretion
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2019to 31 Oct 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 patients with post-surgical or autoimmune hypoparathyroidism and 20 age-, sex- and BMI- matched controls, referring to our center for diagnostic procedures for suspected other endocrinopathies, not affected by hypoparathyroidism
Who may be able to join
- Previously diagnosed (at least 6 months before enrolment) hypoparathyroidism which required daily calcium (≥1000mg/die) and calcitriol therapy;
- Signed informed consent to participate in the study.
Who cannot join
- Transient hypoparathyroidism;
- History of neoplasms, radiotherapy or chemotherapy in the last 5 years;
- Clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic disease;
- Severe infections, surgery, trauma requiring hospitalization within 3 months before enrolment;
- Severe chronic kidney disease (stage 4-5);
- Any active blood or rheumatic disorders in the last 5 years
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Experimental Medicine, "Sapienza" University of Rome
Rome, 00161
About this study
Official title: Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism: The EMPATHY Study
This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls.
Read the detailed description
This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls.
All patients with Hypoparathyroidism will be on established conventional therapy with calcium supplements and calcitriol. According to guidelines, possible confounding factors (i.e. Vitamin D, serum magnesium levels) will be evaluated at screening visit. Age-, sex- and BMI- matched healthy controls will be enrolled.
Patients and controls will undergo a screening visit (V0) and a baseline visit (V1) in the following month.
The primary outcome will be the immune profiling of patients with hypoparathyroidism compared to healthy controls by the quantification of peripheral blood mononuclear cells (PBMC) subpopulations assessed by flow cytometry.
Secondary Outcome Measures will be:
Functional evaluation of PBMC cytokine secretion assessed by flow cytometry
Evaluation of calcium signaling components expression compared to healthy controls
Evaluation of PTHR1 expression in immune cells compared to healthy controls
Evaluation of inflammatory cytokines production compared to healthy controls.
Evaluation of quality of life compared to healthy controls. Quality of life will be measured by Short Form (SF)-36-Item Health Survey total score, SF-36-Item Health Survey physical component summary score and SF-36-Item Health Survey mental component summary score.
Evaluation of infectious diseases frequencies and severity compared to healthy controls. Infectious diseases will be evaluated by an adaptation of Infectious Diseases Questionnaire (GNC).
Psychometric evaluation by self-administered questionnaires: Beck depression Index, Middlesex Hospital Questionnaire.
Sleep disturbances evaluation by The Pittsburgh Sleep Quality Index (PSQI) self reported questionnaire.
- Conditions
- Hypoparathyroidism, Hypoparathyroidism Postprocedural, Hypoparathyroidism Due to Impaired Parathormone Secretion
- Keywords
- parathormone, hypoparathyroidism, parathyroid, hypocalcemia, immunity, immune function, quality of life, sleep disturbances, parathyroid hormone
- Medical subject headings
- Hypoparathyroidism, Hypocalcemia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hypoparathyroidism | Patients with Post-Surgical or Autoimmune Chronic Hypoparathyroidism requiring daily calcium and calcitriol therapy | |
| Healthy Controls | Age-, sex- and BMI- matched patients referring to our center for diagnostic procedures not affected by hypoparathyroidism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Blood Mononuclear Cells
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
Measured: baseline
Secondary outcomes (8)
Cell-specific Inflammatory Cytokine expression
Cell-specific Cytokine expression by flow cytometry - Composite outcome measure of Tumor Necrosis Factor α (TNFα), Transforming Growth Factor-β (TGF-β) and Interferon-γ (IFN-γ) intracellular concentration
Measured: baseline
PTHR1 expression
Measurement of PTHR1 expression by Prime Flow RNA assay
Measured: baseline
Inflammatory cytokines levels
Chemiluminescence measurement of TNFα, TGF-β and IFN-γ serum concentrations.
Measured: baseline
Infectious diseases frequency and severity
Frequencies and severity of infectious diseases will be evaluated by modified Infectious Diseases Questionnaire (GNC).
This questionnaire includes questions on infectious diseases of upper and lower respiratory tract, gastrointestinal tract, skin and urogenital tract contracted during the previous 12 months. Questions investigate on the number and duration of infections, necessity of antibiotic or antifungal therapy, hospital stay and days of absence from work. Final score represents the frequency of infections. Moreover, some questions investigate possible susceptible or protective factors for infectious diseases: vaccinations, use of corticosteroids, concomitant diseases, previous appendectomy, tonsillectomy, adenoidectomy, splenectomy or thymectomy.
Measured: baseline
Calcium Signaling evaluation
Composite outcome consisting of simultaneous measurement of calcium channels and related proteins: Cav1, Calcium Release Activating Channel, Stromal Interaction Molecule 1 (STIM1), Calcium release-activated calcium modulator 1 (encoded by Orai1 gene), Inositol trisphosphate receptor, Nuclear factor of activated T-cells, Calcineurin and Nuclear Factor Kappa-Light-Chain-Enhancer of Activated B cells (NF-kB) expression evaluated by Prime Polymerase chain reaction
Measured: baseline
Quality of life: SF-36-Item Health Survey questionnaire
Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire.
This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component).
Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state.
Measured: baseline
Psychometric evaluation
Psychometric evaluation will be assessed by the scores of two self-administered questionnaires: Beck depression Index and Middlesex Hospital Questionnaire.
Beck depression Index is a 21-item measure of depressive symptoms. Each answer is scored on a scale value (from 0 to 3 points). The global score is obtained adding all single scores, with a range of 0-63. Higher score constitutes worse burden of symptoms (0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression) Middlesex Hospital Questionnaire is a self-rating inventory measuring aspects of six distinct categories of psychoneurosis and affective status. Considering symptoms gravity or frequency each answer is scored on a scale value (from 0 to 2 points). Category scores derive from the addition of the scores of 8 questions. Specific cut off are used to distinguish between normal and pathological behavior (anxiety 5, phobia 5, obsession 7, somatization 5, depression 4 and hysteria 4).
Measured: baseline
Sleep disturbances
Sleep disturbances will be evaluated by The Pittsburgh Sleep Quality Index (PSQI). This questionnaire contains 19 self-related questions which are combined to create 7 component scores with a range of 0-3 points (0:no difficulty, 3: severe difficulty). Global score is the result to the addition of all component scores with a range of 0-21 points (0:no difficulty, 21: severe difficulty).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start13 May 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Isidori, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059380
- Sponsor's protocol ID
- EMPATHY
- Acronym
- EMPATHY
- Status last verified
- Dec 2022
- First submitted
- 14 Aug 2019
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Puliani G, Hasenmajer V, Sciarra F, Barbagallo F, Sbardella E, Pofi R, Gianfrilli D, Romagnoli E, Venneri MA, Isidori AM. Impaired Immune Function in Patients With Chronic Postsurgical Hypoparathyroidism: Results of the EMPATHY Study. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2215-e2227. doi: 10.1210/clinem/dgab038.
PubMed 33484559
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism: The EMPATHY Study
- ClinicalTrials.gov ID
- NCT04059380
- Acronym / sponsor ID
- EMPATHY / EMPATHY
- Conditions
- Hypoparathyroidism, Hypoparathyroidism Postprocedural, Hypoparathyroidism Due to Impaired Parathormone Secretion
- Keywords
- parathormone, hypoparathyroidism, parathyroid, hypocalcemia, immunity, immune function, quality of life, sleep disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 16 Aug 2019 (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.
This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls.
Detailed description
This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls.
All patients with Hypoparathyroidism will be on established conventional therapy with calcium supplements and calcitriol. According to guidelines, possible confounding factors (i.e. Vitamin D, serum magnesium levels) will be evaluated at screening visit. Age-, sex- and BMI- matched healthy controls will be enrolled.
Patients and controls will undergo a screening visit (V0) and a baseline visit (V1) in the following month.
The primary outcome will be the immune profiling of patients with hypoparathyroidism compared to healthy controls by the quantification of peripheral blood mononuclear cells (PBMC) subpopulations assessed by flow cytometry.
Secondary Outcome Measures will be:
Functional evaluation of PBMC cytokine secretion assessed by flow cytometry
Evaluation of calcium signaling components expression compared to healthy controls
Evaluation of PTHR1 expression in immune cells compared to healthy controls
Evaluation of inflammatory cytokines production compared to healthy controls.
Evaluation of quality of life compared to healthy controls. Quality of life will be measured by Short Form (SF)-36-Item Health Survey total score, SF-36-Item Health Survey physical component summary score and SF-36-Item Health Survey mental component summary score.
Evaluation of infectious diseases frequencies and severity compared to healthy controls. Infectious diseases will be evaluated by an adaptation of Infectious Diseases Questionnaire (GNC).
Psychometric evaluation by self-administered questionnaires: Beck depression Index, Middlesex Hospital Questionnaire.
Sleep disturbances evaluation by The Pittsburgh Sleep Quality Index (PSQI) self reported questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Hypoparathyroidism | – | –Patients with Post-Surgical or Autoimmune Chronic Hypoparathyroidism requiring daily calcium and calcitriol therapy |
| Healthy Controls | – | –Age-, sex- and BMI- matched patients referring to our center for diagnostic procedures not affected by hypoparathyroidism |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with post-surgical or autoimmune hypoparathyroidism and 20 age-, sex- and BMI- matched controls, referring to our center for diagnostic procedures for suspected other endocrinopathies, not affected by hypoparathyroidism
Key inclusion criteria (2 listed)
- Previously diagnosed (at least 6 months before enrolment) hypoparathyroidism which required daily calcium (≥1000mg/die) and calcitriol therapy;
- Signed informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Transient hypoparathyroidism;
- History of neoplasms, radiotherapy or chemotherapy in the last 5 years;
- Clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic disease;
- Severe infections, surgery, trauma requiring hospitalization within 3 months before enrolment;
- Severe chronic kidney disease (stage 4-5);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral Blood Mononuclear Cells
Time frame: baseline
Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations
8 secondary outcomes
Cell-specific Inflammatory Cytokine expression
Time frame: baseline
PTHR1 expression
Time frame: baseline
Inflammatory cytokines levels
Time frame: baseline
Infectious diseases frequency and severity
Time frame: baseline
Calcium Signaling evaluation
Time frame: baseline
Quality of life: SF-36-Item Health Survey questionnaire
Time frame: baseline
Psychometric evaluation
Time frame: baseline
Sleep disturbances
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 33484559Puliani G, Hasenmajer V, Sciarra F, Barbagallo F, Sbardella E, Pofi R, Gianfrilli D, Romagnoli E, Venneri MA, Isidori AM. Impaired Immune Function in Patients With Chronic Postsurgical Hypoparathyroidism: Results of the EMPATHY Study. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2215-e2227. doi: 10.1210/clinem/dgab038.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoparathyroidism and Hypoparathyroidism Postprocedural, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 6 Dec 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peripheral Blood Mononuclear Cells (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04059380, which also lists 1 linked publication.
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 6 Dec 2022.