Clinical trial NCT04059380: Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Official title: Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism: The EMPATHY Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Peripheral Blood Mononuclear Cells
timeFrame: baseline
Secondary outcomes:
measure: Cell-specific Inflammatory Cytokine expression
timeFrame: baseline
measure: PTHR1 expression
timeFrame: baseline
measure: Inflammatory cytokines levels
timeFrame: baseline
measure: Infectious diseases frequency and severity
timeFrame: baseline
measure: Calcium Signaling evaluation
timeFrame: baseline
measure: Quality of life: SF-36-Item Health Survey questionnaire
timeFrame: baseline
measure: Psychometric evaluation
timeFrame: baseline
measure: Sleep disturbances
timeFrame: baseline
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Experimental Medicine, "Sapienza" University of Rome
Study officials:
References:
citation: 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.