Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)

University of Roma La Sapienza

Status: Completed

Conditions: Hypoparathyroidism Postprocedural; Hypoparathyroidism; Hypoparathyroidism Due to Impaired Parathormone Secretion

Study type: Observational

Funder types: Other

Identifiers

NCT04059380

EMPATHY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Patients with Hypoparathyroidism

Description:

Patients with Post-Surgical or Autoimmune Chronic Hypoparathyroidism requiring daily calcium and calcitriol therapy

Healthy Controls

Description:

Age-, sex- and BMI- matched patients referring to our center for diagnostic procedures not affected by hypoparathyroidism