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

Hypoparathyroidism Clinical Trial

Official title:
Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism: The EMPATHY Study

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

  • Hypoparathyroidism
  • Hypoparathyroidism Due to Impaired Parathormone Secretion
  • Hypoparathyroidism Postprocedural
Clinical Trial Details
NCT number NCT04059380
Study type Observational
Source University of Roma La Sapienza
Contact
Status Completed
Phase
Start date May 13, 2019
Completion date October 31, 2020
View Details
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