NCT04059380

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypoparathyroidism
• Hypoparathyroidism Postprocedural
• Hypoparathyroidism Due to Impaired Parathormone Secretion

Timeline

• Start date: 2019-05-13
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2019-08-16
• Last updated: 2022-12-06

Locations

1 site across 1 country: Italy