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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-13

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy with Central Lymph Node Compartment Dissection

NCT04339478

Thyroid Cancer Thyroidectomy with Central Lymph Node Dissection

COMPLETED

Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

NCT03309384

Endocrine Procedural Complications Thyroid Parathyroid; Deficiency +1 more

RECRUITING

Study of the Prevalence of Osteo-metabolic Complications in Patients With Thyroid Cancer

NCT06627998

Cancer of Thyroid Vertebral Fracture Osteoporosis

RECRUITING

Dysthyroidism and Female Sexual Function

NCT03093285

Sexuality Thyroid

UNKNOWN

Validation of a Hypoparathyroidism Self-questionnaire

NCT05642741

Thyroidectomy Hypoparathyroidism Postprocedural

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoparathyroidism Hypoparathyroidism Postprocedural Hypoparathyroidism Due to Impaired Parathormone Secretion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Hypoparathyroidism

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

No interventions assigned to this group

Healthy Controls

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes