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

NCT04059380 | Completed

• 1 other identifier: EMPATHY
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Peripheral Blood Mononuclear Cells

  Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations

  baseline

Secondary Outcomes (8)

• Cell-specific Inflammatory Cytokine expression

  baseline

• PTHR1 expression

  baseline

• Inflammatory cytokines levels

  baseline

• Infectious diseases frequency and severity

  baseline

• Calcium Signaling evaluation

  baseline

Study Arms (2)

Patients with Hypoparathyroidism

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

Healthy Controls

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Experimental Medicine, "Sapienza" University of Rome

Rome, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 33484559 DERIVED

MeSH Terms

Conditions

Hypoparathyroidism; Hypocalcemia; Parasomnias

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: May 13, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

IT (1)