The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism (Targeting CaSR)

Despite the strong association of hyperparathyroidism with arachidonic acid related lipid signals, little research has been performed over the years. A better understanding of the link between arachidonic acid remodeling, prostaglandin and endocannabinoid production with primary hyperparathyroidism in primary tissue/cells might open up new avenues for biomarker and thus to a potential therapeutic target.

Arachidonic acid remodeling might also have an impact on depression and elevated cytokines in patients with primary hyperparathyroidism. The investigators therefore will assess the correlation between postoperative improvement of PHQ-9 and cytokine levels with arachidonic acid remodeling.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of visceral surgery and transplant surgery, Berne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary hyperparathyroidism with planned surgery

Description

Inclusion Criteria:

• Age ≥ 18 years
• Primary hyperparathyroidism with planned surgery
• Written informed consent

Exclusion Criteria:

• Age <18 years
• Secondary/tertiary hyperparathyroidism
• Renal insufficiency
• Participant is pregnant
• Participant is incapable of giving an informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the level of parathyroid hormone		2 months
Measurement of the level of calcium		2 months
Measurement of the level of cortisol		2 months
Measurement of the level of 25-hydroxyvitamin D		2 months
Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)		2 months
Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids		2 months
Measurement of the level of IL-6 and TNF-α		2 months
Assessment of Patient Health Questionnaire - 9	The Patient Health Questionnaire (PHQ-9) is described as a valid depression scale with good sensitivity and specificity for detecting depressive disorders, ranging from 1 to 27. Depression severity: 1 to 4: minimal; 5 to 9: mild; 10 to 14: moderate; 15 to 19: moderately severe; 20 to 27: severe	2 months

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Reto Kaderli, MD, University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: 2018-02218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No