The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism

Primary Hyperparathyroidism Clinical Trial

— Targeting CaSR  

Official title:

The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831620
• Other study ID #: 2018-02218
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: January 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Locations

Country	Name	City	State
Switzerland	Department of visceral surgery and transplant surgery, Berne University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation		2 months
Secondary	Measurement of the level of parathyroid hormone		2 months
Secondary	Measurement of the level of calcium		2 months
Secondary	Measurement of the level of cortisol		2 months
Secondary	Measurement of the level of 25-hydroxyvitamin D		2 months
Secondary	Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)		2 months
Secondary	Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids		2 months
Secondary	Measurement of the level of IL-6 and TNF-a		2 months
Secondary	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