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

Completed

• Conditions: Primary Hyperparathyroidism

• Registration Number: NCT03831620
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study Start: 2019-02-01
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	2 months	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

Trial Locations

Locations (1)

Department of visceral surgery and transplant surgery, Berne University Hospital; 🇨🇭 Bern, Switzerland