ClinicalTrials.gg
CompletedNCT03831620Targeting CaSRUpdated Jan 26, 2023

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

An observational study in Primary Hyperparathyroidism, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Hyperparathyroidism
03

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's enrollment of 90 is below the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Primary hyperparathyroidism with planned surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Secondary/tertiary hyperparathyroidism
  • Renal insufficiency
  • Participant is pregnant
  • Participant is incapable of giving an
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Target follow-up
2 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation

    Time frame: 2 months

Secondary outcomes

  1. Measurement of the level of parathyroid hormone

    Time frame: 2 months

  2. Measurement of the level of calcium

    Time frame: 2 months

  3. Measurement of the level of cortisol

    Time frame: 2 months

  4. Measurement of the level of 25-hydroxyvitamin D

    Time frame: 2 months

  5. Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)

    Time frame: 2 months

  6. Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids

    Time frame: 2 months

  7. Measurement of the level of IL-6 and TNF-α

    Time frame: 2 months

  8. 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

    Time frame: 2 months

07

Study locations

1 site
  • Department of visceral surgery and transplant surgery, Berne University Hospital
    Bern, 3010, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03831620
Responsible party
Sponsor
First posted
Feb 6, 2019
Start date
Feb 1, 2019
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022
Last update
Jan 26, 2023

Study contacts

Reto Kaderli, MD
principal investigator · Insel Gruppe AG, University Hospital Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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