Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03831620
Collaborator
(none)
90
Enrollment
1
Location
41.9
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism
    Actual Study Start Date :
    Feb 1, 2019
    Anticipated Primary Completion Date :
    Jul 31, 2022
    Anticipated Study Completion Date :
    Jul 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Measurement of the level of parathyroid hormone [2 months]

    2. Measurement of the level of calcium [2 months]

    3. Measurement of the level of cortisol [2 months]

    4. Measurement of the level of 25-hydroxyvitamin D [2 months]

    5. Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases) [2 months]

    6. Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids [2 months]

    7. Measurement of the level of IL-6 and TNF-α [2 months]

    8. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of visceral surgery and transplant surgery, Berne University Hospital Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT03831620
    Other Study ID Numbers:
    • 2018-02218
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperparathyroidism
    Hyperparathyroidism, Primary

    Study Results

    No Results Posted as of Oct 12, 2021