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

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ClinicalTrials.gov Identifier: NCT03831620
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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
Primary Hyperparathyroidism

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022





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 [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary hyperparathyroidism with planned surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831620


Contacts
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Contact: Reto Kaderli, MD +41 31 632 23 26 reto.kaderli@insel.ch
Contact: Chiara Ziegler, RN +31 632 23 26 chiara.ziegler@inse.ch

Locations
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Switzerland
Department of visceral surgery and transplant surgery, Berne University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Reto Kaderli    +41 31 632 23 26    reto.kaderli@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Reto Kaderli, MD University Hospital Inselspital, Berne

Additional Information:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03831620     History of Changes
Other Study ID Numbers: 2018-02218
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs