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OpenTrials
Completed

NCT Number: NCT03831620

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

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.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of visceral surgery and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: Targeting CaSR

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2019
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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