Primary HyperparathyroidismTargeting CaSRNCT03831620
The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism
An observational study of Primary Hyperparathyroidism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2019to 31 Jul 2022
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary hyperparathyroidism with planned surgery
Who may be able to join
- Age ≥ 18 years
- Primary hyperparathyroidism with planned surgery
- Written informed consent
Who cannot join
- Age <18 years
- Secondary/tertiary hyperparathyroidism
- Renal insufficiency
- Participant is pregnant
- Participant is incapable of giving an informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of visceral surgery and transplant surgery, Berne University Hospital
Bern, 3010
About this study
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.
- Conditions
- Primary Hyperparathyroidism
- Medical subject headings
- Hyperparathyroidism, Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation
Measured: 2 months
Secondary outcomes (8)
Measurement of the level of parathyroid hormone
Measured: 2 months
Measurement of the level of calcium
Measured: 2 months
Measurement of the level of cortisol
Measured: 2 months
Measurement of the level of 25-hydroxyvitamin D
Measured: 2 months
Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)
Measured: 2 months
Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids
Measured: 2 months
Measurement of the level of IL-6 and TNF-α
Measured: 2 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Feb 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto Kaderli, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831620
- Sponsor's protocol ID
- 2018-02218
- Other IDs
- 2018
- Acronym
- Targeting CaSR
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03831620
- Acronym / sponsor ID
- Targeting CaSR / 2018-02218
- Conditions
- Primary Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary hyperparathyroidism with planned surgery
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Primary hyperparathyroidism with planned surgery
- Written informed consent
Key exclusion criteria (5 listed)
- Age <18 years
- Secondary/tertiary hyperparathyroidism
- Renal insufficiency
- Participant is pregnant
- Participant is incapable of giving an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Measurement of the level of parathyroid hormone
Time frame: 2 months
Measurement of the level of calcium
Time frame: 2 months
Measurement of the level of cortisol
Time frame: 2 months
Measurement of the level of 25-hydroxyvitamin D
Time frame: 2 months
Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)
Time frame: 2 months
Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids
Time frame: 2 months
Measurement of the level of IL-6 and TNF-α
Time frame: 2 months
Assessment of Patient Health Questionnaire - 9
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reto Kaderli, MD principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.