NCT03831620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

January 25, 2019

Last Update Submit

January 24, 2023

Conditions

Outcome Measures

Primary Outcomes (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 Outcomes (8)

  • Measurement of the level of parathyroid hormone

    2 months

  • Measurement of the level of calcium

    2 months

  • Measurement of the level of cortisol

    2 months

  • Measurement of the level of 25-hydroxyvitamin D

    2 months

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

    2 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary hyperparathyroidism with planned surgery

You may qualify if:

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

You may not qualify if:

  • Age \<18 years
  • Secondary/tertiary hyperparathyroidism
  • Renal insufficiency
  • Participant is pregnant
  • Participant is incapable of giving an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of visceral surgery and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Reto Kaderli, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 6, 2019

Study Start

February 1, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations