PheochromocytomaNCT01949714
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue
An observational study of Pheochromocytoma and Adrenal Incidentaloma, run by University of Aarhus at 1 site in Denmark.
Trial summary
To investigate the effect of catecholamine excess on brown fat. To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Adrenal Incidentaloma
- What is being tested?
- Removal of adrenal tumor
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Jan 2022
- 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: Patients with adrenal tumors
Who may be able to join
- 10 patients with pheochromocytoma
- 5 patients with incidentaloma without hormone production
- Age > 18 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology MEA, Aarhus Hospital
Aarhus C, Please Select, 8000
About this study
- To investigate the effect of catecholamine excess on brown fat.
- To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism
- Conditions
- Pheochromocytoma, Adrenal Incidentaloma
- Being tested
- Removal of adrenal tumor
- Medical subject headings
- Pheochromocytoma, Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of adrenal tumorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pheochromocytoma patients | Pheochromocytoma patients Receives: Procedure: Removal of adrenal tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]FDG uptake in brown adipose tissue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esben Søndergaard, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949714
- Sponsor's protocol ID
- ES-0005
- Status last verified
- May 2022
- First submitted
- 20 Sep 2013
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue
- ClinicalTrials.gov ID
- NCT01949714
- Acronym / sponsor ID
- ES-0005
- Conditions
- Pheochromocytoma, Adrenal Incidentaloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 24 Sep 2013 (estimated)
- 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.
- To investigate the effect of catecholamine excess on brown fat.
- To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pheochromocytoma patients | – | Procedure: Removal of adrenal tumorPheochromocytoma patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adrenal tumors
Key inclusion criteria (3 listed)
- 10 patients with pheochromocytoma
- 5 patients with incidentaloma without hormone production
- Age > 18 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of adrenal tumor | Procedure or surgery | Pheochromocytoma patients |
Primary outcome
[18F]FDG uptake in brown adipose tissue
Time frame: 3 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 23 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pheochromocytoma and Adrenal Incidentaloma, run by University of Aarhus at 1 site in Denmark.
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 1 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 23 May 2022. 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 Denmark. 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?
[18F]FDG uptake in brown adipose tissue (time frame: 3 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 23 May 2022.