PheochromocytomaNCT05451134
Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma
An observational study of Pheochromocytoma and Paraganglioma, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The investigators will retrospectively analyze the clinical data of consecutive patients with pheochromocytomas and paragangliomas admitted between January 2018 and June 2020. The clinical characteristics of patients with and without dysglycemia will be compared, and whether surgery could improve the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- Catecholamines
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 20 Jul 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: This retrospective cohort study will include all consecutive adult patients who underwent surgery for pheochromocytomas and paragangliomas from January 2018 to June 2020.
Who may be able to join
- age ≥18 years old
- patients with surgical pathological diagnosis of pheochromocytomas and paragangliomas(PPGLs)
Who cannot join
- recurrent PPGLs
- patients who required steroids after adrenalectomy
- patients with inadequate clinical records were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will retrospectively analyze the clinical data of consecutive patients with pheochromocytomas and paragangliomas admitted between January 2018 and June 2020. The clinical characteristics of patients with and without dysglycemia will be compared, and whether surgery could improve the patients'dysglycemia will be also investigated.
Read the detailed description
This retrospective cohort study will include all consecutive adult patients who underwent surgery for PHEOs and catecholamine-secreting PGLs from January 2018 to June 2020. Patients with recurrent PPGLs, those who required steroids after adrenalectomy, and those with inadequate clinical records were excluded. The patients' electronic medical files were reviewed. Patients with dysglycemia included those with diabetes, or impaired fasting glucose, or impaired glucose tolerance. Clinical history data such as age, sex, body mass index (BMI), the presence of preoperative symptoms, biochemical test results, and tumor characteristics, such as tumor diameters and locations were extracted and analyzed.
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- Catecholamines
- Keywords
- Pheochromocytoma, Paraganglioma, dysglycemia
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatecholaminesOther
Focus on whether catecholamine exposure is associated with dysglycemia in patients with pheochromocytoma and paraganglioma
| Study group | Role | What they receive |
|---|---|---|
| patients with dysglycemia | Patients with dysglycemia in the included subjects with pheochromocytoma and paraganglioma Receives: Other: Catecholamines | |
| patients without dysglycemia | Patients without dysglycemia in the included subjects with pheochromocytoma and paraganglioma Receives: Other: Catecholamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline OGTT（oral glucose tolerance test）results to 6-12 months after surgery
OGTT results （including fasting blood glucose in the text, blood glucose results at 2 hours after oral administration of 75g glucose）at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia
Measured: Baseline, 6-12 months after surgery
Secondary outcomes (3)
random blood glucose results
random blood glucose results at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia
Measured: baseline, 6-12 months after surgery
HbA1c
HbA1c results at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia
Measured: baseline, 6-12 months after surgery
fasting blood glucose
fasting blood glucose results at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia
Measured: baseline, 6-12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start30 Jun 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
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 China National Center for Cardiovascular DiseasesThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Xian-Liang Zhou, Principal investigator, National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451134
- Sponsor's protocol ID
- 2022-06
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma
- ClinicalTrials.gov ID
- NCT05451134
- Acronym / sponsor ID
- 2022-06
- Conditions
- Pheochromocytoma, Paraganglioma
- Keywords
- Pheochromocytoma, Paraganglioma, dysglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 11 Jul 2022 (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.
The investigators will retrospectively analyze the clinical data of consecutive patients with pheochromocytomas and paragangliomas admitted between January 2018 and June 2020. The clinical characteristics of patients with and without dysglycemia will be compared, and whether surgery could improve the patients'dysglycemia will be also investigated.
Detailed description
This retrospective cohort study will include all consecutive adult patients who underwent surgery for PHEOs and catecholamine-secreting PGLs from January 2018 to June 2020. Patients with recurrent PPGLs, those who required steroids after adrenalectomy, and those with inadequate clinical records were excluded. The patients' electronic medical files were reviewed. Patients with dysglycemia included those with diabetes, or impaired fasting glucose, or impaired glucose tolerance. Clinical history data such as age, sex, body mass index (BMI), the presence of preoperative symptoms, biochemical test results, and tumor characteristics, such as tumor diameters and locations were extracted and analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with dysglycemia | – | Other: CatecholaminesPatients with dysglycemia in the included subjects with pheochromocytoma and paraganglioma |
| patients without dysglycemia | – | Other: CatecholaminesPatients without dysglycemia in the included subjects with pheochromocytoma and paraganglioma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study will include all consecutive adult patients who underwent surgery for pheochromocytomas and paragangliomas from January 2018 to June 2020.
Key inclusion criteria (2 listed)
- age ≥18 years old
- patients with surgical pathological diagnosis of pheochromocytomas and paragangliomas(PPGLs)
Key exclusion criteria (3 listed)
- recurrent PPGLs
- patients who required steroids after adrenalectomy
- patients with inadequate clinical records were excluded.
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 |
|---|---|---|
| CatecholaminesFocus on whether catecholamine exposure is associated with dysglycemia in patients with pheochromocytoma and paraganglioma | Other | patients with dysglycemia, patients without dysglycemia |
Primary outcome
Change from baseline OGTT（oral glucose tolerance test）results to 6-12 months after surgery
Time frame: Baseline, 6-12 months after surgery
OGTT results （including fasting blood glucose in the text, blood glucose results at 2 hours after oral administration of 75g glucose）at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia
3 secondary outcomes
random blood glucose results
Time frame: baseline, 6-12 months after surgery
HbA1c
Time frame: baseline, 6-12 months after surgery
fasting blood glucose
Time frame: baseline, 6-12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
Xian-Liang Zhou principal investigator
National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences
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 Paraganglioma, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jul 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 China. 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?
Results are not available in the source record.
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?
Change from baseline OGTT（oral glucose tolerance test）results to 6-12 months after surgery (time frame: Baseline, 6-12 months after surgery). 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 12 Jul 2022.