NCT05451134

Brief 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 patients'dysglycemia will be also investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 30, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

July 12, 2022

Status Verified

June 1, 2022

Enrollment Period

20 days

First QC Date

June 30, 2022

Last Update Submit

July 9, 2022

Conditions

Keywords

PheochromocytomaParagangliomadysglycemia

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 6-12 months after surgery

Secondary Outcomes (3)

  • random blood glucose results

    baseline, 6-12 months after surgery

  • HbA1c

    baseline, 6-12 months after surgery

  • fasting blood glucose

    baseline, 6-12 months after surgery

Study Arms (2)

patients with dysglycemia

Patients with dysglycemia in the included subjects with pheochromocytoma and paraganglioma

Other: Catecholamines

patients without dysglycemia

Patients without dysglycemia in the included subjects with pheochromocytoma and paraganglioma

Other: Catecholamines

Interventions

Focus on whether catecholamine exposure is associated with dysglycemia in patients with pheochromocytoma and paraganglioma

patients with dysglycemiapatients without dysglycemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • age ≥18 years old
  • patients with surgical pathological diagnosis of pheochromocytomas and paragangliomas(PPGLs)

You may not qualify if:

  • recurrent PPGLs
  • patients who required steroids after adrenalectomy
  • patients with inadequate clinical records were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xian-Liang Zhou

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

PheochromocytomaParaganglioma

Interventions

Catecholamines

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

AminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Xian-Liang Zhou

    National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 11, 2022

Study Start

June 30, 2022

Primary Completion

July 20, 2022

Study Completion

July 20, 2022

Last Updated

July 12, 2022

Record last verified: 2022-06

Locations