Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pheochromocytoma; Paraganglioma
• Intervention / Treatment: Other: Catecholamines

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Xian-Liang Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with dysglycemia; Patients with dysglycemia in the included subjects with pheochromocytoma and paraganglioma	Other: Catecholamines; Focus on whether catecholamine exposure is associated with dysglycemia in patients with pheochromocytoma and paraganglioma
patients without dysglycemia; Patients without dysglycemia in the included subjects with pheochromocytoma and paraganglioma	Other: Catecholamines; Focus on whether catecholamine exposure is associated with dysglycemia in patients with pheochromocytoma and paraganglioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	baseline, 6-12 months after surgery

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Xian-Liang Zhou, National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2022
• Primary Completion (ANTICIPATED): July 20, 2022
• Study Completion (ANTICIPATED): July 20, 2022

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (ACTUAL): July 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pheochromocytoma; Paraganglioma; dysglycemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Pheochromocytoma; Paraganglioma
• Other Study ID Numbers: 2022-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No