Pituitary Adenoma and Serum Lipid

May 10, 2022 updated by: Jia-jun Zhao, Shandong Provincial Hospital

Effects of Pituitary Adenoma Resection on Serum Lipid Level

Pituitary adenomas are usually benign monoclonal neoplasms caused by a mixture of pituicyte alterations together with a changed endocrine and paracrine regulatory milieu. Thus, it can cause serious health problems such as abnormal target organ function, pain, disability and even death. In clinical practice, we found many patients with pituitary adenomas are usually accompanied by hyperlipidemia, which is the main cause of cardiovascular diseases. However, it has been unclear if there is an association between pituitary adenomas and serum lipid profile. In the present study, we aim to focus on the patients with pituitary adenomas and their lipid profile before and after operation including first occurrence and recurrence.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with pituitary adenomas and underwent an endoscopic transsphenoidal approach at the Shandong Provincial Hospital affiliated with Shandong University. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.

Description

Inclusion Criteria:

  1. Patients diagnosed with pituitary adenomas
  2. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.

Exclusion Criteria:

  1. Missing vital data, such as age, gender, serum lipid profile, pathology reports;
  2. Complications or conditions that affect pituitary status and lipid metabolism, such as pregnancy, malignant adenomas or severe hepatic or renal dysfunction and
  3. Use of any medication that affects the pituitary or lipid metabolism, including statins, fibrates, thyroid hormones, anti-thyroid drugs, iodine, amiodarone, alemtuzumab, lithium, tyrosine kinase inhibitors, interferon, estrogens, androgens,glucocorticoids, nonsteroidal anti-inflammatory drugs, antiepileptic drugs, rifampicin, furosemide, heparin or β-adrenoceptor blockers in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with pituitary adenomas resection
Patients suffers from pituitary adenomas and undergo transsphenoidal surgery for at least once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum lipid levels
Time Frame: Measured at pre-operative and 6 months after operation
Measured at pre-operative and 6 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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