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Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT02092129
Collaborator
(none)
79
Enrollment
1
Location
51
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. The study population include 79 patients who have all undergone surgical treatment for acromegaly.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. 79 patients who have all undergone surgical treatment for acromegaly are included. Clinical and biochemical baseline data are collected from medical records. Patients are divided into two groups based on histopathological evaluation of pituitary adenomas;

    1. pure GH secreting adenomas or

    2. GH and prolactin co-secreting adenomas.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    79 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prognostic Value of Pituitary Histopathology and Plasma Hyperprolactinaemia in Predicting the Risk of Glucose Metabolic Disturbances in Patients With Acromegaly.
    Study Start Date :
    Sep 1, 2013
    Anticipated Primary Completion Date :
    Aug 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Acromegaly

    Patients with acromegaly who have received surgical treatment

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate glucose metabolic outcome related to pituitary histopathology and plasma hyperprolactinaemia in patients with acromegaly [one year]

      Patients are grouped according to histopathological evaluation of pituitary adenomas pure GH secreting adenomas or GH and prolactin co-secreting adenomas.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of acromegaly, and treated at the department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark (tertiary referral hospital), surgical treatment of acromegaly
    Exclusion Criteria:
    • no surgical treatment performed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National University Hospital, Department of Medical Endocrinology Copenhagen Denmark DK-2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Ulla Feldt-Rasmussen, Professor, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ulla Feldt-Rasmussen, Professor, Chief Physician, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT02092129
    Other Study ID Numbers:
    • PROL-BG-ACRO
    First Posted:
    Mar 19, 2014
    Last Update Posted:
    May 3, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ulla Feldt-Rasmussen, Professor, Chief Physician, Rigshospitalet, Denmark
    Acromegaly, surgery, histopathology, hyperprolactinaemia,
    Additional relevant MeSH terms:
    Acromegaly
    Hyperprolactinemia

    Study Results

    No Results Posted as of May 3, 2017