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

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ClinicalTrials.gov Identifier: NCT02092129
Recruitment Status : Unknown
Verified May 2017 by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

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
Acromegaly Surgery

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.

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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 : September 2013
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Acromegaly
Patients with acromegaly who have received surgical treatment



Primary Outcome Measures :
  1. Evaluate glucose metabolic outcome related to pituitary histopathology and plasma hyperprolactinaemia in patients with acromegaly [ Time Frame: one year ]

    Patients are grouped according to histopathological evaluation of pituitary adenomas

    1. pure GH secreting adenomas or
    2. GH and prolactin co-secreting adenomas.


Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acromegaly treated with surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092129


Locations
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Denmark
National University Hospital, Department of Medical Endocrinology
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark

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Responsible Party: Ulla Feldt-Rasmussen, Professor, Chief Physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02092129     History of Changes
Other Study ID Numbers: PROL-BG-ACRO
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark:
Acromegaly, surgery, histopathology, hyperprolactinaemia,
Additional relevant MeSH terms:
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Acromegaly
Hyperprolactinemia
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism