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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02092129
Other study ID # PROL-BG-ACRO
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 18, 2014
Last updated May 2, 2017
Start date September 2013
Est. completion date December 2017

Study information

Verified date May 2017
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 79
Est. completion date December 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark National University Hospital, Department of Medical Endocrinology Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate glucose metabolic outcome related to pituitary histopathology and plasma hyperprolactinaemia in patients with acromegaly Patients are grouped according to histopathological evaluation of pituitary adenomas
pure GH secreting adenomas or
GH and prolactin co-secreting adenomas.
one year
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