NCT02092129

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

March 18, 2014

Last Update Submit

May 2, 2017

Conditions

Keywords

Acromegaly, surgery, histopathology, hyperprolactinaemia,

Outcome Measures

Primary Outcomes (1)

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

    one year

Study Arms (1)

Acromegaly

Patients with acromegaly who have received surgical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acromegaly treated with surgery

You may qualify if:

  • Diagnosis of acromegaly, and treated at the department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark (tertiary referral hospital), surgical treatment of acromegaly

You may not qualify if:

  • no surgical treatment performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Department of Medical Endocrinology

Copenhagen, DK-2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

AcromegalyHyperprolactinemia

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Ulla Feldt-Rasmussen, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 19, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations