NCT03431727

Brief Summary

The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

5.2 years

First QC Date

December 22, 2017

Last Update Submit

December 4, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sleep apnea

    ApneaLinkAir: respiratory effort, puls, oxygen saturation, nasal flow and snoring

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • Circulation

    Sphygmocor: central arterial pressure and pulse wave velocity

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • Bone metabolism

    HRpQCT scan

    At baseline (time of diagnosis) and at an average of 1 years treatment

Secondary Outcomes (6)

  • Heartfunction

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • Substrate metabolism; signaling proteins

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • Substrate metabolism; gene targets

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • Energy expenditure

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • Body composition

    At baseline (time of diagnosis) and at an average of 1 years treatment

  • +1 more secondary outcomes

Eligibility Criteria

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

Newly diagnosed acromegalic patients

You may qualify if:

  • Recently diagnosed with acromegaly
  • Age above 18
  • Written consent

You may not qualify if:

  • \- Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of internal medicine and endocrinologi

Aarhus, 8000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and tissue will be kept in a locked freezer thorughout the study period

MeSH Terms

Conditions

AcromegalySleep Apnea SyndromesCardiovascular DiseasesBone Diseases

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Jens Otto L Jørgensen, Porfessor

    Aarhus University Hospital, Department of internal medicine and endocrinology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mai C Arlien-Søborg, MD

CONTACT

Jens Otto L Jørgensen, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

February 13, 2018

Study Start

October 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations