Clincosm LogoSign in Get a demo

Acromegaly - Before and After Treatment

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT03431727
Collaborator
(none)
20
Enrollment
1
Location
62
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acromegaly is a rare disease caused by a growth hormone (GH) producing pituitary adenoma. Surgery is primary treatment, whereas medical treatment with a somatostatin analogue (SA), which suppresses GH secretion and reduces tumour size, is used when surgery is insufficient or unfeasible. Acromegaly is associated with metabolic abnormalities which contributes to an increased morbidity and mortality if left untreated. To which extend these abnormalities reverses after treatment, and if treatment modality influences the outcome, remain elusive. The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment
    Actual Study Start Date :
    Oct 1, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Sleep apnea [At baseline (time of diagnosis) and at an average of 1 years treatment]

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

    2. Circulation [At baseline (time of diagnosis) and at an average of 1 years treatment]

      Sphygmocor: central arterial pressure and pulse wave velocity

    3. Bone metabolism [At baseline (time of diagnosis) and at an average of 1 years treatment]

      HRpQCT scan

    Secondary Outcome Measures

    1. Heartfunction [At baseline (time of diagnosis) and at an average of 1 years treatment]

      Echocardiography

    2. Substrate metabolism; signaling proteins [At baseline (time of diagnosis) and at an average of 1 years treatment]

      Western blotting

    3. Substrate metabolism; gene targets [At baseline (time of diagnosis) and at an average of 1 years treatment]

      qPCR

    4. Energy expenditure [At baseline (time of diagnosis) and at an average of 1 years treatment]

      Indirect calorimetry

    5. Body composition [At baseline (time of diagnosis) and at an average of 1 years treatment]

      DXA scan

    6. Physical activity [At baseline (time of diagnosis) and at an average of 1 years treatment]

      Sensoriband

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Recently diagnosed with acromegaly

    • Age above 18

    • Written consent

    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital, Department of internal medicine and endocrinologi Aarhus Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    • Principal Investigator: Jens Otto L Jørgensen, Porfessor, Aarhus University Hospital, Department of internal medicine and endocrinology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT03431727
    Other Study ID Numbers:
    • 1-10-72-126-16
    First Posted:
    Feb 13, 2018
    Last Update Posted:
    Dec 7, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acromegaly
    Bone Diseases
    Sleep Apnea Syndromes
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Dec 7, 2020