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Acromegaly - Before and After Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431727
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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
Acromegaly Growth Hormone Treatment Sleep Apnea Cardiovascular Diseases Bone Diseases

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
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Study Type : Observational
Estimated 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 : October 1, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sleep apnea [ Time Frame: 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 [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Sphygmocor: central arterial pressure and pulse wave velocity

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


Secondary Outcome Measures :
  1. Heartfunction [ Time Frame: At baseline (time of diagnosis) and at an average of 1 years treatment ]
    Echocardiography

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

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

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

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

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


Biospecimen Retention:   Samples Without DNA
Blood samples and tissue will be kept in a locked freezer thorughout the study period

Eligibility Criteria
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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
Newly diagnosed acromegalic patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy

Contacts and Locations
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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): NCT03431727


Contacts
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Contact: Mai C Arlien-Søborg, MD +45 23837420 mas@clin.au.dk
Contact: Jens Otto L Jørgensen, Professor +45 24800664 joj@clin.au.dk

Locations
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Denmark
Aarhus University Hospital, Department of internal medicine and endocrinologi Recruiting
Aarhus, Denmark, 8000
Contact: Mai C Arlien-Søborg, MD    +45 23837420    mas@clin.au.dk   
Principal Investigator: Jens Otto L Jørgensen, Professor         
Sub-Investigator: Mai C Arlien-Søborg, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jens Otto L Jørgensen, Porfessor Aarhus University Hospital, Department of internal medicine and endocrinology
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03431727    
Other Study ID Numbers: 1-10-72-126-16
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases
Sleep Apnea Syndromes
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Bone Diseases, Endocrine
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases