AcromegalyNCT03431727
Acromegaly - Before and After Treatment
An observational study of Acromegaly and Growth Hormone Treatment, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Growth Hormone Treatment, Sleep Apnea
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed acromegalic patients
Who may be able to join
- Recently diagnosed with acromegaly
- Age above 18
- Written consent
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Department of internal medicine and endocrinologi
Aarhus, 8000
Mai C Arlien-Søborg, MD, +45 23837420, mas@clin.au.dk
Jens Otto L Jørgensen, Professor
About this study
Official title: Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment
The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.
Read the 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
- Medical subject headings
- Acromegaly, Sleep Apnea Syndromes, Cardiovascular Diseases, Bone Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnea
ApneaLinkAir: respiratory effort, puls, oxygen saturation, nasal flow and snoring
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Circulation
Sphygmocor: central arterial pressure and pulse wave velocity
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Bone metabolism
HRpQCT scan
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Secondary outcomes (6)
Heartfunction
Echocardiography
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Substrate metabolism; signaling proteins
Western blotting
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Substrate metabolism; gene targets
qPCR
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Energy expenditure
Indirect calorimetry
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Body composition
DXA scan
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Physical activity
Sensoriband
Measured: At baseline (time of diagnosis) and at an average of 1 years treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Oct 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Otto L Jørgensen, Porfessor, Principal investigator, Aarhus University Hospital, Department of internal medicine and endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431727
- Sponsor's protocol ID
- 1-10-72-126-16
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2017
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek A, Christiansen Arlien-Soborg M, Pedersen AKN, Dal J, Madsen MA, Hogild ML, Berryman D, Kopchick JJ, Pedersen SB, Bjerre M, Lebeck J, Jessen N, Jorgensen JOL. Growth hormone causes reversible fibrosis in muscle and fat: a study in patients with acromegaly. Eur J Endocrinol. 2026 Mar 4;194(3):299-306. doi: 10.1093/ejendo/lvag032.
PubMed 41701620
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea, Circulation and Metabolism in Acromegaly - Before and After Treatment
- ClinicalTrials.gov ID
- NCT03431727
- Acronym / sponsor ID
- 1-10-72-126-16
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate sleep apnea, circulation and metabolism in acromegaly before and after surgery and/or medical treatment.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed acromegalic patients
Key inclusion criteria (3 listed)
- Recently diagnosed with acromegaly
- Age above 18
- Written consent
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Circulation
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Sphygmocor: central arterial pressure and pulse wave velocity
Bone metabolism
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
HRpQCT scan
6 secondary outcomes
Heartfunction
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Substrate metabolism; signaling proteins
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Substrate metabolism; gene targets
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Energy expenditure
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Body composition
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Physical activity
Time frame: At baseline (time of diagnosis) and at an average of 1 years treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Derived from this study: PubMed 41701620Baek A, Christiansen Arlien-Soborg M, Pedersen AKN, Dal J, Madsen MA, Hogild ML, Berryman D, Kopchick JJ, Pedersen SB, Bjerre M, Lebeck J, Jessen N, Jorgensen JOL. Growth hormone causes reversible fibrosis in muscle and fat: a study in patients with acromegaly. Eur J Endocrinol. 2026 Mar 4;194(3):299-306. doi: 10.1093/ejendo/lvag032.
- Individual participant dataSharing planned: No
Related trials for Acromegaly
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A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Otto L Jørgensen, Porfessor principal investigator
Aarhus University Hospital, Department of internal medicine and endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly and Growth Hormone Treatment, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai C Arlien-Søborg, MD (+45 23837420, mas@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep apnea (time frame: At baseline (time of diagnosis) and at an average of 1 years treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.