AcromegalyNCT00647179
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
An observational study of Acromegaly and Excessive Growth Hormone Secretion, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acromegaly, Excessive Growth Hormone Secretion, Insulin Resistance
- What is being tested?
- Transsphenoidal adenomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to 7 Dec 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patiens recently diagnoses with acromegaly, recruited from the clinic
Who may be able to join
- Written consent
- Age between 18 and 70
- Recently diagnosed with acromegaly
Who cannot join
- NYHA 3
- Uncontrolled hypertension
- Known cerebrovascular disease
- Proliferative retinopatia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Aarhus, DK-8000
About this study
The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.
- Being tested
- Transsphenoidal adenomectomy
- Keywords
- Acromegaly, Growth Hormone, Insulin resistance, Glucose tolerance, Body Composition, Substrate metabolism
- Medical subject headings
- Acromegaly, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transsphenoidal adenomectomyProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients recently diagnosed with acromegaly Receives: Procedure: Transsphenoidal adenomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: Before and after treatment
Secondary outcomes (1)
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance
Measured: Before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completion7 Dec 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Otto L. Jørgensen, Professor MD, Principal investigator, Aarhus University Hospital, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647179
- Sponsor's protocol ID
- MM-ISA-20070130
- Other IDs
- M-20070130
- Status last verified
- Dec 2017
- First submitted
- 26 Mar 2008
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- 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 41701620Arlien-Soborg MC, Grondahl C, Baek A, Dal J, Madsen M, Hogild ML, Pedersen SB, Bjerre M, Jorgensen JOL. Fibroblast Activation Protein is a GH Target: A Prospective Study of Patients with Acromegaly Before and After Treatment. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz033. doi: 10.1210/clinem/dgz033.
PubMed 31544947
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
- ClinicalTrials.gov ID
- NCT00647179
- Acronym / sponsor ID
- MM-ISA-20070130
- Keywords
- Acromegaly, Growth Hormone, Insulin resistance, Glucose tolerance, Body Composition, Substrate metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Feb 2008
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 31 Mar 2008 (estimated)
- 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 purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Transsphenoidal adenomectomyPatients recently diagnosed with acromegaly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiens recently diagnoses with acromegaly, recruited from the clinic
Key inclusion criteria (3 listed)
- Written consent
- Age between 18 and 70
- Recently diagnosed with acromegaly
Key exclusion criteria (4 listed)
- NYHA 3
- Uncontrolled hypertension
- Known cerebrovascular disease
- Proliferative retinopatia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transsphenoidal adenomectomySurgery | Procedure or surgery | 1 |
Primary outcome
Insulin sensitivity
Time frame: Before and after treatment
1 secondary outcome
QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance
Time frame: Before and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- 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.
- Derived from this study: PubMed 31544947Arlien-Soborg MC, Grondahl C, Baek A, Dal J, Madsen M, Hogild ML, Pedersen SB, Bjerre M, Jorgensen JOL. Fibroblast Activation Protein is a GH Target: A Prospective Study of Patients with Acromegaly Before and After Treatment. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz033. doi: 10.1210/clinem/dgz033.
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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, Professor MD principal investigator
Aarhus University Hospital, Department of 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 Excessive Growth Hormone Secretion, 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 4 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: finished, as of the sponsor's last update on 26 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Before and after treatment). 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 NCT00647179, which also lists 2 linked publications.
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 26 Dec 2017.