AcromegalyNCT01723748
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
A study testing genotropin in people with Acromegaly and Metabolic Diseases, run by University of Aarhus at 1 site in Denmark.
Trial summary
The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acromegaly, Metabolic Diseases
- What is being tested?
- genotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to May 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years
- treated acromegaly
- considered suitable
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough
Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:
- Glucose intolerance despite normalized insulin sensitivity
- Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints
Read the detailed description
Acromegaly is a rare disease usually caused by a benign growth hormone (GH) producing pituitary adenoma. In case of inadequate disease control, the condition is associated with significant morbidity and approximately a doubling of mortality compared to the background population. Medical treatment with somatostatin analogues (SA) has been employed for about 20 years and is a well-established treatment in cases where surgery is impossible or inadequate. The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough
- Conditions
- Acromegaly, Metabolic Diseases
- Being tested
- genotropin
- Keywords
- Acromegaly, Somatostatin treatment, metabolic effect
- Medical subject headings
- Acromegaly, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotropinDrug
Also called growth hormone
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
| Study group | Role | What they receive |
|---|---|---|
| surgery treated | Active comparator | 10 patients with well-controlled acromegaly for at least 6 months after surgery alone.
Stimulated with genotropin Receives: Drug: genotropin |
| SA treated | Active comparator | 10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin Receives: Drug: genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)
Measured: 3 years
Secondary outcomes (1)
concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I
GH (ug/l), IGF-l (ug/l), bioactive IGF-l (ug/l)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Otto L Joergensen, professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723748
- Sponsor's protocol ID
- 1-10-72-491-12
- Other IDs
- 35197
- Status last verified
- Dec 2014
- First submitted
- 6 Nov 2012
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
- ClinicalTrials.gov ID
- NCT01723748
- Acronym / sponsor ID
- 1-10-72-491-12
- Conditions
- Acromegaly, Metabolic Diseases
- Keywords
- Acromegaly, Somatostatin treatment, metabolic effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Nov 2012 (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 treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough
Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:
- Glucose intolerance despite normalized insulin sensitivity
- Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints
Detailed description
Acromegaly is a rare disease usually caused by a benign growth hormone (GH) producing pituitary adenoma. In case of inadequate disease control, the condition is associated with significant morbidity and approximately a doubling of mortality compared to the background population. Medical treatment with somatostatin analogues (SA) has been employed for about 20 years and is a well-established treatment in cases where surgery is impossible or inadequate. The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery treated | Active comparator | Drug: genotropin10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin |
| SA treated | Active comparator | Drug: genotropin10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years
- treated acromegaly
- considered suitable
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genotropinAlso: growth hormoneiii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies. | Drug | SA treated, surgery treated |
Primary outcome
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
Time frame: 3 years
GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)
1 secondary outcome
concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I
Time frame: 3 years
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 5 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Acromegaly
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RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
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 Joergensen, professor study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genotropin in people with Acromegaly and Metabolic Diseases, 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: finished, as of the sponsor's last update on 5 Apr 2016. 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?
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2016.