Brief Title
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Official Title
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Brief 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. 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 Type
Interventional
Primary Outcome
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
Secondary Outcome
concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I
Condition
Acromegaly
Intervention
genotropin
Study Arms / Comparison Groups
surgery treated
Description: 10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
December 2012
Completion Date
May 2015
Primary Completion Date
May 2015
Eligibility Criteria
Inclusion Criteria:
- > 18 years
- treated acromegaly
- considered suitable
Exclusion Criteria:
- pregnancy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jens Otto L Joergensen, professor, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT01723748
Organization ID
1-10-72-491-12
Secondary IDs
35197
Responsible Party
Sponsor
Study Sponsor
University of Aarhus
Study Sponsor
Jens Otto L Joergensen, professor, Study Director, Aarhus University Hospital
Verification Date
December 2014