Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
2 other identifiers
interventional
18
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
November 8, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedApril 5, 2016
December 1, 2014
2.4 years
November 6, 2012
April 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
3 years
Secondary Outcomes (1)
concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I
3 years
Other Outcomes (2)
GH, and insulin signal transduction in muscle and fat biopsies and regulation of lipolysis.
3 years
patient characterization
3 years
Study Arms (2)
surgery treated
ACTIVE COMPARATOR10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin
SA treated
ACTIVE COMPARATOR10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin
Interventions
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
Eligibility Criteria
You may qualify if:
- \> 18 years
- treated acromegaly
- considered suitable
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, Aarhus, 8000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jens Otto L Joergensen, professor
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2012
First Posted
November 8, 2012
Study Start
December 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 5, 2016
Record last verified: 2014-12
Data Sharing
- IPD Sharing
- Will not share