Back to resultsSomatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Primary Purpose
Acromegaly, Metabolic Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
genotropin
Sponsored by
About this trial
This is an interventional basic science trial for Acromegaly focused on measuring Acromegaly, Somatostatin treatment, metabolic effect
Eligibility Criteria
Inclusion Criteria:
- > 18 years
- treated acromegaly
- considered suitable
Exclusion Criteria:
- pregnancy
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
surgery treated
SA treated
Arm Description
10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin
10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01723748
Brief Title
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Official Title
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Metabolic Diseases
Keywords
Acromegaly, Somatostatin treatment, metabolic effect
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery treated
Arm Type
Active Comparator
Arm Description
10 patients with well-controlled acromegaly for at least 6 months after surgery alone.
Stimulated with genotropin
Arm Title
SA treated
Arm Type
Active Comparator
Arm Description
10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin
Intervention Type
Drug
Intervention Name(s)
genotropin
Other Intervention Name(s)
growth hormone
Intervention Description
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
Primary Outcome Measure Information:
Title
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
Description
GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I
Description
GH (ug/l), IGF-l (ug/l), bioactive IGF-l (ug/l)
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
GH, and insulin signal transduction in muscle and fat biopsies and regulation of lipolysis.
Description
By western blot technique protien levels of (arbitrary densitomety units) AKT, pAKT threonin, pAKT serine, STAT5, pSTAT5, PTEN, p85alpha, mTOR, pmTOR.
By PCR technique (relative nRNA expression) mRNA levels of IGF-1, SOCS1, SOCS2, SOCS3, CISH, PTEN, Pik3r
Time Frame
3 years
Title
patient characterization
Description
sex (M/F), age (year), disease duration (years), BMI (kg/m2)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
> 18 years
treated acromegaly
considered suitable
Exclusion Criteria:
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Joergensen, professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
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