Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Study Overview
=================
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

Official Title
-----------------
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Conditions
-----------------
Acromegaly, Metabolic Diseases

Intervention / Treatment
-----------------
* Drug: genotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years treated acromegaly considered suitable Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery treated<br>10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin | Drug: genotropin<br>* iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.<br>* Other names: growth hormone;|
| Active Comparator: SA treated<br>10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin | Drug: genotropin<br>* iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.<br>* Other names: growth hormone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly, Somatostatin treatment, metabolic effect