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| ID | Type | Description | Link |
|---|---|---|---|
| 35197 | Other Identifier | VEK |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery treated | Active Comparator | 10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin |
|
| SA treated | Active Comparator | 10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genotropin | Drug | iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GH, and insulin signal transduction in muscle and fat biopsies and regulation of lipolysis. | 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 | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Otto L Joergensen, professor | Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| patient characterization | sex (M/F), age (year), disease duration (years), BMI (kg/m2) | 3 years |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |