Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Not Applicable

Completed

• Conditions: Metabolic Diseases; Acromegaly
• Interventions: Drug: genotropin

• Registration Number: NCT01723748
• Lead Sponsor: University of Aarhus

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 Timeline

• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-08
• Study Start: 2012-12
• Status Verified: 2014-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• > 18 years
• treated acromegaly
• considered suitable

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery treated	genotropin	10 patients with well-controlled acromegaly for at least 6 months after surgery alone. Stimulated with genotropin
SA treated	genotropin	10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin

Primary Outcome Measures

Name	Time	Method
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)	3 years	GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)

Secondary Outcome Measures

Name	Time	Method
concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I	3 years	GH (ug/l), IGF-l (ug/l), bioactive IGF-l (ug/l)

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark