Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Acromegaly Clinical Trial

Official title:

Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723748
• Other study ID #: 1-10-72-491-12
• Secondary ID: 35197
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: April 4, 2016
• Start date: December 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• treated acromegaly

• considered suitable

Exclusion Criteria:

• pregnancy

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acromegaly
• Metabolic Diseases

Intervention

Drug:
• genotropin
iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	patient characterization	sex (M/F), age (year), disease duration (years), BMI (kg/m2)	3 years	No
Primary	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	No
Secondary	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	No