Brief Title
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients
Official Title
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
Brief Summary
The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy. Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.
Study Type
Interventional
Primary Outcome
Insulin sensitivity
Secondary Outcome
Glucose tolerance
Condition
Acromegaly
Intervention
Pegvisomant
Study Arms / Comparison Groups
1
Description: Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
June 2008
Completion Date
May 2011
Primary Completion Date
November 2009
Eligibility Criteria
Inclusion Criteria: - Age > 18 - Diagnosed with acromegaly - Safe anticonceptive for fertile women - Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH < 0.5 µg/l.) Exclusion Criteria: - Pregnancy - Liver disease - Diabetes mellitus type I - Magnetic or electronic implants
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jens Otto L. Jørgensen, MD Professor, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00652379
Organization ID
GH-2007-228
Secondary IDs
2007-005244-25
Responsible Party
Sponsor
Study Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital Skejby
Study Sponsor
Jens Otto L. Jørgensen, MD Professor, Principal Investigator, Aarhus University Hospital
Verification Date
January 2012