Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

Not Applicable

Completed

• Conditions: Acromegaly; Insulin Resistance; Impaired Glucose Tolerance
• Interventions: Drug: Pegvisomant; Drug: Somatostatin analog (lanreotide or octreotide)

• Registration Number: NCT00652379
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Study Start: 2008-06
• Primary Completion: 2009-11
• Study Completion: 2011-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pegvisomant	Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
1	Somatostatin analog (lanreotide or octreotide)	Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
2	Somatostatin analog (lanreotide or octreotide)	Somatostatin analog, unaltered dosage

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	0 and after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance	0 and after 24 weeks
Symptoms, QoL questionaire	0, 12 and 24 weeks
Intrahepatic and intramyocellular fat	0 and 24 weeks
Substrate metabolism	0 and 24 weeks

Trial Locations

Locations (1)

Department of Endocrinology, Aarhus University Hospital; 🇩🇰 Aarhus C, Aarhus, Denmark