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

University of Aarhus18 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly Insulin Resistance Impaired Glucose Tolerance

Interventions

PegvisomantDRUG

Pegvisomant s.c 15-30 mg 2 times a week

Somatostatin analog (lanreotide or octreotide)DRUG

Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Endocrinology, Aarhus University Hospital

Aarhus C, Aarhus, Denmark

Outcomes

Primary Outcomes

Insulin sensitivity

Time frame: 0 and after 24 weeks

Secondary Outcomes

Glucose tolerance

Time frame: 0 and after 24 weeks

Symptoms, QoL questionaire

Time frame: 0, 12 and 24 weeks

Intrahepatic and intramyocellular fat

Time frame: 0 and 24 weeks

Substrate metabolism

Time frame: 0 and 24 weeks

Data from ClinicalTrials.gov

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