Acromegaly, Impaired Glucose Tolerance, Insulin Resistance
Conditions
Keywords
Acromegaly, Insulin sensitivity, Glucose tolerance, Body composition, Growth Hormone
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.
Interventions
DRUGPegvisomant
Pegvisomant s.c 15-30 mg 2 times a week
DRUGSomatostatin analog (lanreotide or octreotide)
Study arm 2: usual dosage of a somatostatin analog Study arm 1: half dosage of somatostatin analog
Sponsors
Aarhus University Hospital Skejby
Aarhus University Hospital
The Research Council for Health and Disease, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity | 0 and after 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed