Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference. The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Intramuscular injections, dosage based on either GH or IGF-I levels.
Department of Endocrinology, Aarhus University Hospital
Aarhus C, Denmark
Change in Quality of Life
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
Time frame: Baseline and after 12 months
SA dosage
SA dosage at last follow-up
Time frame: After 12 months of treatment
Change in glucose, FFA and insulin
Glucose tolerance during an oral glucose load of 75 gram of glucose
Time frame: Baseline and after 12 months
Change in discordant GH/IGF-I levels
Discordant GH/IGF-I levels are recorded.
Time frame: Baseline and after 12 months
New biomarkers of treatment evaluation
New biomarkers of GH/IGF-I status (bioactive IGF-I)
Time frame: Baseline and after 12 months
New biomarkers of treatment evaluation2
New biomarkers of GH/IGF-I status (free GH)
Time frame: Baseline and after 12 months
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