Department of Endocrinology, Aarhus University Hospital
Aarhus C, 8000, Denmark
NCT Number: NCT01618513
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Aarhus C, 8000, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injections, dosage based on either GH or IGF-I levels.
Time frame: Baseline and after 12 months
AcroQol (Acromegaly Quality of Life Questionnaire) and PASQ (Patient-Assessed Acromegaly Symptom Questionnaire)
Time frame: After 12 months of treatment
SA dosage at last follow-up
Time frame: Baseline and after 12 months
Glucose tolerance during an oral glucose load of 75 gram of glucose
Time frame: Baseline and after 12 months
Discordant GH/IGF-I levels are recorded.
Time frame: Baseline and after 12 months
New biomarkers of GH/IGF-I status (bioactive IGF-I)
Time frame: Baseline and after 12 months
New biomarkers of GH/IGF-I status (free GH)
University of Aarhus
Other
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