Department of Biomedical Sciences
Copenhagen, 2200, Denmark
NCT Number: NCT03807076
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Copenhagen, 2200, Denmark
Aim: To determine the importance of the GIP system in patients with acromegaly who has paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP antagonist (GIP-A).
Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin levels will be included in a placebo-controlled cross-over study. The study consists of two study days with concomitant infusions of A) GIP-A or B) saline (placebo).
A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the literature.
Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J Clin Endocrinol Metab 104(3), 856-862
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GIP-A
Placebo
Time frame: 240 min
Plasma growth hormone area under the curve (AUC)
Time frame: 240 min
Plasma glucose AUC
Time frame: 240 min
Plasma GIP AUC
Time frame: 240 min
Serum insulin AUC
Time frame: 240 min
Serum C-peptide AUC
Time frame: 240 min
Plasma IGF-1 AUC
Time frame: 240 min
serum FFA AUC
Time frame: 240 min
plasma glucagon AUC
Time frame: 240 min
plasma ghrelin AUC
Time frame: 240 min
Plasma GLP-1 AUC
Time frame: 240 min
Plasma GLP-2 AUC
Time frame: 240 min
Plasma cholesterol AUC
Time frame: 240 min
Plasma triglyceride AUC
Time frame: 240 min
Plasma TSH AUC
Time frame: 240 min
Plasma prolactin AUC
University of Copenhagen
Other
Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
Acronym: GA-9
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