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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Odense University Hospital |
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Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIP-A | Other | Infusion of GIP-A alone as a study tool. |
|
| Placebo | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIP-A | Other | GIP-A |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Growth hormone levels | Plasma growth hormone area under the curve (AUC) | 240 min |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose levels | Plasma glucose AUC | 240 min |
| GIP levels | Plasma GIP AUC | 240 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette H Jensen, MSc | Department of Biomedical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biomedical Sciences | Copenhagen | 2200 | Denmark |
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| ID | Term |
|---|---|
| D049912 | Growth Hormone-Secreting Pituitary Adenoma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
| Herlev and Gentofte Hospital | OTHER |
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| Other |
Placebo |
|
| Insulin levels | Serum insulin AUC | 240 min |
| C-peptide levels | Serum C-peptide AUC | 240 min |
| Insulin-like growth factor-1 (IGF-1) levels | Plasma IGF-1 AUC | 240 min |
| Free fatty acids (FFA) levels | serum FFA AUC | 240 min |
| Glucagon levels | plasma glucagon AUC | 240 min |
| Ghrelin levels | plasma ghrelin AUC | 240 min |
| GLP-1 levels | Plasma GLP-1 AUC | 240 min |
| GLP-2 levels | Plasma GLP-2 AUC | 240 min |
| Plasma cholesterol | Plasma cholesterol AUC | 240 min |
| Plasma triglyceride | Plasma triglyceride AUC | 240 min |
| Plasma TSH | Plasma TSH AUC | 240 min |
| Plasma prolactin | Plasma prolactin AUC | 240 min |
| D010911 |
| Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |