NCT03807076

Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor

Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma

Detailed description

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

Conditions

• Acromegaly Due to Pituitary Adenoma

Interventions

Type	Name	Description
OTHER	GIP-A	GIP-A
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-08-13
• Primary completion: 2023-06-14
• Completion: 2023-11-28
• First posted: 2019-01-16
• Last updated: 2023-11-29

Locations

1 site across 1 country: Denmark