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

NCT03807076 — Not applicable, Completed, 25 participants, University of Copenhagen

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

Registry	NCT03807076, acronym GA-9
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: none, basic science
Enrollment	25 (Actual)
Sponsor	University of Copenhagen (Other); collaborators: Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Herlev and Gentofte Hospital
Conditions	Acromegaly Due to Pituitary Adenoma
Interventions	GIP-A, Placebo (Other)
Dates	start 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 in Denmark

-Summary

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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
GIP-A	Other	Other: GIP-A	Infusion of GIP-A alone as a study tool.
Placebo	Placebo comparator	Other: Placebo	Saline

GIP-A (Other): GIP-A
Placebo (Other): Placebo

+Outcome measures

Primary outcomes

Growth hormone levels [240 min]: Plasma growth hormone area under the curve (AUC)

Secondary outcomes

Glucose levels [240 min]: Plasma glucose AUC
GIP levels [240 min]: Plasma GIP AUC
Insulin levels [240 min]: Serum insulin AUC
C-peptide levels [240 min]: Serum C-peptide AUC
Insulin-like growth factor-1 (IGF-1) levels [240 min]: Plasma IGF-1 AUC
Free fatty acids (FFA) levels [240 min]: serum FFA AUC
Glucagon levels [240 min]: plasma glucagon AUC
Ghrelin levels [240 min]: plasma ghrelin AUC
GLP-1 levels [240 min]: Plasma GLP-1 AUC
GLP-2 levels [240 min]: Plasma GLP-2 AUC
Plasma cholesterol [240 min]: Plasma cholesterol AUC
Plasma triglyceride [240 min]: Plasma triglyceride AUC
Plasma TSH [240 min]: Plasma TSH AUC
Plasma prolactin [240 min]: Plasma prolactin AUC

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (>170/100 mmHg), current pregnancy

+Locations (1)

Facility	City	Country	Status
Department of Biomedical Sciences	Copenhagen	Denmark

+Investigators

Mette H Jensen, MSc, Principal investigator, Department of Biomedical Sciences

My Notes

Public

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