Clinical trial NCT03807076: Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor
Official title: Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly Due to Pituitary Adenoma
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Odense University Hospital
name: Herlev and Gentofte Hospital
First posted: 2019-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Growth hormone levels
timeFrame: 240 min
Secondary outcomes:
measure: Glucose levels
timeFrame: 240 min
measure: GIP levels
timeFrame: 240 min
measure: Insulin levels
timeFrame: 240 min
measure: C-peptide levels
timeFrame: 240 min
measure: Insulin-like growth factor-1 (IGF-1) levels
timeFrame: 240 min
measure: Free fatty acids (FFA) levels
timeFrame: 240 min
measure: Glucagon levels
timeFrame: 240 min
measure: Ghrelin levels
timeFrame: 240 min
measure: GLP-1 levels
timeFrame: 240 min
measure: GLP-2 levels
timeFrame: 240 min
measure: Plasma cholesterol
timeFrame: 240 min
measure: Plasma triglyceride
timeFrame: 240 min
measure: Plasma TSH
timeFrame: 240 min
measure: Plasma prolactin
timeFrame: 240 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Biomedical Sciences
Study officials:
affiliation: Department of Biomedical Sciences
name: Mette H Jensen, MSc
role: PRINCIPAL_INVESTIGATOR
References: