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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807076
Acronym
GA-9
Enrollment
25
Registered
2019-01-16
Start date
2019-08-13
Completion date
2023-11-28
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly Due to Pituitary Adenoma

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

Interventions

OTHERGIP-A

GIP-A

OTHERPlacebo

Placebo

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Herlev and Gentofte Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Growth hormone levels240 minPlasma growth hormone area under the curve (AUC)

Secondary

MeasureTime frameDescription
GIP levels240 minPlasma GIP AUC
Insulin levels240 minSerum insulin AUC
C-peptide levels240 minSerum C-peptide AUC
Insulin-like growth factor-1 (IGF-1) levels240 minPlasma IGF-1 AUC
Free fatty acids (FFA) levels240 minserum FFA AUC
Glucagon levels240 minplasma glucagon AUC
Glucose levels240 minPlasma glucose AUC
GLP-1 levels240 minPlasma GLP-1 AUC
GLP-2 levels240 minPlasma GLP-2 AUC
Plasma cholesterol240 minPlasma cholesterol AUC
Plasma triglyceride240 minPlasma triglyceride AUC
Plasma TSH240 minPlasma TSH AUC
Plasma prolactin240 minPlasma prolactin AUC
Ghrelin levels240 minplasma ghrelin AUC

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026