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

Acromegaly Due to Pituitary Adenoma Clinical Trial

— GA-9  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807076
• Other study ID #: Acromegaly GA-9
• Status: Completed
• Phase: N/A
• Start date: August 13, 2019
• Est. completion date: November 28, 2023

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 28, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly
• Acromegaly Due to Pituitary Adenoma
• Adenoma
• Growth Hormone-Secreting Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Other:
• GIP-A
GIP-A
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Department of Biomedical Sciences	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
University of Copenhagen	Aalborg University Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth hormone levels	Plasma growth hormone area under the curve (AUC)	240 min
Secondary	Glucose levels	Plasma glucose AUC	240 min
Secondary	GIP levels	Plasma GIP AUC	240 min
Secondary	Insulin levels	Serum insulin AUC	240 min
Secondary	C-peptide levels	Serum C-peptide AUC	240 min
Secondary	Insulin-like growth factor-1 (IGF-1) levels	Plasma IGF-1 AUC	240 min
Secondary	Free fatty acids (FFA) levels	serum FFA AUC	240 min
Secondary	Glucagon levels	plasma glucagon AUC	240 min
Secondary	Ghrelin levels	plasma ghrelin AUC	240 min
Secondary	GLP-1 levels	Plasma GLP-1 AUC	240 min
Secondary	GLP-2 levels	Plasma GLP-2 AUC	240 min
Secondary	Plasma cholesterol	Plasma cholesterol AUC	240 min
Secondary	Plasma triglyceride	Plasma triglyceride AUC	240 min
Secondary	Plasma TSH	Plasma TSH AUC	240 min
Secondary	Plasma prolactin	Plasma prolactin AUC	240 min