Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor (GA-9)

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

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

Study Overview

• Status: Completed
• Conditions: Acromegaly Due to Pituitary Adenoma
• Intervention / Treatment: Other: Placebo; Other: GIP-A

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Department of Biomedical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline	Other: Placebo; Placebo
Other: GIP-A; Infusion of GIP-A alone as a study tool.	Other: GIP-A; GIP-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth hormone levels	Plasma growth hormone area under the curve (AUC)	240 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Odense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Aalborg University Hospital; Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Mette H Jensen, MSc, Department of Biomedical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Musculoskeletal Diseases; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Adenoma; Pituitary Neoplasms; Pituitary Diseases; Acromegaly; Growth Hormone-Secreting Pituitary Adenoma
• Other Study ID Numbers: Acromegaly GA-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No