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

Not Applicable

Completed

• Conditions: Acromegaly Due to Pituitary Adenoma
• Interventions: Other: GIP-A; Other: Placebo

• Registration Number: NCT03807076
• Lead Sponsor: University of Copenhagen

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

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-08-13
• Primary Completion: 2023-06-14
• Status Verified: 2023-11
• Study Completion: 2023-11-28
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP-A	GIP-A	Infusion of GIP-A alone as a study tool.
Placebo	Placebo	Saline

Primary Outcome Measures

Name	Time	Method
Growth hormone levels	240 min	Plasma growth hormone area under the curve (AUC)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Biomedical Sciences; 🇩🇰 Copenhagen, Denmark