search
Back to results

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

Primary Purpose

Acromegaly Due to Pituitary Adenoma

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP-A
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acromegaly Due to Pituitary Adenoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Biomedical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

GIP-A

Placebo

Arm Description

Infusion of GIP-A alone as a study tool.

Saline

Outcomes

Primary Outcome Measures

Growth hormone levels
Plasma growth hormone area under the curve (AUC)

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2019
Last Updated
May 27, 2023
Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Herlev and Gentofte Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03807076
Brief Title
Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor
Acronym
GA-9
Official Title
Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly Due to Pituitary Adenoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GIP-A
Arm Type
Other
Arm Description
Infusion of GIP-A alone as a study tool.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Other
Intervention Name(s)
GIP-A
Intervention Description
GIP-A
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Growth hormone levels
Description
Plasma growth hormone area under the curve (AUC)
Time Frame
240 min
Secondary Outcome Measure Information:
Title
Glucose levels
Description
Plasma glucose AUC
Time Frame
240 min
Title
GIP levels
Description
Plasma GIP AUC
Time Frame
240 min
Title
Insulin levels
Description
Serum insulin AUC
Time Frame
240 min
Title
C-peptide levels
Description
Serum C-peptide AUC
Time Frame
240 min
Title
Insulin-like growth factor-1 (IGF-1) levels
Description
Plasma IGF-1 AUC
Time Frame
240 min
Title
Free fatty acids (FFA) levels
Description
serum FFA AUC
Time Frame
240 min
Title
Glucagon levels
Description
plasma glucagon AUC
Time Frame
240 min
Title
Ghrelin levels
Description
plasma ghrelin AUC
Time Frame
240 min
Title
GLP-1 levels
Description
Plasma GLP-1 AUC
Time Frame
240 min
Title
GLP-2 levels
Description
Plasma GLP-2 AUC
Time Frame
240 min
Title
Plasma cholesterol
Description
Plasma cholesterol AUC
Time Frame
240 min
Title
Plasma triglyceride
Description
Plasma triglyceride AUC
Time Frame
240 min
Title
Plasma TSH
Description
Plasma TSH AUC
Time Frame
240 min
Title
Plasma prolactin
Description
Plasma prolactin AUC
Time Frame
240 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette H Jensen, MSc
Organizational Affiliation
Department of Biomedical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Sciences
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs