Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor (GA-9)
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ClinicalTrials.gov Identifier: NCT03807076 |
Recruitment Status :
Recruiting
First Posted : January 16, 2019
Last Update Posted : November 2, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly Due to Pituitary Adenoma | Other: GIP-A Other: Placebo | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor |
Actual Study Start Date : | August 13, 2019 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | July 2023 |

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

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807076
Contact: Mette H Jensen, MSc | 29671572 ext +45 | mette.jakobsen@sund.ku.dk |
Denmark | |
Department of Biomedical Sciences | Recruiting |
Copenhagen, Denmark, 2200 | |
Contact: Mette H Jensen, MSc 29671572 ext +45 mette.jakobsen@sund.ku.dk |
Principal Investigator: | Mette H Jensen, MSc | Department of Biomedical Sciences |
Responsible Party: | Mette Høy Jensen, Industrial PhD student, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT03807076 |
Other Study ID Numbers: |
Acromegaly GA-9 |
First Posted: | January 16, 2019 Key Record Dates |
Last Update Posted: | November 2, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acromegaly Adenoma Pituitary Neoplasms Growth Hormone-Secreting Pituitary Adenoma Pituitary Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Endocrine System Diseases Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Endocrine Gland Neoplasms Neoplasms by Site Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |