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Completed

NCT Number: NCT03807076

Modulating the 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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIP-A

Other

GIP-A

Placebo

Other

Placebo

Primary outcomes

  1. Growth hormone levels

    Time frame: 240 min

    Plasma growth hormone area under the curve (AUC)

Secondary outcomes

  1. Glucose levels

    Time frame: 240 min

    Plasma glucose AUC

  2. GIP levels

    Time frame: 240 min

    Plasma GIP AUC

  3. Insulin levels

    Time frame: 240 min

    Serum insulin AUC

  4. C-peptide levels

    Time frame: 240 min

    Serum C-peptide AUC

  5. Insulin-like growth factor-1 (IGF-1) levels

    Time frame: 240 min

    Plasma IGF-1 AUC

  6. Free fatty acids (FFA) levels

    Time frame: 240 min

    serum FFA AUC

  7. Glucagon levels

    Time frame: 240 min

    plasma glucagon AUC

  8. Ghrelin levels

    Time frame: 240 min

    plasma ghrelin AUC

  9. GLP-1 levels

    Time frame: 240 min

    Plasma GLP-1 AUC

  10. GLP-2 levels

    Time frame: 240 min

    Plasma GLP-2 AUC

  11. Plasma cholesterol

    Time frame: 240 min

    Plasma cholesterol AUC

  12. Plasma triglyceride

    Time frame: 240 min

    Plasma triglyceride AUC

  13. Plasma TSH

    Time frame: 240 min

    Plasma TSH AUC

  14. Plasma prolactin

    Time frame: 240 min

    Plasma prolactin AUC

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Herlev and Gentofte Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Acronym: GA-9

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 16, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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