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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 : August 6, 2021
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg University Hospital
Odense University Hospital
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Mette Høy Jensen, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date August 6, 2021
Actual Study Start Date  ICMJE August 13, 2019
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2021)
Growth hormone levels [ Time Frame: 240 min ]
Plasma growth hormone area under the curve (AUC)
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Growth hormone levels [ Time Frame: 210 min ]
Plasma growth hormone AUC
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Glucose levels [ Time Frame: 210 min ]
    Plasma glucose AUC
  • GIP levels [ Time Frame: 210 min ]
    Plasma GIP AUC
  • Insulin levels [ Time Frame: 210 min ]
    Serum insulin AUC
  • C-peptide levels [ Time Frame: 210 min ]
    Serum C-peptide AUC
  • IGF-1 levels [ Time Frame: 210 min ]
    Plasma IGF-1 AUC
  • FFA levels [ Time Frame: 210 min ]
    serum FFA AUC
  • Glucagon levels [ Time Frame: 210 min ]
    plasma glucagon AUC
  • Ghrelin levels [ Time Frame: 210 min ]
    plasma ghrelin AUC
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor
Official Title  ICMJE Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Acromegaly Due to Pituitary Adenoma
Intervention  ICMJE
  • Other: GIP-A
    GIP-A
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • GIP-A
    Infusion of GIP-A alone as a study tool.
    Intervention: Other: GIP-A
  • Placebo Comparator: Placebo
    Saline
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mette H Jensen, MSc 29671572 ext +45 mette.jakobsen@sund.ku.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03807076
Other Study ID Numbers  ICMJE Acromegaly GA-9
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mette Høy Jensen, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • Aarhus University Hospital
  • Aalborg University Hospital
  • Odense University Hospital
  • Herlev and Gentofte Hospital
Investigators  ICMJE
Principal Investigator: Mette H Jensen, MSc Department of Biomedical Sciences
PRS Account University of Copenhagen
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP