Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807076
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : May 21, 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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma

Condition or disease Intervention/treatment Phase
Acromegaly Due to Pituitary Adenoma Other: GIP-A Other: Placebo Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
GIP-A
Infusion of GIP-A alone as a study tool.
 Other: GIP-A
GIP-A
Placebo Comparator: Placebo
Saline
 Other: Placebo
Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Growth hormone levels [ Time Frame: 240 min ]
    Plasma growth hormone area under the curve (AUC)


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Mette H Jensen, MSc 29671572 ext +45 mette.jakobsen@sund.ku.dk

Locations
Layout table for location information
Denmark
Biomedical Institute Recruiting
Copenhagen, Denmark, 2200
Contact: Mette H Jensen, MSc    29671572 ext +45    mette.jakobsen@sund.ku.dk   
Sponsors and Collaborators
University of Copenhagen
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg University Hospital
Odense University Hospital
Herlev and Gentofte Hospital
Investigators
Layout table for investigator information
Principal Investigator: Mette H Jensen, MSc Biomedical Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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