CClinicalTrials.gg
Sign In
CompletedNCT03807076GA-9Updated Nov 29, 2023

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

An interventional study of GIP-A and Placebo in Acromegaly Due to Pituitary Adenoma, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma

Read the 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

02

Conditions studied

  • Acromegaly Due to Pituitary Adenoma
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

Exclusion Criteria:

  • Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (>170/100 mmHg), current pregnancy
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    GIP-A

    Infusion of GIP-A alone as a study tool.

    Other: GIP-A

  • Placebo comparator
    Placebo

    Saline

    Other: Placebo

Interventions

  • OtherGIP-A

    GIP-A

  • OtherPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. Growth hormone levels

    Plasma growth hormone area under the curve (AUC)

    Time frame: 240 min

Secondary outcomes

  1. Glucose levels

    Plasma glucose AUC

    Time frame: 240 min

  2. GIP levels

    Plasma GIP AUC

    Time frame: 240 min

  3. Insulin levels

    Serum insulin AUC

    Time frame: 240 min

  4. C-peptide levels

    Serum C-peptide AUC

    Time frame: 240 min

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

    Plasma IGF-1 AUC

    Time frame: 240 min

  6. Free fatty acids (FFA) levels

    serum FFA AUC

    Time frame: 240 min

  7. Glucagon levels

    plasma glucagon AUC

    Time frame: 240 min

  8. Ghrelin levels

    plasma ghrelin AUC

    Time frame: 240 min

  9. GLP-1 levels

    Plasma GLP-1 AUC

    Time frame: 240 min

  10. GLP-2 levels

    Plasma GLP-2 AUC

    Time frame: 240 min

  11. Plasma cholesterol

    Plasma cholesterol AUC

    Time frame: 240 min

  12. Plasma triglyceride

    Plasma triglyceride AUC

    Time frame: 240 min

  13. Plasma TSH

    Plasma TSH AUC

    Time frame: 240 min

  14. Plasma prolactin

    Plasma prolactin AUC

    Time frame: 240 min

06

Study locations

1 site
  • Department of Biomedical Sciences
    Copenhagen, 2200, Denmark
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03807076
Lead sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Herlev and Gentofte Hospital
Responsible party
Mette Høy Jensen (Industrial PhD student, University of Copenhagen) — Principal investigator
First posted
Jan 16, 2019
Start date
Aug 13, 2019
Primary completion
Jun 14, 2023
Completion
Nov 28, 2023
Last update
Nov 29, 2023

Study contacts

Mette H Jensen, MSc
principal investigator · Department of Biomedical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Adenoma→

Other studies from this sponsor

University of Copenhagen

Start the discussion