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

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University of Copenhagen

Status

Completed

Conditions

Acromegaly Due to Pituitary Adenoma

Treatments

Other: GIP-A
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03807076
Acromegaly GA-9

Details and patient eligibility

About

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

Full 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

Enrollment

25 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 2 patient groups, including a placebo group

GIP-A
Other group
Description:
Infusion of GIP-A alone as a study tool.
Treatment:
Other: GIP-A
Placebo
Placebo Comparator group
Description:
Saline
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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