The Effect of Lixisenatide on the Effect of Pituitary Hormones
NCT ID: NCT05804513
Last Updated: 2023-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
10 participants
INTERVENTIONAL
2023-04-17
2023-12-31
Brief Summary
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1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test;
2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose.
The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).
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Detailed Description
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All study subjects receive once a placebo and once 10 micrograms of lixisenatide.
The order of administration of study medication is decided on randomization. The placebo and lixisenatide are administered at least 2 days apart.
Blood samples are taken 30 minutes and immediately before study medication administration and 30, 60, 90, 120, and 150 minutes after study medication administration,.
The primary endpoint is the peak value of growth hormone measured during the 2,5 hours after study medication administration.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Placebo, healthy volunteers
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Placebo
s/c injection
Lixisenatide 10 micrograms, healthy volunteers
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
s/c injection
Placebo, type 1 diabetic patients
Sodium chloride 0.9% solution. Subcutaneous injection administered once.
Placebo
s/c injection
Lixisenatide 10 micrograms, type 1 diabetic patients
Lixisenatide 10 micrograms. Subcutaneous injection administered once.
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
s/c injection
Interventions
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Placebo
s/c injection
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
s/c injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* male sex
* age 18-60 years
* body weight \> 65 kg
2. Patients with type 1 diabetes:
* type 1 diabetes
* male sex
* age 18-60 years
* body weight \> 65 kg
* c-peptide in fasting blood sample \<0,1 nmol/l
* HbA1c \< 8,5%
Exclusion Criteria
* use of aldosterone antagonist
* use of glucocorticosteroid
* use of other medication that potentially significantly affects pituitary function.
2. Patients with type 1 diabetes:
* use of aldosterone antagonist
* use of glucocorticosteroid
* use of other medication that potentially significantly affects pituitary function.
* The patient is excluded from the study if a significant change in blood glucose occurs in the study center.
18 Years
60 Years
MALE
Yes
Sponsors
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Tartu University Hospital
OTHER
University of Tartu
OTHER
Responsible Party
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Vallo Volke
professor
Principal Investigators
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Vallo Volke, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tartu, Tartu University Hosptial
Locations
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Tartu University Hospital
Tartu, , Estonia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Lixi22
Identifier Type: -
Identifier Source: org_study_id
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