DRUG
Placebo
s/c injection
The Effect of Lixisenatide on the Effect of Pituitary Hormones
Status
Unknown
Phase
Phase 4
Enrollment
10
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The current study has two aims: 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).
Full detailed description
The randomized, blinded, placebo-controlled clinical trial is conducted on 5 healthy volunteers and 5 patients with type 1 diabetes. 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.
Interventions
Treatment arms and agents.
DRUG
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
s/c injection
Timeline
From registration to results.
First posted
Apr 7, 2023
Study start
Apr 17, 2023
Primary completion
Oct 31, 2023
Study completion
Dec 31, 2023
Results posted
Not reported
Registry updated
Jun 12, 2023
Outcomes
What the study measures.
Primary outcomes
Growth hormone area under the curve.
Time frame · 0-150 minutes after study drug administration
Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers.
Secondary outcomes
Growth hormone peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration.
Maximum growth hormone concentration measured after study drug administration.
Glucose nadir
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Lowest glucose concentration measured after the study drug administration
C-peptide peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Maximum c-peptide concentration measured after the study drug administration
Cortisol peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Maximum cortisol concentration measured after the study drug administration
Adrenocorticotropic hormone (ACTH) peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Maximum ACTH concentration measured after the study drug administration
Prolactin peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Maximum prolactin concentration measured after the study drug administration
Copeptin peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Maximum copeptin concentration measured after the study drug administration
Aldosterone peak
Time frame · 30, 60, 90, 120, and 150 minutes after the study drug administration
Maximum aldosterone concentration measured after the study drug administration
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- MALE
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy volunteers: * 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: 1. Healthy volunteers: * 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.
Study locations
1 registered sites.
Estonia. Showing up to 24 locations stored in the fast local snapshot.
Tartu University Hospital
Tartu, Estonia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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