The Effect of Lixisenatide on the Effect of Pituitary Hormones

Healthy Clinical Trial

Official title:

The Effect of Lixisenatide on the Effect of Pituitary Hormones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804513
• Other study ID #: Lixi22
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: University of Tartu
• Contact: Vallo Volke, MD, PhD
• Phone: 7374330
• Email: vallo.volke[@]ut.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Healthy
• Pituitary Diseases
• Type 1 Diabetes

Intervention

Drug:
• Placebo
s/c injection
• Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
s/c injection

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea	The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea.	30, 60, 90, 120, and 150 minutes after the study drug administration
Other	Systolic and diastolic blood pressure	The change in systolic and diastolic blood pressure compared to baseline.	30, 60, 90, 120, and 150 minutes after the study drug administration
Other	Heart rate	The change in heart rate compared to baseline.	30, 60, 90, 120, and 150 minutes after the study drug administration.
Primary	Growth hormone area under the curve.	Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers.	0-150 minutes after study drug administration
Secondary	Growth hormone peak	Maximum growth hormone concentration measured after study drug administration.	30, 60, 90, 120, and 150 minutes after the study drug administration.
Secondary	Glucose nadir	Lowest glucose concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration
Secondary	C-peptide peak	Maximum c-peptide concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration
Secondary	Cortisol peak	Maximum cortisol concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration
Secondary	Adrenocorticotropic hormone (ACTH) peak	Maximum ACTH concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration
Secondary	Prolactin peak	Maximum prolactin concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration
Secondary	Copeptin peak	Maximum copeptin concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration
Secondary	Aldosterone peak	Maximum aldosterone concentration measured after the study drug administration	30, 60, 90, 120, and 150 minutes after the study drug administration