The Effect of Lixisenatide on the Effect of Pituitary Hormones

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Tartu
• Collaborator: Tartu University Hospital
• Treatments: Lixisenatide

Criteria

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, glucocorticosteroid, or other medication that potentially significantly affects pituitary function.

2. Patients with type 1 diabetes:

Use of aldosterone antagonist, glucocorticosteroid, or other medication that potentially significantly affects pituitary function. The patient is excluded from the study if a significant change in blood glucose occursin the study center.