Clinical trial NCT05804513: The Effect of Lixisenatide on the Effect of Pituitary Hormones
Official title: The Effect of Lixisenatide on the Effect of Pituitary Hormones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Type 1 Diabetes
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Tartu University Hospital
First posted: 2023-04-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Blinded randomised two group crossover
Primary purpose: DIAGNOSTIC

Brief 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).

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.

Eligibility 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
   * 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.

Primary outcomes:
measure: Growth hormone area under the curve.
timeFrame: 0-150 minutes after study drug administration
Secondary outcomes:
measure: Growth hormone peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration.
measure: Glucose nadir
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: C-peptide peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Cortisol peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Adrenocorticotropic hormone (ACTH) peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Prolactin peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Copeptin peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Aldosterone peak
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
Other outcomes:
measure: Nausea
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Systolic and diastolic blood pressure
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration
measure: Heart rate
timeFrame: 30, 60, 90, 120, and 150 minutes after the study drug administration.
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: University of Tartu, Tartu University Hosptial
name: Vallo Volke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: