Effect of exenatide on cortisol secretio

Phase 1

Conditions: Healthy volunteers
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2017-001437-12-EE

Lead Sponsor: niversity of Tartu

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Age 18-50 years
2) Bodyweight >65 kg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Existence of chronic disease
2) Existence of drugs used daily
3) Pregnancy, lactation
4) Use of oral contraceptives during two month before the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to test whether exenatide (10 micrograms s.c) stimulates ACTH /cortisol release and what is the magnitude of cortisol response in healthy volunteers. If the response is comparabele to the responses reported during glucagon stimulation test, there is a potential to use the drug to test for secondary adrenal insufficiency.;Secondary Objective: Not applicable;Primary end point(s): Maximum level of cortisol after single exenatide injection;Timepoint(s) of evaluation of this end point: The blood samples for measuring cortisol level are taken before the exenatide injection and 30, 60, 90 and 120 minutes after the administration.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Levels of other related hormonal and biochemical markers and changes in heart rate and blood pressure after exenatide single administration (incl. glucose, ACTH).;Timepoint(s) of evaluation of this end point: The blood samples for measuring hormonal and biochemical markers are taken and blood pressure and heart rate are measured before the exenatide injection and 30, 60, 90 and 120 minutes after the administration.