Effect of Exenatide on Cortisol Secretion

Healthy Clinical Trial

Official title:

Effect of Exenatide on Cortisol Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160261
• Other study ID #: Ex17
• Status: Completed
• Phase: Phase 4
• Start date: September 7, 2017
• Est. completion date: December 28, 2017

Study information

• Verified date: May 2018
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.

Description:

Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.

The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.

The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18-50 years

• Body weight >65 kg

Exclusion Criteria:

• Presence of chronic illness

• daily use of any medicines

• pregnancy, lactation

• use of oral contraceptives during previous 2 months

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Exenatide Injection
Single injection of Exenatide 10µg subcutaneously

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate	Change in heart rate	every 30 minutes during 2 hours after injection
Other	Blood pressure	Change in blood pressure	every 30 minutes during 2 hours after injection
Other	nausea	intensity of nausea in visual analogue scale	every 30 minutes during 2 hours after injection
Primary	Cortisol peak	Maximum concentration achieved after exenatide dose (any timepoint after injection)	every 30 minutes during 2 hours after injection
Secondary	Adrenocorticotropin (ACTH) peak	Maximum concentration achieved after exenatide dose (any timepoint after injection)	every 30 minutes during 2 hours after injection
Secondary	Glucose	Glucose values' area under the curve	Glucose measured every 30 minutes during 2 hours after injection
Secondary	Growth hormone	Maximum concentration achieved after exenatide dose (any timepoint after injection)	every 30 minutes during 2 hours after injection