Effect of Exenatide on Cortisol Secretion

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03160261

Enrollment

Registered

2017-05-19

Start date

2017-09-07

Completion date

2017-12-28

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Detailed 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.

Interventions

DRUGExenatide Injection

Single injection of Exenatide 10μg subcutaneously

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Single-group, open-label

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cortisol peak	every 30 minutes during 2 hours after injection	Maximum concentration achieved after exenatide dose (any timepoint after injection)

Secondary

Measure	Time frame	Description
Adrenocorticotropin (ACTH) peak	every 30 minutes during 2 hours after injection	Maximum concentration achieved after exenatide dose (any timepoint after injection)
Glucose	Glucose measured every 30 minutes during 2 hours after injection	Glucose values' area under the curve
Growth hormone	every 30 minutes during 2 hours after injection	Maximum concentration achieved after exenatide dose (any timepoint after injection)

Other

Measure	Time frame	Description
nausea	every 30 minutes during 2 hours after injection	intensity of nausea in visual analogue scale
heart rate	every 30 minutes during 2 hours after injection	Change in heart rate
Blood pressure	every 30 minutes during 2 hours after injection	Change in blood pressure

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026