Effect of Exenatide on Cortisol Secretion

University of Tartu

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Exenatide Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03160261

Ex17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Exenatide

Experimental group

Description:

Single injection of 10 μg Exenatide subcutaneously.

Treatment:

Drug: Exenatide Injection