Effect of Exenatide on Cortisol Secretion
- Registration Number
- NCT03160261
- Lead Sponsor
- University of Tartu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Age 18-50 years
- Body weight >65 kg
- Presence of chronic illness
- daily use of any medicines
- pregnancy, lactation
- use of oral contraceptives during previous 2 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exenatide Exenatide Injection Single injection of 10 μg Exenatide subcutaneously.
- Primary Outcome Measures
Name Time Method Cortisol peak every 30 minutes during 2 hours after injection Maximum concentration achieved after exenatide dose (any timepoint after injection)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Tartu University Hospital
🇪🇪Tartu, Estonia