- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160261
Effect of Exenatide on Cortisol Secretion
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Tartu, Estonia
- Tartu University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exenatide
Single injection of 10 μg Exenatide subcutaneously.
|
Single injection of Exenatide 10μg subcutaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol peak
Time Frame: every 30 minutes during 2 hours after injection
|
Maximum concentration achieved after exenatide dose (any timepoint after injection)
|
every 30 minutes during 2 hours after injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adrenocorticotropin (ACTH) peak
Time Frame: every 30 minutes during 2 hours after injection
|
Maximum concentration achieved after exenatide dose (any timepoint after injection)
|
every 30 minutes during 2 hours after injection
|
Glucose
Time Frame: Glucose measured every 30 minutes during 2 hours after injection
|
Glucose values' area under the curve
|
Glucose measured every 30 minutes during 2 hours after injection
|
Growth hormone
Time Frame: every 30 minutes during 2 hours after injection
|
Maximum concentration achieved after exenatide dose (any timepoint after injection)
|
every 30 minutes during 2 hours after injection
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate
Time Frame: every 30 minutes during 2 hours after injection
|
Change in heart rate
|
every 30 minutes during 2 hours after injection
|
Blood pressure
Time Frame: every 30 minutes during 2 hours after injection
|
Change in blood pressure
|
every 30 minutes during 2 hours after injection
|
nausea
Time Frame: every 30 minutes during 2 hours after injection
|
intensity of nausea in visual analogue scale
|
every 30 minutes during 2 hours after injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vallo Volke, MD,PhD, Tartu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ex17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Exenatide Injection
-
PegBio Co., Ltd.Completed
-
University of Maryland, BaltimoreTerminated
-
The First Affiliated Hospital of Xiamen UniversityCompletedDiabetes Mellitus, Type 2China
-
Neuroscience Trials AustraliaNational Health and Medical Research Council, Australia; Monash UniversityActive, not recruitingAcute Ischemic StrokeAustralia, Finland, New Zealand
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusUnited States
-
TheracosCompletedType2 Diabetes MellitusUnited States
-
Xiangya Hospital of Central South UniversityRecruiting
-
Intarcia TherapeuticsCompletedType 2 DiabetesUnited States
-
AstraZenecaCompletedType 2 Diabetes MellitusCanada, United States
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusKorea, Republic of, China, Japan, Taiwan, India