Effect of Exenatide on Cortisol Secretion

May 2, 2018 updated by: Vallo Volke, University of Tartu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia
        • Tartu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Exenatide Injection
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Investigators

  • Principal Investigator: Vallo Volke, MD,PhD, Tartu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2017

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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