NCT03160261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

April 24, 2017

Last Update Submit

May 2, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Cortisol peak

    Maximum concentration achieved after exenatide dose (any timepoint after injection)

    every 30 minutes during 2 hours after injection

Secondary Outcomes (3)

  • Adrenocorticotropin (ACTH) peak

    every 30 minutes during 2 hours after injection

  • Glucose

    Glucose measured every 30 minutes during 2 hours after injection

  • Growth hormone

    every 30 minutes during 2 hours after injection

Other Outcomes (3)

  • heart rate

    every 30 minutes during 2 hours after injection

  • Blood pressure

    every 30 minutes during 2 hours after injection

  • nausea

    every 30 minutes during 2 hours after injection

Study Arms (1)

Exenatide

EXPERIMENTAL

Single injection of 10 μg Exenatide subcutaneously.

Drug: Exenatide Injection

Interventions

Exenatide InjectionDRUG

Single injection of Exenatide 10μg subcutaneously

Exenatide

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50 years
  • Body weight \>65 kg

You may not qualify if:

  • Presence of chronic illness
  • daily use of any medicines
  • pregnancy, lactation
  • use of oral contraceptives during previous 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, Estonia

Location

Related Publications (1)

  • Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.

    PMID: 36800161DERIVED

MeSH Terms

Interventions

Exenatide

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Vallo Volke, MD,PhD

    University of Tartu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single-group, open-label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 19, 2017

Study Start

September 7, 2017

Primary Completion

December 28, 2017

Study Completion

December 28, 2017

Last Updated

May 3, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)