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Completed

NCT Number: NCT03160261

Effect of Exenatide on Cortisol Secretion

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tartu University Hospital

Tartu, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide injection

Drug

Single injection of Exenatide 10μg subcutaneously

Primary outcomes

  1. Cortisol peak

    Time frame: every 30 minutes during 2 hours after injection

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

Secondary outcomes

  1. Adrenocorticotropin (ACTH) peak

    Time frame: every 30 minutes during 2 hours after injection

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

  2. Glucose

    Time frame: Glucose measured every 30 minutes during 2 hours after injection

    Glucose values' area under the curve

  3. Growth hormone

    Time frame: every 30 minutes during 2 hours after injection

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

Other outcomes

  1. heart rate

    Time frame: every 30 minutes during 2 hours after injection

    Change in heart rate

  2. Blood pressure

    Time frame: every 30 minutes during 2 hours after injection

    Change in blood pressure

  3. nausea

    Time frame: every 30 minutes during 2 hours after injection

    intensity of nausea in visual analogue scale

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 19, 2017
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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