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OpenTrials
Completed

NCT Number: NCT02212821

Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects

The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female only.
  • Age > 18 and < 60.
  • Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months).
  • Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder.
  • If female not known to be pregnant.
  • Not known to have any past upper gastrointestinal surgery.

Exclusion criteria

  • Alcohol consumption > 7 drinks / week
  • Major depression and chronic health conditions except controlled hypertension

Treatment and study plan

Erythromycin

Drug

Placebo

Drug

physiological saline

Primary outcomes

  1. Functional brain images

    Time frame: 40 min after intervention

    The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.

Secondary outcomes

  1. hunger scores

    Time frame: every 10 minutes since the scan starts

    The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.

  2. gut hormones

    Time frame: every 10 min since the scan starts

    Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Important dates

Study start
2014
Primary completion
2016
First posted
Aug 8, 2014
Registry last updated
Nov 30, 2016

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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