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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Notify MeKey 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
Placebo
Drugphysiological saline
Primary outcomes
-
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
-
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.
-
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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