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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT02212821
• Collaborator: KU Leuven (Other)
• Enrollment: 14
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Erythromycin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo intravenous infusion	Drug: Placebo; physiological saline
Experimental: Erythromycin intravenous infusion	Drug: Erythromycin

Outcome Measures

Primary Outcome Measures

1. Functional brain images [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 Outcome Measures

1. hunger scores [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven
• KU Leuven

Investigators

• Principal Investigator: Jan Tack, University of Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT02212821
• Other Study ID Numbers: Erythromycin_v6
• First Posted: Aug 8, 2014
• Last Update Posted: Nov 30, 2016
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Study Results

No Results Posted as of Nov 30, 2016