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Trial record 32 of 182 for:    ERYTHROMYCIN

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

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ClinicalTrials.gov Identifier: NCT02212821
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : November 30, 2016
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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

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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
intravenous infusion
Drug: Placebo
physiological saline

Experimental: Erythromycin
intravenous infusion
Drug: Erythromycin



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212821


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Principal Investigator: Jan Tack University of Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02212821     History of Changes
Other Study ID Numbers: Erythromycin_v6
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: August 2014
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action