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Trial record 25 of 185 for:    ERYTHROMYCIN

The Effect of Motilin on the Frequency and Amount of Food Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03024879
Recruitment Status : Unknown
Verified January 2017 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Enrolling by invitation
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE January 19, 2017
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2017)
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo [ Time Frame: Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2017)
Frequency of food intake correlated with motilin plasma levels [ Time Frame: Assessment will be done over a period of 5 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Motilin on the Frequency and Amount of Food Intake
Official Title  ICMJE Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
Brief Summary In this study, the investigators aimed at evaluating the role of motilin in the regulation of food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers and is significantly increased in obese patients. Its role in food intake regulation might contribute to the pathogenesis of obesity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Obesity
Intervention  ICMJE
  • Drug: Erythromycin
  • Drug: Saline
Study Arms  ICMJE
  • Active Comparator: Erythromycin
    40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
    Intervention: Drug: Erythromycin
  • Placebo Comparator: Placebo
    a saline solution of 100 ml will be administered intravenously over a period of 20 min
    Intervention: Drug: Saline
Publications * Deloose E, Biesiekierski JR, Vanheel H, Depoortere I, Tack J. Effect of motilin receptor activation on food intake and food timing. Am J Clin Nutr. 2018 Apr 1;107(4):537-543. doi: 10.1093/ajcn/nqx044.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 16, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI < 30 kg/m² for lean volunteers
  • BMI > 30 kg/m² for obese volunteers
  • Subject is capable and willing to give informed consent
  • Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

Exclusion Criteria:

  • Female volunteer is pregnant or breastfeeding
  • GI diseases, major abdominal surgery
  • Major psychiatric illnesses
  • Volunteers that use drugs affecting the GI tract or the central nervous system
  • Volunteers suffering from endocrine diseases such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
  • Volunteers that have undergone surgical procedure for weight loss
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03024879
Other Study ID Numbers  ICMJE MotilinAndFoodIntake
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Tack, Prof Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP