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

Phase 4
Conditions
Healthy
Obesity
Interventions
Drug: Saline
Registration Number
NCT03024879
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
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 available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
15
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PlaceboSalinea saline solution of 100 ml will be administered intravenously over a period of 20 min
ErythromycinErythromycin40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
Primary Outcome Measures
NameTimeMethod
Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placeboCaloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake
Secondary Outcome Measures
NameTimeMethod
Frequency of food intake correlated with motilin plasma levelsAssessment will be done over a period of 5 hours
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