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

Universitaire Ziekenhuizen KU Leuven15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Obesity

Interventions

ErythromycinDRUG

SalineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Frequency of food intake correlated with motilin plasma levels

Time frame: Assessment will be done over a period of 5 hours

Data from ClinicalTrials.gov

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