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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Invitation-only; Phase 4

Conditions: Healthy; Obesity

Treatments: Drug: Saline; Drug: Erythromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03024879

MotilinAndFoodIntake

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Erythromycin

Active Comparator group

Description:

40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml

Treatment:

Drug: Erythromycin

Placebo

Placebo Comparator group

Description:

a saline solution of 100 ml will be administered intravenously over a period of 20 min

Treatment:

Drug: Saline