Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36

Study Overview
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Brief Summary
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Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects

Detailed Description
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PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from L-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type II. The regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. In many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions. From studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. In contrast, we have been unable to show in healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically. To further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their interaction in the control of food intake and satiety in healthy male subjects.

Official Title
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Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36: a Phase 1 Study

Conditions
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Anti Obesity Agent

Intervention / Treatment
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* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects no evidence of disease no history of gastrointestinal or endocrine disorders Exclusion Criteria: alcohol and drug abuse history of gastrointestinal or endocrine disorders female subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ORAL GLP-1, TABLET<br> | Drug: Placebo tablet<br>* Control arm<br>|
| Active Comparator: Oral PYY3-36<br> | Drug: Placebo tablet<br>* Control arm<br>|
| Active Comparator: Oral GLP-1 plus oral PYY3-36<br> | Drug: Placebo tablet<br>* Control arm<br>|
| Placebo Comparator: 4<br> | Drug: Placebo tablet<br>* Control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy consumption |  | 1 hour food consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite feelings, plasma kinetics adverse events |  | adeverse events during study (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appetite, energy consumption, gastrointestinal hormones