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

University Hospital Basel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Anti Obesity Agent

Treatments: Drug: Placebo tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT00822705

EKBB 127/07

SNF grant 320000-118330

Details and patient eligibility

About

Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects

Full description

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups, including a placebo group

ORAL GLP-1, TABLET

Active Comparator group

Treatment:

Drug: Placebo tablet

Oral PYY3-36

Active Comparator group

Treatment:

Drug: Placebo tablet

Oral GLP-1 plus oral PYY3-36

Active Comparator group

Treatment:

Drug: Placebo tablet

4

Placebo Comparator group

Treatment:

Drug: Placebo tablet