Clinical trial NCT00822705: Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36
Official title: Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36: a Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anti Obesity Agent
Keywords: Appetite, energy consumption, gastrointestinal hormones
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Energy consumption
timeFrame: 1 hour food consumption
Secondary outcomes:
measure: Appetite feelings, plasma kinetics adverse events
timeFrame: adeverse events during study (3 months)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Research Center, University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: CHRISTOPH BEGLINGER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinert RE, Poller B, Castelli MC, Drewe J, Beglinger C. Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects. Am J Clin Nutr. 2010 Oct;92(4):810-7. doi: 10.3945/ajcn.2010.29663. Epub 2010 Aug 18.