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

Anti Obesity Agent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822705
• Other study ID #: EKBB 127/07
• Secondary ID: SNF grant 320000
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 13, 2009
• Last updated: January 13, 2009
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anti Obesity Agent

Intervention

Drug:
• Placebo tablet
Control arm

Locations

Country	Name	City	State
Switzerland	Clinical Research Center, University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy consumption		1 hour food consumption	Yes
Secondary	Appetite feelings, plasma kinetics adverse events		adeverse events during study (3 months)	Yes