Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36 (No)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00822705
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Anti Obesity Agent
Drug: Placebo tablet
Phase 1
Phase 2

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

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Energy consumption [ Time Frame: 1 hour food consumption ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Appetite feelings, plasma kinetics adverse events [ Time Frame: adeverse events during study (3 months) ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ORAL GLP-1, TABLET Drug: Placebo tablet
Control arm
Active Comparator: Oral PYY3-36 Drug: Placebo tablet
Control arm
Active Comparator: Oral GLP-1 plus oral PYY3-36 Drug: Placebo tablet
Control arm
Placebo Comparator: 4 Drug: Placebo tablet
Control arm

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00822705

Locations
Switzerland
Clinical Research Center, University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: CHRISTOPH BEGLINGER, MD University Hospital, Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Christoph Beglinger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00822705     History of Changes
Other Study ID Numbers: EKBB 127/07, SNF grant 320000-118330
Study First Received: January 13, 2009
Last Updated: January 13, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Appetite, energy consumption, gastrointestinal hormones

ClinicalTrials.gov processed this record on October 22, 2014