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Trial record 12 of 406 for:    PYY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822705
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Information provided by:
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
Anti Obesity Agent Drug: Placebo tablet Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Energy consumption [ Time Frame: 1 hour food consumption ]

Secondary Outcome Measures :
  1. Appetite feelings, plasma kinetics adverse events [ Time Frame: adeverse events during study (3 months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00822705

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Christoph Beglinger, University Hospital, Basel, Switzerland Identifier: NCT00822705     History of Changes
Other Study ID Numbers: EKBB 127/07
SNF grant 320000-118330
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009
Keywords provided by University Hospital, Basel, Switzerland:
Appetite, energy consumption, gastrointestinal hormones
Additional relevant MeSH terms:
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Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs