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Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822003
First Posted: January 14, 2009
Last Update Posted: January 14, 2009
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.
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Basel, Switzerland
  Purpose
The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males

Condition Intervention Phase
Glucose Homeostasis Drug: Oral GLP-1 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile Following an Oral Glucose Tolerance Test in Healthy Male Subjects

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

Secondary Outcome Measures:
  • Glucagon secretion GH release adverse events

Enrollment: 16
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Human GLP-1
Drug: Oral GLP-1
GLP-1 tablet (2mg)
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
Control tablet

Detailed Description:
Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1 is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An oral delivery system would mimick the physiological path of endogenous secretion. Objective: We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male subjects
  • no gastrointestinal or endocrine disorder

Exclusion Criteria:

  • females
  • alcohol or drug abuse
  • active virus hepatitis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00822003


Locations
Switzerland
Clinical Research Center, University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
Principal Investigator: Christoph Beglinger, MD Clinical Research Center, University Hospital Basel
  More Information

Responsible Party: Beglinger Christoph, Prof. Dr.med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00822003     History of Changes
Other Study ID Numbers: EKBB 127/07, Amendment 1
First Submitted: January 13, 2009
First Posted: January 14, 2009
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by University Hospital, Basel, Switzerland:
GLP-1
insulin
glucose

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents