Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile in Healthy Male Subjects (No)

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00822003
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Secondary Outcome Measures:
  • Glucagon secretion GH release adverse events [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 13, 2009
Last Updated: January 13, 2009
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on October 22, 2014