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

January 13, 2009 updated by: University Hospital, Basel, Switzerland

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Clinical Research Center, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male subjects
  • no gastrointestinal or endocrine disorder

Exclusion Criteria:

  • females
  • alcohol or drug abuse
  • active virus hepatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
Control tablet
Active Comparator: 1
Human GLP-1
Drug: Oral GLP-1
GLP-1 tablet (2mg)

What is the study measuring?

Secondary Outcome Measures

Outcome Measure
Glucagon secretion GH release adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Christoph Beglinger, MD, Clinical Research Center, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKBB 127/07, Amendment 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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