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OpenTrials
Completed

NCT Number: NCT00822003

Effects of Oral GLP-1 on Glucose Homeostasis and Appetite Profile 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

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Research Center, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male subjects
  • no gastrointestinal or endocrine disorder

Exclusion criteria

  • females
  • alcohol or drug abuse
  • active virus hepatitis

Treatment and study plan

Oral GLP-1

Drug

GLP-1 tablet (2mg)

Placebo

Drug

Control tablet

Secondary outcomes

  1. Glucagon secretion GH release adverse events

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 14, 2009
Registry last updated
Jan 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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