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

Phase 2CompletedNCT00822003

University Hospital, Basel, Switzerland16 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Glucose Homeostasis

Interventions

Oral GLP-1DRUG

GLP-1 tablet (2mg)

PlaceboDRUG

Control tablet

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male subjects * no gastrointestinal or endocrine disorder Exclusion Criteria: * females * alcohol or drug abuse * active virus hepatitis

Locations (1)

Clinical Research Center, University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Outcomes

Secondary Outcomes

Glucagon secretion GH release adverse events

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.