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

Glucose Homeostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822003
• Other study ID #: EKBB 127/07, Amendment 1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 13, 2009
• Last updated: January 13, 2009
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy male subjects

• no gastrointestinal or endocrine disorder

Exclusion Criteria:

• females

• alcohol or drug abuse

• active virus hepatitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Homeostasis

Intervention

Drug:
• Oral GLP-1
GLP-1 tablet (2mg)
• Placebo
Control tablet

Locations

Country	Name	City	State
Switzerland	Clinical Research Center, University Hospital Basel	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Glucagon secretion GH release adverse events			Yes