NCT00980083

Brief Summary

Synthetic GLP-1 lowers postprandial (pp) glycemia by stimulating insulin, inhibiting glucagon, and delaying gastric emptying. However, the effects of the endogenous peptide are largely unknown. Using the specific GLP-1 receptor antagonist exendin(9-39)amide (Ex(9-39)) the investigators recently showed that GLP-1 released during intestinal meal perfusion acts as an incretin hormone and as an enterogastrone. As the relative contributions of these effects to controll postprandial glycemia are unclear, the investigators used Ex(9-39) to investigate the mechanisms of action of GLP-1 after an oral meal in humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

9 months

First QC Date

September 17, 2009

Last Update Submit

September 17, 2009

Conditions

Healthy SubjectsGastric Emptying

Keywords

GLP-1exendin(9-39)gastric emptyingincretinhuman

Outcome Measures

Primary Outcomes (1)

  • postprandial blood glucose levels

    -50 min until 210 min after meal intake

Secondary Outcomes (2)

  • gastric emptying rate

    0-210min

  • plasma levels of glucagon, insulin

    -50min until 210 min

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Saline

Exendin(9-39)

ACTIVE COMPARATOR
Drug: Exendin(9-39)amide

Interventions

SalineDRUG
Placebo
Exendin(9-39)amideDRUG
Exendin(9-39)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subject
  • \>=18 years of age
  • No medication

You may not qualify if:

  • Acute disease
  • Metabolic disease
  • On medication
  • Pregnancy, breast feeding
  • Gastrointestinal surgery
  • Dyspeptische Symptome (Völlegefühl, Blähungen, abdominelle Schmerzereignisse, Übelkeit, Erbrechen, Sodbrennen)
  • Teilnahme an einer klinischen Studie in den vergangenen 6 Monaten

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine II, University of Munich

Munich, 81377, Germany

Location

MeSH Terms

Interventions

Sodium Chlorideexendin (9-39)

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Joerg Schirra, Prof

    University of Munich, Department of Internal Medicine II, Munich, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

October 1, 2004

Primary Completion

July 1, 2005

Study Completion

December 1, 2007

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

DE(1)