NCT01079624

Brief Summary

Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
Last Updated

March 3, 2010

Status Verified

July 1, 2009

Enrollment Period

1.4 years

First QC Date

March 2, 2010

Last Update Submit

March 2, 2010

Conditions

PhysiologyGastroenterologyEndocrinology

Keywords

Incretin hormonesGlucose-insulinotropic peptideGlucagon-like peptide-1Gastric emptyingAppetiteGlucose disposalGut hormones

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying rate

    2005-2006

Secondary Outcomes (1)

  • Plasma glucose, insulin release, appetite

    2005-2006

Study Arms (2)

GIP two doses and GLP-1 one dose

EXPERIMENTAL

Intervention with infusion of GIP or GLP-1 intravenously

Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1

Saline infusion

PLACEBO COMPARATOR

Control

Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1

Interventions

Glucose-insulinotropic peptide, Glucagon-like peptide-1OTHER

GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min

Also known as: GIP, GLP-1, Saline
GIP two doses and GLP-1 one doseSaline infusion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women
  • years old;
  • otherwise healthy and HIV and HCB, HCV negative

You may not qualify if:

  • Age \>50,
  • all types of diseases and drug users.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

Location

MeSH Terms

Interventions

Glucagon-Like Peptide 1Sodium Chloride

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Per M Hellstrom, MD, PhD

    Karolinska Institutet, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 3, 2010

Study Start

August 1, 2006

Primary Completion

January 1, 2008

Study Completion

November 1, 2009

Last Updated

March 3, 2010

Record last verified: 2009-07

Locations

SE(1)