NCT00512525

Brief Summary

Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of this study is to investigate the effect of short term ghrelin administration to humans on metabolism.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

9 months

First QC Date

August 6, 2007

Last Update Submit

September 8, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    End of clamp period

Secondary Outcomes (1)

  • Effects on lipolysis

    End of basal and end og clamp period

Study Arms (1)

2

PLACEBO COMPARATOR
Drug: Ghrelin and saline (as placebo)

Interventions

Ghrelin and saline (as placebo)DRUG

Intravenous infusion

2

Eligibility Criteria

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

You may qualify if:

  • healthy men, age \>= 18 yr age \< 50 yr, body mass index \< 27.5 kg/m2above or equal to 18 yr

You may not qualify if:

  • any disease, use of prescribed medication, age \< 18 yr or \>= 50 yr

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

GhrelinSodium Chloride

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ole Schmitz, MD

    Department of Pharmacology, University of Aarhus, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

January 1, 2003

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

September 9, 2009

Record last verified: 2009-09