NCT00771940

Brief Summary

The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.

Trial Health

87
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 Oct 2008

Shorter than P25 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, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

3 months

First QC Date

October 8, 2008

Last Update Submit

February 2, 2009

Conditions

Healthy Controls

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of glucose

    During study day

Secondary Outcomes (2)

  • Insulin signaling

    Study day

  • Serum levels of fatty acids

    Study day

Study Arms (1)

Ghrelin

ACTIVE COMPARATOR
Drug: Ghrelin

Interventions

GhrelinDRUG

Solvent, cont. infusion

Ghrelin

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \< 27 kg/m2
  • Written informed consent
  • Non-smoker

You may not qualify if:

  • Any disease including epilepsy
  • Any use of medications (excl. paracetamol)
  • Present or previous malignancy
  • Alcohol dependency
  • Allergy to any trial medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Dk-8000, Denmark

Location

MeSH Terms

Interventions

Ghrelin

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jens Otto L. Jorgensen, MD

    Medical Department M, Aarhus University Horpital, Denmark

    STUDY DIRECTOR

  • Esben T Vestergaard, PhD

    Medical Department M, Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 15, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

DK(1)