NCT01595373

Brief Summary

The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started Jun 2012

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

First Submitted

Initial submission to the registry

May 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

May 7, 2012

Last Update Submit

January 15, 2013

Conditions

Healthy

Keywords

GhrelinMicrodialysisControlsMetabolic effects of ghrelin

Outcome Measures

Primary Outcomes (1)

  • Interstitial concentrations of glycerol

    Interstitial concentrations of glycerol at t=120 minutes

Secondary Outcomes (2)

  • Interstitial concentrations of lactate

    Interstitial concentrations of lactate at t=120 minutes

  • Interstitial concentrations of glucose

    Interstitial concentrations of glucose at t=120 minutes

Study Arms (2)

Ghrelin

ACTIVE COMPARATOR

Ghrelin

Drug: Acyl ghrelin

Placebo

PLACEBO COMPARATOR

Ringer acetate is used for placebo.

Drug: Placebo (Ringer acetate)

Interventions

Acyl ghrelinDRUG

Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes

Also known as: Human acyl ghrelin, Ghrelin
Ghrelin
Placebo (Ringer acetate)DRUG

Ringer acetate 2 microliter/min for 300 minutes

Placebo

Eligibility Criteria

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

You may qualify if:

  • healthy male
  • age 18-65 years (included)
  • Body mass index 20-25 (included)

You may not qualify if:

  • alcohol abuse
  • malignant disease
  • use of any medicine except otc painkillers
  • any disease recognized
  • participation in a trial using radioactive isotopes within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Vestergaard ET, Moller N, Jorgensen JO. Acute peripheral tissue effects of ghrelin on interstitial levels of glucose, glycerol, and lactate: a microdialysis study in healthy human subjects. Am J Physiol Endocrinol Metab. 2013 Jun 15;304(12):E1273-80. doi: 10.1152/ajpendo.00662.2012. Epub 2013 Apr 16.

    PMID: 23592479DERIVED

MeSH Terms

Interventions

acyl-ghrelinGhrelin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Esben T. Vestergaard, MD PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoc PhD

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 10, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2012

Study Completion

January 1, 2013

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

DK(1)