NCT00116025

Brief Summary

The main purpose of this study is to determine the half life of the hormone "ghrelin" in the human body. Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

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

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

February 28, 2007

Status Verified

February 1, 2007

First QC Date

June 26, 2005

Last Update Submit

February 27, 2007

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Human ghrelin half life in healthy subjects

Secondary Outcomes (1)

  • Cardiovascular indices (stroke-velocity index, TEI-index)

Interventions

Human acylated ghrelinDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male
  • BMI \< 25 kg/m2
  • Non-smoker
  • Age \< 40 yrs

You may not qualify if:

  • Any known disease
  • Any medication (except OTCs)
  • Former malignant disease
  • Alcoholism
  • Blood donation (with in 6 months)
  • Allergy to test medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Vestergaard ET, Gormsen LC, Jessen N, Lund S, Hansen TK, Moller N, Jorgensen JO. Ghrelin infusion in humans induces acute insulin resistance and lipolysis independent of growth hormone signaling. Diabetes. 2008 Dec;57(12):3205-10. doi: 10.2337/db08-0025. Epub 2008 Sep 5.

    PMID: 18776138DERIVED

Study Officials

  • Jens Otto L Jorgensen, DrMedSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

March 1, 2005

Study Completion

January 1, 2006

Last Updated

February 28, 2007

Record last verified: 2007-02

Locations

DK(1)