Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

January 15, 2013 updated by: Esben Thyssen Vestergaard

Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ghrelin
Drug: Acyl ghrelin
Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes
Other Names:
  • Ghrelin
  • Human acyl ghrelin
Placebo Comparator: Placebo
Ringer acetate is used for placebo.
Drug: Placebo (Ringer acetate)
Ringer acetate 2 microliter/min for 300 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interstitial concentrations of glycerol
Time Frame: Interstitial concentrations of glycerol at t=120 minutes
Interstitial concentrations of glycerol at t=120 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Interstitial concentrations of lactate
Time Frame: Interstitial concentrations of lactate at t=120 minutes
Interstitial concentrations of lactate at t=120 minutes
Interstitial concentrations of glucose
Time Frame: Interstitial concentrations of glucose at t=120 minutes
Interstitial concentrations of glucose at t=120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esben Thyssen Vestergaard

Investigators

  • Principal Investigator: Esben T. Vestergaard, MD PhD, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-28512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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