Peripheral Metabolic Effects of Ghrelin

February 2, 2009 updated by: University of Aarhus

Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • 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, Dk-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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. BMI < 27 kg/m2
  2. Written informed consent
  3. Non-smoker

Exclusion Criteria:

  1. Any disease including epilepsy
  2. Any use of medications (excl. paracetamol)
  3. Present or previous malignancy
  4. Alcohol dependency
  5. Allergy to any trial medication

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ghrelin
Drug: Ghrelin
Solvent, cont. infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of glucose
Time Frame: During study day
During study day

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin signaling
Time Frame: Study day
Study day
Serum levels of fatty acids
Time Frame: Study day
Study day

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Study Director: Jens Otto L. Jorgensen, MD, Medical Department M, Aarhus University Horpital, Denmark
  • Principal Investigator: Esben T Vestergaard, PhD, Medical Department M, Aarhus University Hospital, Denmark

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

October 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 13, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2009

Last Update Submitted That Met QC Criteria

February 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • M-2007008

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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