Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Esben Thyssen Vestergaard, University of Aarhus

ClinicalTrials.gov Identifier:

NCT01595373

First received: May 7, 2012

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 7, 2012

Last Updated Date

January 15, 2013

Start Date ^ICMJE

June 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Interstitial concentrations of glycerol [ Time Frame: Interstitial concentrations of glycerol at t=120 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01595373 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Interstitial concentrations of lactate [ Time Frame: Interstitial concentrations of lactate at t=120 minutes ] [ Designated as safety issue: No ]
Interstitial concentrations of glucose [ Time Frame: Interstitial concentrations of glucose at t=120 minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

Official Title ^ICMJE

Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Acyl ghrelin
Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes
Other Names:
- Human acyl ghrelin
- Ghrelin
Drug: Placebo (Ringer acetate)
Ringer acetate 2 microliter/min for 300 minutes

Study Arm (s)

Active Comparator: Ghrelin
Ghrelin

Intervention: Drug: Acyl ghrelin
Placebo Comparator: Placebo
Ringer acetate is used for placebo.

Intervention: Drug: Placebo (Ringer acetate)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01595373

Other Study ID Numbers ^ICMJE

2012-28512

Has Data Monitoring Committee

Responsible Party

Esben Thyssen Vestergaard, University of Aarhus

Study Sponsor ^ICMJE

Esben Thyssen Vestergaard

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Esben T. Vestergaard, MD PhD

University of Aarhus

Information Provided By

University of Aarhus

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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