Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat (FEIGH)

This study has been completed.

Sponsor:

Information provided by:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT00817440

First received: January 5, 2009

Last updated: January 10, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 5, 2009
Last Updated Date	January 10, 2011
Start Date ^ICMJE	December 2008
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 5, 2009)	Growth hormone and insulin signal pathways [ Time Frame: 30 min ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00817440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 5, 2009)	aminoacid and glucose turnover [ Time Frame: 4 hours ] [ 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	Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
Official Title ^ICMJE	Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
Brief Summary	Hypothesis: under fasting there will primarily be an activation of growth hormone(GH) signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under physical activity. Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max. In addition to this we will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Other: Exercise 1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1. Other: Fasting 3 days of fasting and then the same as arm 1
Study Arm (s)	No Intervention: Control control: muscle and fat biopsies and basal aminoacid and glucose turnover Experimental: Exercise 1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1. Intervention: Other: Exercise Experimental: Fasting 3 days of fasting and then the same as arm 1 Intervention: Other: Fasting
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	8
Completion Date	Not Provided
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: healthy men Body mass index (BMI) 20-26 age 18-45 years Exclusion Criteria: any kind of disease any use of medicine
Gender	Male
Ages	18 Years to 45 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	NCT00817440
Other Study ID Numbers ^ICMJE	16.12.2008
Has Data Monitoring Committee	Not Provided
Responsible Party	Mikkel Vendelbo MD, endokrinologiskforskningslaboratorium M, Aarhus sygehus
Study Sponsor ^ICMJE	University of Aarhus
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Aarhus
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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