Physical Activity for a Long and Healthy Life (FINE)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

UNIK - Food, Fitness & Pharma

Center for Healthy Aging

The Novo Nordic Foundation

Copenhagen University Hospital

Glostrup University Hospital, Copenhagen

Information provided by (Responsible Party):

Bente Merete Stallknecht, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01430143

First received: September 1, 2011

Last updated: September 6, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 1, 2011
Last Updated Date	September 6, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 6, 2011)	Change from baseline in insulin sensitivity at 12 weeks [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ] As measured by a hyperinsulinemic, isoglycemic clamp combined with skeletal muscle and adipose tissue biopsies as well as low-dose PET/CT.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01430143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 6, 2011)	Change from baseline in body composition af 2, 6 and 12 weeks [ Time Frame: At baseline, 2, 6 and 12 weeks ] [ Designated as safety issue: No ] As measured by DEXA- and MRI-scanning. Change from baseline in appetite at 12 weeks [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ] As measured by food records, controlled diets, meal tests and appetite hormones Motivational factors for exercise [ Time Frame: During and for up to 1½ year after the intervention ] [ Designated as safety issue: No ] Ethnographic field work Diameter of t-tubuli in skeletal muscle [ Time Frame: At baseline ] [ Designated as safety issue: No ] As measured in skeletal muscle biopsies by electron and confocal microscopy
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	Physical Activity for a Long and Healthy Life
Official Title ^ICMJE	Physical Activity for a Long and Healthy Life - Project FINE
Brief Summary	The aim of the study is to 1) delineate the molecular mechanisms behind the large variation in insulin sensitivity among apparently healthy subjects and to 2) establish the dose-response relationship between physical training and a) metabolic health, b) appetite and c) cultural health.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Overweight Insulin Resistance Diabetes Mellitus, Type 2
Intervention ^ICMJE	Behavioral: Exercise Daily exercise for 12 weeks.
Study Arm (s)	Experimental: 600 kcal/day Exercise combusting 600 kcal/day, 7 days/week for 12 weeks. Intervention: Behavioral: Exercise Experimental: 300 kcal/day Exercise combusting 300 kcal/day, 7 days/week for 12 weeks. Intervention: Behavioral: Exercise No Intervention: Sedentary Continued sedentary living. Intervention: Behavioral: Exercise
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	Active, not recruiting
Enrollment ^ICMJE	64
Estimated Completion Date	December 2012
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy according to interview Caucasian Sedentary, Vo2max < 45 ml/kg/min BMI 25-30 kg/m2 Fat percentage 25% < Weight stable (+/- 2 kg within past 6 months) Exclusion Criteria: First degree relatives with type 2 diabetes Hemoglobin concentration < 8 mmol/l Fasting plasma glucose 6.1 mmol/l < Blood pressure 140/90 mmHg < Regular intake of medicine
Gender	Male
Ages	20 Years to 40 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	NCT01430143
Other Study ID Numbers ^ICMJE	FourINonE
Has Data Monitoring Committee	No
Responsible Party	Bente Merete Stallknecht, University of Copenhagen
Study Sponsor ^ICMJE	University of Copenhagen
Collaborators ^ICMJE	UNIK - Food, Fitness & Pharma Center for Healthy Aging The Novo Nordic Foundation Copenhagen University Hospital Glostrup University Hospital, Copenhagen
Investigators ^ICMJE	Not Provided
Information Provided By	University of Copenhagen
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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