Physical Activity for a Long and Healthy Life (FINE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Copenhagen.
Recruitment status was  Active, not recruiting
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

September 1, 2011
September 6, 2011
September 2009
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01430143 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Physical Activity for a Long and Healthy Life
Physical Activity for a Long and Healthy Life - Project FINE

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Overweight
  • Insulin Resistance
  • Diabetes Mellitus, Type 2
Behavioral: Exercise
Daily exercise for 12 weeks.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
December 2012
June 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01430143
FourINonE
No
Bente Merete Stallknecht, University of Copenhagen
University of Copenhagen
  • UNIK - Food, Fitness & Pharma
  • Center for Healthy Aging
  • The Novo Nordic Foundation
  • Copenhagen University Hospital
  • Glostrup University Hospital, Copenhagen
Not Provided
University of Copenhagen
September 2011

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