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Physical Activity for a Long and Healthy Life (FINE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Bente Merete Stallknecht, University of Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430143
First Posted: September 7, 2011
Last Update Posted: September 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universitetssenteret på Kjeller
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
  Purpose
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.

Condition Intervention
Overweight Insulin Resistance Diabetes Mellitus, Type 2 Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physical Activity for a Long and Healthy Life - Project FINE

Resource links provided by NLM:


Further study details as provided by Bente Merete Stallknecht, University of Copenhagen:

Primary Outcome Measures:
  • Change from baseline in insulin sensitivity at 12 weeks [ Time Frame: At baseline and 12 weeks ]
    As measured by a hyperinsulinemic, isoglycemic clamp combined with skeletal muscle and adipose tissue biopsies as well as low-dose PET/CT.


Secondary Outcome Measures:
  • Change from baseline in body composition af 2, 6 and 12 weeks [ Time Frame: At baseline, 2, 6 and 12 weeks ]
    As measured by DEXA- and MRI-scanning.

  • Change from baseline in appetite at 12 weeks [ Time Frame: At baseline and 12 weeks ]
    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 ]
    Ethnographic field work

  • Diameter of t-tubuli in skeletal muscle [ Time Frame: At baseline ]
    As measured in skeletal muscle biopsies by electron and confocal microscopy


Enrollment: 64
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 600 kcal/day
Exercise combusting 600 kcal/day, 7 days/week for 12 weeks.
Behavioral: Exercise
Daily exercise for 12 weeks.
Experimental: 300 kcal/day
Exercise combusting 300 kcal/day, 7 days/week for 12 weeks.
Behavioral: Exercise
Daily exercise for 12 weeks.
No Intervention: Sedentary
Continued sedentary living.
Behavioral: Exercise
Daily exercise for 12 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430143


Locations
Denmark
Department of Biomedical Sciences, The University of Copenhagen
Copenhagen, Denmark, DK-2200
Sponsors and Collaborators
University of Copenhagen
Universitetssenteret på Kjeller
Center for Healthy Aging
The Novo Nordic Foundation
Copenhagen University Hospital
Glostrup University Hospital, Copenhagen
  More Information

Additional Information:
Responsible Party: Bente Merete Stallknecht, Associate professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01430143     History of Changes
Other Study ID Numbers: FourINonE
First Submitted: September 1, 2011
First Posted: September 7, 2011
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Bente Merete Stallknecht, University of Copenhagen:
Exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Overweight
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Hyperinsulinism