Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Copenhagen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430143

Locations
Denmark
Department of Biomedical Sciences, The University of Copenhagen
Copenhagen, Denmark, DK-2200
Sponsors and Collaborators
University of Copenhagen
UNIK - Food, Fitness & Pharma
Center for Healthy Aging
The Novo Nordic Foundation
Copenhagen University Hospital
Glostrup University Hospital, Copenhagen
  More Information

Additional Information:
No publications provided

Responsible Party: Bente Merete Stallknecht, Associate professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01430143     History of Changes
Other Study ID Numbers: FourINonE
Study First Received: September 1, 2011
Last Updated: September 6, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Exercise

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

ClinicalTrials.gov processed this record on November 25, 2014