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Clinical Trials/NCT01962259
NCT01962259
Completed
N/A

Active Commuting To Improve Well-being and Health in Everyday Life

University of Copenhagen1 site in 1 country188 target enrollmentNovember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
University of Copenhagen
Enrollment
188
Locations
1
Primary Endpoint
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.

Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
July 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bente Merete Stallknecht

Professor

University of Copenhagen

Eligibility Criteria

Inclusion Criteria

  • No engagement in habitual structured physical activity
  • Body mass index 25-35 kg/m2
  • Body fat percentage \>32% for women and \>25% for men
  • Maximum oxygen uptake (VO2max) \<40 ml O2/kg/min for women and \<45 ml O2/kg/min for men
  • Ethnicity: Caucasian

Exclusion Criteria

  • Chronic use of medicine
  • Fasting plasma glucose \> 6,1 mmol/L
  • Blood pressure \> 140/90 mm Hg
  • Abnormal resting and working ECG
  • Parents or siblings with diagnosed type 2 diabetes
  • For women: Follicle stimulating hormone (FSH) concentration \> 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year

Outcomes

Primary Outcomes

Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)

Time Frame: Change from baseline in peripheral insulin sensitivity at 6 months

Measured using the hyper-insulinemic euglycaemic clamp

Haemostatic balance

Time Frame: Change from baseline in endogenous thrombin potential at 6 months

Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)

Secondary Outcomes

  • Glycaemic control(Baseline, 3 and 6 months)
  • Abdominal fat mass(Baseline, 3 and 6 months)
  • Health related quality of life and other psycho-social outcomes(Baseline, 3 and 6 months)
  • Anthropometry(Baseline, 3 and 6 months)
  • Sleep habits(Baseline, 3 and 6 months)
  • Subcutaneous adipose tissue biopsy(Baseline, 3 and 6 months)
  • Haemostatic balance II(Baseline, 3 and 6 months)
  • Metabolic syndrome(Baseline, 3 and 6 months)
  • Central insulin sensitivity(Baseline, 3 and 6 months)
  • Maximal oxygen uptake (ml/O2/kg/min)(Baseline, 3 and 6 months)
  • Skeletal muscle biopsy(Baseline, 3 and 6 months)

Study Sites (1)

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