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OpenTrials
Completed

NCT Number: NCT01430143

Physical Activity for a Long and Healthy Life

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.

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Key information

Conditions

Overweight Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Sciences, The University of Copenhagen

Copenhagen, DK-2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Daily exercise for 12 weeks.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. Motivational factors for exercise

    Time frame: During and for up to 1½ year after the intervention

    Ethnographic field work

  4. Diameter of t-tubuli in skeletal muscle

    Time frame: At baseline

    As measured in skeletal muscle biopsies by electron and confocal microscopy

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Center for Healthy Aging
  • Copenhagen University Hospital, Denmark
  • Glostrup University Hospital, Copenhagen
  • The Novo Nordic Foundation
  • Universitetssenteret på Kjeller

Registry information

Official study title

Physical Activity for a Long and Healthy Life - Project FINE

Acronym: FINE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 7, 2011
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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