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Consequences of Human Inactivity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inge Holm, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01828229
First received: April 5, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes.

The present protocol is divided in several in several sub-studies:

  1. To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
  2. To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
  3. To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.

Condition Intervention
Inactivity
Obesity
Type 2 Diabetes
Behavioral: female inactivity and hypercaloric diet
Behavioral: inactivity
Behavioral: inactivity and hypercaloric diet
Behavioral: normal activity and hypercaloric diet
Behavioral: inactivity and iso-caloric diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Consequences of Human Inactivity

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test


Secondary Outcome Measures:
  • visceral adiposity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Amount of visceral fat is determined by MRI scans


Other Outcome Measures:
  • Cognitive function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Assessed by the Conner's Continuous Performance Test II 2000

  • aerobic fitness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer


Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: female inactivity and hypercaloric diet
inactivity and hypercaloric diet in women for two weeks
Behavioral: female inactivity and hypercaloric diet
female inactivity and hypercaloric diet for 2 weeks
Experimental: inactivity
Inactivity for two weeks
Behavioral: inactivity
inactivity for 2 weeks
Experimental: inactivity and hypercaloric diet
inactivity and hypercaloric diet for two weeks
Behavioral: inactivity and hypercaloric diet
inactivity and hypercaloric diet for 2 weeks
Experimental: normal activity and hypercaloric diet
Normal activity and hypercaloric diet for two weeks
Behavioral: normal activity and hypercaloric diet
normal activity and hypercaloric diet for 2 weeks
Active Comparator: inactivity and iso-caloric diet
inactivity and iso-caloric diet for two weeks
Behavioral: inactivity and iso-caloric diet
inactivity and iso-caloric diet for 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal physical active
  • Healthy
  • 18-40 y of age
  • Non-smokers

Exclusion Criteria:

  • Pregnancy
  • Diabetes in family
  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: NCT01828229

Locations
Denmark
Center og inflammation and metabolism, Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Inge Holm, Administrator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01828229     History of Changes
Other Study ID Numbers: H-4-2009-082
Study First Received: April 5, 2013
Last Updated: April 9, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Inactivity
Obesity
Type 2 diabetes
glucose metabolism
Lipid metabolism
Cognitive function

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014