NEAT and Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01299311
First received: January 17, 2011
Last updated: July 9, 2012
Last verified: July 2012

January 17, 2011
July 9, 2012
December 2010
June 2011   (final data collection date for primary outcome measure)
Change in insulin sensitivity after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise [ Time Frame: day 5 ] [ Designated as safety issue: No ]
Change in insulin sensitivity measured using oral glucose tolerance test
Same as current
Complete list of historical versions of study NCT01299311 on ClinicalTrials.gov Archive Site
Change in fasting triglycerides after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise [ Time Frame: 5 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
NEAT and Insulin Sensitivity
The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People.

The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity and lipid metabolism is unclear. Research recently published shows that activities associated with everyday activities, summarized as NEAT, such as walking and standing, have a much greater role in energy expenditure than exercise. Therefore, the objective of the present study is to evaluate the effect of 4 days of inactivity (mainly sitting), 4 days of everyday activities (sitting, walking and standing), and 4 days of inactivity and exercise (sitting and biking) on glucose metabolism and insulin sensitivity using an oral glucose tolerance test, and on lipid metabolism in sedentary, overweight people. The investigators hypothesize that:

  1. 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight people.
  2. 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4 days of NEAT with equal energy expenditure, in sedentary, overweight people.
  3. Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.

To evaluate the effect of Non-Exercise Activity Thermogenesis (NEAT) on glucose and lipid metabolism in sedentary, overweight people, the subjects included in the study protocol will follow 3 times a certain activity program of 4 days. These activity programs are:

  • Inactivity: 14 hours of sitting, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
  • NEAT: 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.
  • Exercise: 1 hour biking, 13 hours of sitting, 2 hours of everyday activities, 8 hours of sleeping or laying down per day.

The subjects will be biking using a home trainer, measuring energy expenditure, and supervised by one of the members of the research team. They will bike until they have reached a certain amount of kCal. The subjects will wear two accelerometers during all 3 activity programs to evaluate the amount of each activity (sitting, walking, standing, laying/sleeping). The Computer Science and Applications (CSA) Actigraph accelerometer will be placed on the back and the Continuous Activity Monitor (CAM) Maastricht instrument on the leg. Furthermore, the subjects will be requested to note their activities and dietary intake in a diary. After every 4 days of each activity program, an oral glucose tolerance test will be performed in the morning (fasting state) of the next day (day 5). Before and 15, 30, 45, 60, 90, 120 minutes after ingestion of 75 gram of glucose in water, blood will be drawn for measurements of glucose and insulin. Only at baseline (t=0 minutes), blood will be drawn to measure cholesterol, HDL, LDL, triglycerides, apoA and apoB.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Overweight
  • Behavioral: NEAT
    4 days of everyday activities, including 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities and 8 hours of sleeping or laying down per day
  • Behavioral: Exercise
    4 days of activity program, including 1 hour biking (exercise), 13 hours of sitting, 2 hours of everyday activities and 8 hours of sleeping or laying down per day
  • No Intervention: Inactivity
    4 days of inactivity, mainly sitting
  • Active Comparator: NEAT
    4 days of NEAT (everyday activities)
    Intervention: Behavioral: NEAT
  • Active Comparator: Exercise
    4 days of inactivity combined with 1 hour of exercise
    Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18-30 years old
  • BMI between 25.0-30.0 kg/m2
  • Sedentary, defined as maximum of exercise of 1 hour/week and less than 2x/week

Exclusion Criteria:

  • Cardiovascular disease
  • Diabetes mellitus type 1 or 2 or fasting glucose > 6.9 mmol/L
  • Other diseases that make physical activity difficult
  • Alcohol > 2 consumptions/day
  • Illegal drug use and cannabis use
  • Medication use, other than contraception
  • Triglycerides > 3.0 mmol/L
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01299311
MEC 10-2-057
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Nicolaas C Schaper, Prof., MD Maastricht University Medical Center/ University of Maastricht
Maastricht University Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP