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
  Purpose

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.

Condition Intervention
Overweight
Behavioral: NEAT
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Inactivity
4 days of inactivity, mainly sitting
Active Comparator: NEAT
4 days of NEAT (everyday activities)
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
Active Comparator: Exercise
4 days of inactivity combined with 1 hour of exercise
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01299311

Locations
Netherlands
Maastricht University Medical Center/ University of Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Nicolaas C Schaper, Prof., MD Maastricht University Medical Center/ University of Maastricht
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01299311     History of Changes
Other Study ID Numbers: MEC 10-2-057
Study First Received: January 17, 2011
Last Updated: July 9, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
insulin sensitivity

Additional relevant MeSH terms:
Overweight
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014