NEAT and Insulin Sensitivity

Overweight Clinical Trial

Official title:

The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299311
• Other study ID #: MEC 10-2-057
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: July 9, 2012
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Overweight

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center/ University of Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise	Change in insulin sensitivity measured using oral glucose tolerance test	day 5	No
Secondary	Change in fasting triglycerides after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise		5 day	No