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NEAT and Insulin Sensitivity

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
NEAT
Exercise
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring insulin sensitivity

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center/ University of Maastricht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Inactivity

NEAT

Exercise

Arm Description

4 days of inactivity, mainly sitting

4 days of NEAT (everyday activities)

4 days of inactivity combined with 1 hour of exercise

Outcomes

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
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

Full Information

First Posted
January 17, 2011
Last Updated
July 9, 2012
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01299311
Brief Title
NEAT and Insulin Sensitivity
Official Title
The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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. 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. Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inactivity
Arm Type
No Intervention
Arm Description
4 days of inactivity, mainly sitting
Arm Title
NEAT
Arm Type
Active Comparator
Arm Description
4 days of NEAT (everyday activities)
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
4 days of inactivity combined with 1 hour of exercise
Intervention Type
Behavioral
Intervention Name(s)
NEAT
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in insulin sensitivity after 4 days of NEAT compared to 4 days of inactivity and compared to 4 days of exercise
Description
Change in insulin sensitivity measured using oral glucose tolerance test
Time Frame
day 5
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaas C Schaper, Prof., MD
Organizational Affiliation
Maastricht University Medical Center/ University of Maastricht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center/ University of Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

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