NEAT and Insulin Sensitivity
| Tracking Information | |||||
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| First Received Date ICMJE | January 17, 2011 | ||||
| Last Updated Date | July 9, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01299311 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NEAT and Insulin Sensitivity | ||||
| Official Title ICMJE | The Effect of Activity on Insulin Sensitivity and Lipid Metabolism in Sedentary, Overweight People. | ||||
| 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:
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Overweight | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 18 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 30 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01299311 | ||||
| Other Study ID Numbers ICMJE | MEC 10-2-057 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Maastricht University Medical Center | ||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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