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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02855541
Other study ID # UColoradoBoulder
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date June 2017

Study information

Verified date November 2018
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Previous research suggests that prolonged sitting increases risk for cardiometabolic diseases and the risk factors associated with cardiometabolic diseases. However, no study to date has examined if a chronic intervention that breaks up prolonged sitting in a real-world environment results in a reduction in the metabolic risk factors associated with cardiometabolic diseases. Thus, the objective of this study is to examine the potential health benefits of breaking up sitting bouts throughout the workday using a small cycling device (DeskCycle) in office workers involved with jobs that require prolonged bouts of sitting. The investigators hypothesize that breaking up sitting will be associated with improvements in cardiometabolic disease risk factors. More specifically, the investigators hypothesize that breaking up sitting will decrease blood glucose during an oral glucose tolerance test (OGTT), increase cardiorespiratory fitness (VO2max), decrease blood pressure, decrease body fat, increase HDL cholesterol, and decrease LDL cholesterol, total cholesterol, and triglycerides.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Both males and females

- Subjects will need to be 18-55 years old

- Subjects will need to be sitting at least 6 hours/day on 5 days/week

- Subjects will need to be exercising less than 5 hour/week

Exclusion Criteria:

- Females that are pregnant or breast-feeding.

- Subjects must be free from any acute or chronic physical condition that would influence the outcome measures of the protocol. Examples include, but are not limited to advanced chronic disease states (chronic kidney, liver, heart, or lung disease), morbid obesity, emphysema, and an inability to use the legs for normal locomotion. Normality will be established on the basis of clinical history, physical exam, and vital signs. Any subject with a history of an uncontrolled metabolic disorder/disease or symptoms of active illness will be excluded from study. Any subject with a history of an uncontrolled metabolic disorder/disease such as diabetes (Type I or Type II) or symptoms of active illness will be excluded from study.

- Subjects will be excluded if they have a fasted blood glucose level >126 mg/dl or a systolic blood pressure >140 mmHg.

- Medical/psychiatric/sleep disorders history: any clinically significant unstable medical or psychological condition within the last year (treated or untreated).

- Drug use:

- Use of any medications, including over-the-counter and herbal products, that may affect metabolic function within 1 month prior to the study or need to use any of these medications at any time during the study (self-report by interview). Examples of potential medications that will exclude a subject include: beta-adrenergic blockers, sulfonylureas, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, and dipeptidyl peptidase IV inhibitors. Note, subjects may be tested at a later date.

- Use of any investigational drug within 1 month before the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
DeskCycle
A small cycling ergometer that can fit under a desk at the workplace.

Locations

Country Name City State
United States University of Colorado Boulder Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Glucose 2-h Post Oral Glucose Tolerance Test Blood Glucose Measured after 4 weeks
Primary Maximum Oxygen Consumption Maximum oxygen consumption (VO2max) will be used to determine physical fitness Measured after 4 weeks
Secondary Systolic Blood Pressure Measured after 4 weeks
Secondary HDL Cholesterol Measured after 4 weeks
Secondary LDL Cholesterol Measured after 4 weeks
Secondary Triglycerides Measured after 4 weeks
Secondary Lean Mass Measured after 4 weeks
Secondary Fat Mass Measured after 4 weeks
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