Clinical Trials Logo

Clinical Trial Summary

Prolonged sitting is a common behavior in contemporary humans. In epidemiological studies, increased sitting time has been associated with increased risk for cardiovascular disease and all-cause mortality. Recent research has also shown that interrupting sitting time with standing prevents the poorer glycemic control. However, studies are lacking which evaluate the impact of low intensity physical activity during prolonged sitting on vascular function. Whether low intensity physical activity can increase blood flow substantially and prevent impairment in vascular function and glycemic control is unknown.

The purpose of the present study is to evaluate whether increased blood flow during sitting via low intensity physical activity (fidgetting) prevents the impairment in vascular function and poorer glycemic control associated with prolonged sitting.


Clinical Trial Description

Experimental Design: Twenty obese subjects with metabolic syndrome will complete 2 study days with measures vascular function and glycemic control. On one study day, the subjects will sit quietly for 3 hours and on the second study day subjects will sit quietly for 3 hours and simultaneously move their legs using fidgetting.

VISIT 1: All visits will be in Gwynn Hall. On this visit subjects will be consented in the following manner: a review of the inclusion/exclusion criteria and discussion of the informed consent form including an oral explanation of the study purpose, protocol, and potential risks and benefits. Potential subjects will be given time to read the consent form and ask questions of the study personnel. After signing the informed consent, the popliteal artery will be imaged by Doppler ultrasound to ensure that the subject is a candidate for the study. Body composition will be measured and waist measurements will be made. Questionnaires will be filled out. Subjects will be asked to fill out a one day food record on the day prior to each study visit.

VISIT 2 and 3: Upon arrival to the laboratory, subjects will be asked to use the bathroom and height and weight measurements will be taken. An IV will be placed in a forearm vein. Subjects will then be asked to lie down and they will be instrumented for baseline assessment of blood pressure and flow-mediated dilation in the popliteal artery.

Energy expenditure (EE): A ParvoMedics TrueOne2400 metabolic measurement system (Sandy Lake, UT) will be used to measure EE. The EE measurement will occur throughout the sitting period on both study visits. During the measures, a mask will be placed on their face to collect their expired air. The air will be analyzed for O2 and CO2 content. The participants will be able to breathe room air normally during the procedure. This measurement will be made prior to ingesting the glucose and periodically throughout the sitting period.

After baseline assessments, the subject will be asked to drink a 75 g glucose drink. On one occasion, subjects will then sit in a comfortable chair with minimal movement. On the second study day, subjects will sit comfortably in a chair but will continuously move their legs by fidgetting. Subjects will be allowed to move their arms (e.g., use computer or read) although not vigorously. The rationale for maintaining activity in the legs is to increase muscle blood flow and thus increase shear stress. The subject will have access to a bathroom using a wheelchair if needed. Every hour, 3 assessments of blood pressure and leg blood flow will be made while the subject remains in the sitting position. After the 4-hour sitting period, subjects will lie down again for post-sitting assessment blood pressure and flow-mediated dilation.

Following the consumption of the glucose, a small blood sample will be taken every ½ hour for 3 hours. These samples will be used to measure glucose, insulin, glucagon, and c-peptide. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03419754
Study type Interventional
Source University of Missouri-Columbia
Contact Ryan Pettit-Mee, MS
Phone 231-633-9435
Email rjpgg3@health.missouri.edu
Status Recruiting
Phase N/A
Start date March 20, 2018
Completion date January 19, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT03255005 - Endomina Controlled Study N/A
Enrolling by invitation NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT03317587 - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE) N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Active, not recruiting NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Completed NCT00341406 - Fat Cell Size in Insulin Resistance
Not yet recruiting NCT03470272 - Effects of Red Light LED Therapy on Body Contouring N/A
Not yet recruiting NCT03538236 - Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH N/A
Recruiting NCT03627104 - Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity N/A
Recruiting NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Active, not recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1
Recruiting NCT03338296 - Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years Phase 4