Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Location status: Recruiting
Location contact
Jacquelyn P Kulinski, MD
CONTACT
Ryan Kacala
CONTACT
NCT Number: NCT05585190
More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial.
The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses.
The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).
Interested in participating?
Request Info18 year–79 year
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
Location status: Recruiting
Jacquelyn P Kulinski, MD
CONTACT
Ryan Kacala
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention.
Subjects will receive a sit-stand desk at their work location.
Time frame: change from baseline to 6 months
Determine if use of a sit-stand desk improves insulin sensitivity and ascertain if there is a dose-response relationship with changes in sedentary time.
Time frame: change from baseline to 6 months
Determine if use of a sit-stand desk improves HbA1c.
Time frame: change from baseline to 6 months
Determine if use of a sit-stand desk improves fasting glucose.
Time frame: change from baseline to 6 months
Determine if use of a sit-stand desk improves (reduces) fasting insulin levels.
Contact information is provided by the study sponsor or research team.
Jacquelyn Kulinski, MD
CONTACT
Ryan Kacala
CONTACT
Medical College of Wisconsin
Other
Stand Up for Your Health: A Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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