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Clinical Trials/NCT05585190
NCT05585190
Recruiting
Not Applicable

Stand Up for Your Health: a Randomized Study

Medical College of Wisconsin1 site in 1 country198 target enrollmentFebruary 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre Diabetes
Sponsor
Medical College of Wisconsin
Enrollment
198
Locations
1
Primary Endpoint
Insulin sensitivity (HOMA-IR)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
February 6, 2023
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jacquelyn Kulinski

Principal Investigator, Associate Professor

Medical College of Wisconsin

Eligibility Criteria

Inclusion Criteria

  • Overweight or obese (body mass index of 25 kg/m2 or higher)
  • Employees with "sedentary" jobs, defined as spending at least 75% of their (8 hours or more) workday sitting at a desk (at home or in an office)
  • Defined as "at-risk" for diabetes, defined as either:
  • Prediabetes (HbA1c of 5.7% to 6.4%) or a fasting glucose of 100 to 125 mg/dL
  • Having one or more additional risk factors: (beyond BMI\>25)
  • Age 45 years or older
  • Family history of diabetes mellitus in a first-degree relative
  • Physical inactivity (no structured exercise activity)
  • History of gestational diabetes, hypertension, or dyslipidemia
  • African American, Alaska Native, American Indian, Asian American, Hispanic/Latino, Native Hawaiian, or Pacific Islander ethnicity

Exclusion Criteria

  • Established cardiovascular disease (myocardial infarction, coronary stent, coronary artery bypass grafting, cardiac transplant, or angina)
  • Established congestive heart failure or cardiomyopathy
  • Established peripheral vascular disease
  • Established diabetes (HbA1c ≥ 6.5% or on diabetes medications or insulin)
  • Chronic musculoskeletal disorders involving the lower extremities, such as arthritis of the knees or hips, or regular use of ambulatory assist devices such as a walker or cane
  • Neuropathy of any etiology
  • Positional syncope or history of orthostasis
  • Less than 4 days/week at any single office (or work-from-home) location.
  • Current use of a standing desk for work
  • Tobacco use within the previous 12 months

Outcomes

Primary Outcomes

Insulin sensitivity (HOMA-IR)

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.

Secondary Outcomes

  • HbA1c(change from baseline to 6 months)
  • fasting glucose(change from baseline to 6 months)
  • fasting insulin level(change from baseline to 6 months)
  • metabolic syndrome severity (MetS) score(change from baseline to 6 months)
  • metabolic syndrome(change from baseline to 6 months)
  • fasting triglycerides(change from baseline to 6 months)
  • very low-density lipoprotein (VLDL) particle number(change from baseline to 6 months)
  • vascular endothelial function (superficial femoral artery)(change from baseline to 6 months)

Study Sites (1)

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