Clinical trial NCT05585190: Stand Up for Your Health with a Sit-stand Desk
Official title: Stand Up for Your Health: a Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre Diabetes
Obesity
Metabolic Syndrome
Sedentary Behavior
Keywords: Pre Diabetes
Obesity
Metabolic Syndrome
Cardiovascular
Sit-stand desk
Physical Activity
Overweight
Sedentary
Standing desk
Insulin resistance
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

1. Overweight or obese (body mass index of 25 kg/m2 or higher)
2. 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)
3. Defined as "at-risk" for diabetes, defined as either:

   1. Prediabetes (HbA1c of 5.7% to 6.4%) or a fasting glucose of 100 to 125 mg/dL
   2. 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:

1. Established cardiovascular disease (myocardial infarction, coronary stent, coronary artery bypass grafting, cardiac transplant, or angina)
2. Established congestive heart failure or cardiomyopathy
3. Established peripheral vascular disease
4. Established diabetes (HbA1c ≥ 6.5% or on diabetes medications or insulin)
5. 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
6. Neuropathy of any etiology
7. Positional syncope or history of orthostasis
8. Less than 4 days/week at any single office (or work-from-home) location.
9. Current use of a standing desk for work
10. Tobacco use within the previous 12 months
11. Current illicit drug use or excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
12. Steroid use ≥21 days/year
13. Fasting triglyceride level ≥ 500 mg/dL
14. Thyroid disease
15. Uncontrolled or untreated hypertension(\>150/90 mm Hg)
16. Pregnant or lactating (or plans to become pregnant in the next 6 months)
17. LDL cholesterol ≥ 190mg/dL
18. Currently enrolled or plans to diet or join a weight loss program over the next 6 months.
19. Non-English speaker

Primary outcomes:
measure: Insulin sensitivity (HOMA-IR)
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: change from baseline to 6 months
measure: fasting glucose
timeFrame: change from baseline to 6 months
measure: fasting insulin level
timeFrame: change from baseline to 6 months
measure: metabolic syndrome severity (MetS) score
timeFrame: change from baseline to 6 months
measure: metabolic syndrome
timeFrame: change from baseline to 6 months
measure: fasting triglycerides
timeFrame: change from baseline to 6 months
measure: very low-density lipoprotein (VLDL) particle number
timeFrame: change from baseline to 6 months
measure: vascular endothelial function (superficial femoral artery)
timeFrame: change from baseline to 6 months
Other outcomes:
measure: Acceptability Questionnaire
timeFrame: 6 months
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Bodker A, Visotcky A, Gutterman D, Widlansky ME, Kulinski J. The impact of standing desks on cardiometabolic and vascular health. Vasc Med. 2021 Aug;26(4):374-382. doi: 10.1177/1358863X211001934. Epub 2021 Apr 5.