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Stand up for Your Health With a Sit-stand Desk

Primary Purpose

Pre Diabetes, Obesity, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
2-Hour Stand Group
3-Hour Stand Group
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes focused on measuring Pre Diabetes, Obesity, Metabolic Syndrome, Cardiovascular, Sit-stand desk, Physical Activity, Overweight, Sedentary, Standing desk, Insulin resistance

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Overweight or obese (body mass index > 25 kg/m2)
  2. An employee of the Medical College of Wisconsin 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

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Control

2-Hour Group

3-Hour Group

Arm Description

Subjects will not receive a sit/stand desk for the duration of the study and will be asked to follow their normal work day routine.

Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 2 hours each work day.

Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 3 hours each work day.

Outcomes

Primary Outcome Measures

Insulin sensitivity (HOMA-IR)
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 Outcome Measures

HbA1c, fasting glucose, fasting insulin
Determine if use of a sit-stand desk improves insulin sensitivity.
metabolic syndrome and metabolic syndrome severity (MetS) score
Determine if use of a sit-stand desk at work improves metabolic health, as assessed by number of (NCEP ATP III) metabolic syndrome criteria and MetS severity score, in sedentary office workers at-risk for type 2 diabetes mellitus.
fasting triglycerides, very low density lipoprotein (VLDL)
To quantify changes in serum fasting triglyceride levels and triglyceride-rich, remnant lipoproteins with the sit-stand desk (compared to no desk), while accounting for dietary intake.
vascular endothelial function (superficial femoral and brachial arteries) and resilience to a high-glucose load
To measure the changes in vascular endothelial function with the sit-stand desk compared to control.

Full Information

First Posted
October 15, 2022
Last Updated
May 5, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT05585190
Brief Title
Stand up for Your Health With a Sit-stand Desk
Official Title
Stand Up for Your Health: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Subjects will not receive a sit/stand desk for the duration of the study and will be asked to follow their normal work day routine.
Arm Title
2-Hour Group
Arm Type
Active Comparator
Arm Description
Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 2 hours each work day.
Arm Title
3-Hour Group
Arm Type
Active Comparator
Arm Description
Sit-stand desk intervention group, subjects are asked to maintain the desk in the standing position at LEAST 3 hours each work day.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention.
Intervention Type
Other
Intervention Name(s)
2-Hour Stand Group
Intervention Description
Subjects will also receive a weekly email/text reminding them to maintain the desk in the standing position at LEAST 2 hours each work day.
Intervention Type
Other
Intervention Name(s)
3-Hour Stand Group
Intervention Description
Subjects will also receive a weekly email/text reminding them to maintain the desk in the standing position at LEAST 3 hours each work day.
Primary Outcome Measure Information:
Title
Insulin sensitivity (HOMA-IR)
Description
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
baseline to 6 months and baseline to 3 months changes
Secondary Outcome Measure Information:
Title
HbA1c, fasting glucose, fasting insulin
Description
Determine if use of a sit-stand desk improves insulin sensitivity.
Time Frame
baseline to 6 months and baseline to 3 months changes
Title
metabolic syndrome and metabolic syndrome severity (MetS) score
Description
Determine if use of a sit-stand desk at work improves metabolic health, as assessed by number of (NCEP ATP III) metabolic syndrome criteria and MetS severity score, in sedentary office workers at-risk for type 2 diabetes mellitus.
Time Frame
baseline to 6 months and baseline to 3 months changes
Title
fasting triglycerides, very low density lipoprotein (VLDL)
Description
To quantify changes in serum fasting triglyceride levels and triglyceride-rich, remnant lipoproteins with the sit-stand desk (compared to no desk), while accounting for dietary intake.
Time Frame
baseline to 6 months and baseline to 3 months changes
Title
vascular endothelial function (superficial femoral and brachial arteries) and resilience to a high-glucose load
Description
To measure the changes in vascular endothelial function with the sit-stand desk compared to control.
Time Frame
baseline to 6 months and baseline to 3 months changes
Other Pre-specified Outcome Measures:
Title
free fatty acids
Description
Measure the impact of the sit-stand desk on changes in fasting serum free fatty acids (FFAs) and correlate with changes in endothelial function.
Time Frame
baseline to 6 months and baseline to 3 months changes
Title
Acceptability Questionnaire
Description
Includes questions on ease of use, comfort, perceived work productivity, and musculoskeletal discomforts related to use of the sit-stand desk. Higher scores are more favorable.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Overweight or obese (body mass index > 25 kg/m2) An employee of the Medical College of Wisconsin 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 Current illicit drug use or excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men) Steroid use ≥21 days/year Fasting triglyceride level ≥ 500 mg/dL Thyroid disease Uncontrolled or untreated hypertension(>150/90 mm Hg) Pregnant or lactating (or plans to become pregnant in the next 6 months) LDL cholesterol ≥ 190mg/dL Currently enrolled or plans to diet or join a weight loss program over the next 6 months. Non-English speaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquelyn Kulinski, MD
Phone
414-955-6896
Email
jakulinski@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Kacala
Phone
414-955-6885
Email
rkacala@mcw.edu
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquelyn P Kulinski, MD
Phone
414-955-6896
Email
jakulinski@mcw.edu
First Name & Middle Initial & Last Name & Degree
Ryan Kacala
Phone
414-955-6885
Email
rkacala@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Within 1 year of completion of all studies procedures
Citations:
PubMed Identifier
33813968
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. Erratum In: Vasc Med. 2023 Feb;28(1):NP1.
Results Reference
background

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Stand up for Your Health With a Sit-stand Desk

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