NCT05585190

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2023Dec 2027

First Submitted

Initial submission to the registry

October 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

October 15, 2022

Last Update Submit

April 28, 2026

Conditions

Keywords

Pre DiabetesObesityMetabolic SyndromeCardiovascularSit-stand deskPhysical ActivityOverweightSedentaryStanding deskInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline to 6 months

Secondary Outcomes (3)

  • HbA1c

    change from baseline to 6 months

  • fasting glucose

    change from baseline to 6 months

  • fasting insulin level

    change from baseline to 6 months

Study Arms (3)

Control

OTHER

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.

Other: Control

2-Hour Group

ACTIVE COMPARATOR

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

Other: Sit-Stand Desk at Work

3-Hour Group

ACTIVE COMPARATOR

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

Other: Sit-Stand Desk at Work

Interventions

ControlOTHER

No intervention.

Control

Subjects will receive a sit-stand desk at their work location.

2-Hour Group3-Hour Group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (2)

  • 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. doi: 10.1177/1358863X221142381.

    PMID: 33813968BACKGROUND
  • Hammad M, Shankar S, Gao Y, Kulinski J. Stand up for your health: Rationale and design for a randomized controlled trial. Contemp Clin Trials. 2026 Feb;161:108216. doi: 10.1016/j.cct.2026.108216. Epub 2026 Jan 6.

MeSH Terms

Conditions

Glucose IntoleranceObesityMetabolic SyndromeSedentary BehaviorMotor ActivityOverweightInsulin Resistance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismBehavior

Central Study Contacts

Jacquelyn Kulinski, MD

CONTACT

Ryan Kacala

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

October 15, 2022

First Posted

October 18, 2022

Study Start

February 6, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Within 1 year of completion of all studies procedures

Locations