Actively Recruiting
Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
Led by University of Colorado, Denver · Updated on 2025-07-29
66
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Newly released guidelines recommend increased physical activity (PA) and reduced sedentary behaviors (SB) to improve glycemia and prevent the onset and progression of type 2 diabetes (T2D). Typically, 30-60 min bouts of PA are advocated per day. Although this approach increases PA, it does not decrease the length of the sedentary periods through the day. This is important because recent epidemiological data suggest that frequently interrupting sedentary time improves glucose control even in people who achieve the recommended levels of PA. Preliminary experimental data suggest that breaking up prolonged sedentary time by performing multiple short bouts (5 min) of PA throughout the day, may improve glycemia more than performing a single continuous bout of PA, and thereby potentially be a novel strategy to prevent T2D. The improvement in glycemia was observed even when the total amount of PA and total energy expenditure were matched, suggesting that how and when PA is performed over the day may matter more than how much PA is done. However, important gaps in knowledge remain including: (1) whether similar benefits on glucose control would be observed in adults with prediabetes, a clinically relevant population that is at high risk of developing T2D; (2) whether these effects are sustained or diluted over time, and (3) what are the mechanistic underpinnings. To address these gaps, the investigators propose to measure the acute and chronic effects of PA breaks on glucose control and the underlying mechanisms in individuals at risk of developing T2D. Sedentary men and women with prediabetes (n=66, 50% F) will be randomized to either an intervention designed to interrupt SB with 5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/week (BREAK) or a control condition consisting of 45-min of brisk walking performed as a single daily continuous bout, 5 days/week (ONE). The two 3-months interventions will be matched for total active time.
CONDITIONS
Official Title
Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female
- BMI of 18.5-40 kg/m2 and weight stable over the previous 6 months
- Age 18-64 years old
- Fasting glucose 100-125 mg/dL or fasting HbA1c 5.7-6.4%, or 2-hour OGTT blood glucose 140-199 mg/dL within 3 months prior to screening
- Consistent use of Metformin for 1 year to prevent diabetes is accepted
- Less than 150 minutes of moderate-to-vigorous physical activity per week and more than 6 hours of sitting time per day by self-report
- Less than 6500 steps per day measured by pedometer over 5 days (including 1 weekend day)
- Passing medical and physical screening and blood and urine tests
- Low to moderate caffeine use (fewer than 3 cups per day)
- Agree to avoid other structured exercise besides study interventions
- Agree to eat control diets for 3 days before and during clinical visits
- Agree to refrain from over-the-counter or prescribed medications (except oral contraceptives) for 3 days before inpatient visits
- Agree to wear a Fitbit activity monitor and upload data daily during the study
- Agree to follow assigned physical activity intervention
- Agree to complete all study procedures
You will not qualify if you...
- Pregnancy, breastfeeding, or post-menopause for women
- Unsafe to participate as judged by study physician
- History of systemic, psychiatric, neurological disease, or drug and alcohol abuse
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, kidney or liver disease, dyslipidemia, or other conditions affecting weight or lipid metabolism
- Positive for HIV or hepatitis B or C
- Use of medications affecting weight, triglycerides, energy intake or expenditure, or sleep in past 3 months
- Abnormal blood chemistry or hematology considered significant by study physician
- Current smoker or smoked within 3 months prior to screening
- Donated more than 400 mL blood within 3 months prior to screening
- Working night shifts within 1 month before and during the study
- Failure to complete screening trial days of both physical activity interventions
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
P
Patricia Smith, MS, RDN
CONTACT
A
Audrey Bergouignan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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