RecruitingEarly Phase 1NCT05041491

Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes


Sponsor

University of Colorado, Denver

Enrollment

66 participants

Start Date

Nov 30, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether regularly breaking up long periods of sitting with short movement breaks can improve blood sugar control in people who have prediabetes or are at risk of developing type 2 diabetes. **You may be eligible if...** - You are between 18 and 64 years old - Your BMI is between 18.5 and 40 kg/m² and your weight has been stable for the past 6 months - You have been diagnosed with prediabetes (fasting blood sugar 100–125 mg/dL, HbA1c 5.7–6.4%, or borderline 2-hour glucose test result) - You currently sit for more than 6 hours a day and get less than 150 minutes of moderate exercise per week **You may NOT be eligible if...** - You are pregnant or planning to become pregnant during the study - You have type 1 or type 2 diabetes - You have physical limitations that prevent you from standing or walking - You have a condition that would make increased physical activity unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBREAK

The BREAK intervention is a physical activity regimen.

BEHAVIORALONE

The ONE intervention is a physical activity regimen.


Locations(1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

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NCT05041491


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