Physical Activity Breaks for Prediabetes

(BURST2D Trial)

Overseen By Patricia Smith, MS, RDN

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must not be taking: Weight, Triglycerides, Energy, Sleep

Disqualifiers: Pregnancy, Cardiovascular, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You will need to stop taking any over-the-counter or prescribed medications (except oral contraceptives) for 3 days before certain study visits. The trial does not specify if you need to stop taking your medications for the entire study duration.

What data supports the effectiveness of the treatment BREAK for prediabetes?

Research shows that increasing physical activity can help prevent the progression from prediabetes to diabetes and improve heart health. Studies have found that people with higher levels of physical activity are less likely to have prediabetes, and lifestyle changes that include exercise can reduce the risk of developing type 2 diabetes. ^{1 2 3 4 5}

Is it safe for humans to participate in physical activity breaks for prediabetes?

Physical activity is generally safe for people with prediabetes, though there are some mild to severe risks like muscle injuries or low blood sugar. These risks are low, and with proper precautions, physical activity can be safely increased. ^{1 2 4 6 7}

How does the BREAK treatment for prediabetes differ from other treatments?

The BREAK treatment is unique because it focuses on incorporating physical activity breaks into daily routines, which can help manage blood sugar levels and reduce the risk of developing type 2 diabetes. Unlike other treatments that may emphasize diet or medication, this approach specifically targets reducing sedentary behavior and increasing physical activity as a primary intervention. ^{1 2 3 4 6}

Research Team

Audrey Bergouignan, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for sedentary adults aged 18-64 with prediabetes, defined by specific glucose levels. Participants should have a BMI of 18.5-40, be non-smokers, and not on medications that affect weight or metabolism. They must do less than 150 minutes of exercise weekly and sit for over 6 hours daily.

Inclusion Criteria

Agree to refrain from any other structured exercise than the physical activity prescribed in each arm of the study

My BMI is between 18.5 and 40, and my weight has been stable for the last 6 months.

Agree to complete all the study procedures

Exclusion Criteria

Being considered unsafe to participate as determined by the study physician

You smoke or have smoked in the last 3 months before the screening visit.

You have given more than about 1.7 cups of blood in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the BREAK or ONE intervention for 3 months

12 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BREAK
• ONE

Trial Overview The study tests if short bursts of physical activity (5-min brisk walks hourly) are more effective in controlling blood sugar than one long walk daily in people at risk for type 2 diabetes. Both groups will perform their assigned activities five days a week for three months.

Participant Groups

Group I: BREAK Intervention Experimental Treatment 1 Intervention

Participants in the BREAK condition will perform 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week for 3 months.

Group II: ONE Intervention Active Control 1 Intervention

Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a study of 1,317 US adults, those in the highest tertile of physical activity had a lower prevalence of pre-diabetes (PD) compared to those in the lowest tertile, suggesting that higher physical activity may be protective against PD.

However, when adjusting for age and body mass index (BMI), the association between physical activity and pre-diabetes prevalence was no longer significant, indicating that age and BMI may confound the relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and pre-diabetes-an unacknowledged mid-life crisis: findings from NHANES 2003-2006. Farni, K., Shoham, DA., Cao, G., et al.[2021]

Lifestyle interventions, particularly increased physical activity, can prevent the progression from pre-diabetes to Type 2 diabetes and improve cardiovascular risk factors, as shown in various studies reviewed.

One recent trial indicated that such interventions may directly reduce cardiovascular events, including mortality, strokes, and heart attacks, highlighting the potential of physical activity in managing health risks for pre-diabetic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance. Popp Switzer, M., Elhanafi, S., San Juan, ZT.[2018]

Lifestyle modifications, including both diet and exercise, are effective in reducing the risk of developing type 2 diabetes (T2D) and improving blood sugar control in adults with prediabetes, even without significant weight loss.

The specific contributions of diet or exercise alone to glycemic control and weight loss in prediabetes remain unclear, indicating a need for further research to determine the most effective strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent and combined effect of diet and exercise in adults with prediabetes. Sénéchal, M., Slaght, J., Bharti, N., et al.[2022]

A systematic review of 47 studies involving over 8000 individuals with prediabetes or diabetes found that while there are some risks associated with increased physical activity, such as musculoskeletal injuries and hypoglycemia, the overall prevalence of severe adverse events is low.

The review supports that increased physical activity is generally safe for individuals with prediabetes and diabetes, and it led to the development of a new risk assessment algorithm to help guide safe exercise practices for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: diabetes mellitus and related comorbidities. Riddell, MC., Burr, J.[2022]

In a study of 113 elderly patients with prediabetes who completed a 2-year exercise intervention, factors such as baseline β-cell function, hemoglobin A1c levels, and body mass index were identified as significant predictors of whether participants would convert to diabetes or revert to normal glucose tolerance.

The type of exercise (aerobic vs. resistance) did not significantly impact the exercise response, suggesting that individual metabolic factors are more critical in determining the effectiveness of exercise in preventing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Cell function and body mass index are predictors of exercise response in elderly patients with prediabetes. He, Y., Feng, Y., Shi, J., et al.[2022]

The study identified a four-stage process that individuals with prediabetes go through when developing exercise habits, starting from awareness and culminating in spontaneous regular exercise, highlighting the challenges they face in maintaining a routine.

Participants experienced an 'action cycle of internal struggle,' indicating that both motivating and resisting factors influence their ability to continue or discontinue exercise, which can inform healthcare providers in creating supportive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise engagement in people with prediabetes--a qualitative study. Kuo, YL., Wu, SC., Hayter, M., et al.[2018]

In a study of 4,481 U.S. adults, engaging in physical activity (PA) at work and during recreation was associated with a lower prevalence of prediabetes, with rates around 24% and 21% respectively, compared to 27-30% in inactive individuals.

Lack of recreational physical activity significantly increased the risk of prediabetes, with an odds ratio of 1.26, indicating that being physically active in leisure time is crucial for reducing prediabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Work and Recreational Physical Activity on Prediabetes Condition among U.S. Adults: NHANES 2015-2016. Pazmino, L., Esparza, W., Aladro-Gonzalvo, AR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical activity and pre-diabetes-an unacknowledged mid-life crisis: findings from NHANES 2003-2006. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Independent and combined effect of diet and exercise in adults with prediabetes. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: diabetes mellitus and related comorbidities. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

β-Cell function and body mass index are predictors of exercise response in elderly patients with prediabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Exercise engagement in people with prediabetes--a qualitative study. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Work and Recreational Physical Activity on Prediabetes Condition among U.S. Adults: NHANES 2015-2016. [2021]