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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether breaking up long periods of sitting with short, frequent walking breaks (the BREAK intervention) can better control blood sugar levels compared to a single, longer walk each day. The focus is on individuals with prediabetes, where blood sugar levels are elevated but not yet high enough for a type 2 diabetes diagnosis. Participants will either take 5-minute walking breaks every hour or complete a single 45-minute walk daily, both for five days a week over three months. The study seeks individuals with prediabetes who sit for more than six hours a day and engage in less than 150 minutes of moderate exercise per week. As an Early Phase 1 trial, this research aims to understand how the BREAK intervention works in people, offering participants a chance to explore this innovative approach to managing prediabetes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking short breaks for physical activity during long periods of sitting can help control blood sugar. Studies have found that frequent light activity breaks can significantly lower blood sugar and insulin levels. This suggests that taking these breaks may manage blood sugar more effectively than doing all exercise at once.

For the BREAK intervention, which involves taking 5-minute walks every hour, specific trial evidence on its safety is not yet available. However, as this is an early phase study, the main goal is to understand basic responses, including safety. Generally, light activities like walking are safe and pose a low risk of causing problems for most people.

Considering participation in a trial with this kind of activity is likely safe, but consulting a healthcare provider for personal advice is always recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Physical Activity Breaks for Prediabetes" trial because it explores a new way of managing prediabetes through structured activity. Unlike standard treatments like dietary changes and medication, this trial tests the impact of frequent, short bouts of brisk walking throughout the day. This method, involving 5-minute walks each hour, could offer a more sustainable and less daunting approach compared to longer, continuous exercise sessions. The trial aims to determine if these regular activity breaks can effectively regulate blood sugar levels, offering a potentially game-changing, non-pharmacological option for people with prediabetes.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research shows that taking short breaks from sitting to move around can help control blood sugar levels. Studies indicate that interrupting sitting time with light exercise reduces insulin resistance, a major factor in developing type 2 diabetes. One study found that doing a little physical activity every 30 minutes effectively lowers blood sugar. This method seems to work better than one longer exercise session each day. In this trial, participants in the BREAK intervention will perform 5-minute bouts of brisk walking hourly, while those in the ONE intervention will engage in a single 45-minute continuous bout of brisk walking. Regular exercise also helps muscles use insulin better, aiding in blood sugar control. These findings suggest that short, frequent activity breaks could be a promising way to help prevent type 2 diabetes in people with prediabetes. ^{1 2 3 4 6}

Who Is on the Research Team?

Audrey Bergouignan, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6985064/

Effects of Interrupting Prolonged Sitting with Physical Activity ... Physical activity (PA) breaks in sitting time might attenuate metabolic markers relevant to the prevention of type 2 diabetes. The primary aim of this paper ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2530018022002141

Effects of break in sedentary behaviour on blood glucose ... The results show that breaks in sedentary behaviour with light physical activity in people with type 2 diabetes are effective in reducing insulin resistance.

3. bmjopensem.bmj.com bmjopensem.bmj.com/content/11/2/e002594

Can 4 weeks of real-world active breaks improve ... This study will be the first to assess the impact of breaking up sitting on glycaemic management, insulin dosage, carbohydrate intake and ...

4. mdpi.com mdpi.com/2076-3417/14/8/3201

Impact of Prolonged Sitting Interruption on Blood Glucose, ... Conclusions: According to the NMA, performing short bouts of PA every 30 min is the most effective prolonged sitting intervention for improving blood glucose ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6908414/

Physical Activity/Exercise and Diabetes: A Position ... Regular aerobic training increases muscle insulin sensitivity in individuals with prediabetes (58) and type 2 diabetes (59) in proportion to exercise volume (60) ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667036423000018

The importance of exercise for glycemic control in type 2 ... Habitual aerobic exercise helps manage blood glucose. Resistance exercise benefits insulin sensitivity in those with type 2 diabetes.