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Physical Activity Breaks for Prediabetes (BURST2D Trial)
Phase < 1
Recruiting
Led By Audrey Bergouignan, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI of 18.5-40 kg/m2 and weight stable over the previous 6 months
Age, 18-64 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 1 month of intervention
Awards & highlights
BURST2D Trial Summary
This trial will study whether frequently interrupting sedentary time by performing multiple short bouts of physical activity throughout the day improves glycemia more than performing a single continuous bout of physical activity in sedentary men and women with overweight or obesity and prediabetes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve moderate physical activity, potential side effects may include muscle soreness, fatigue, or minor injuries related to walking. However, these are generally mild and common when starting a new exercise routine.
BURST2D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 18.5 and 40, and my weight has been stable for the last 6 months.
Select...
I am between 18 and 64 years old.
Select...
I walk less than 6500 steps a day, as tracked for 5 days.
Select...
I walk less than 6500 steps a day, as tracked for 5 days.
Select...
My blood sugar levels indicate I have pre-diabetes.
BURST2D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: before and after 1 month and 3 months of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: before and after 1 month and 3 months of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemia
Secondary outcome measures
12 Urine excretion
12 hour CO2 production
12 hour O2 production
+17 moreBURST2D Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BREAK InterventionExperimental Treatment1 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 InterventionActive Control1 Intervention
Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,737 Previous Clinical Trials
2,149,240 Total Patients Enrolled
Audrey Bergouignan, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is between 18.5 and 40, and my weight has been stable for the last 6 months.I am between 18 and 64 years old.You don't exercise much and spend a lot of time sitting, according to what you tell us.I walk less than 6500 steps a day, as tracked for 5 days.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.I agree not to take any medication except for birth control pills 3 days before my visit.I am pregnant, breastfeeding, or have gone through menopause.You have a history of serious mental or neurological illness, or drug and alcohol abuse.I have a history of heart disease, diabetes, high blood pressure, thyroid, kidney, liver diseases, high cholesterol, or any condition affecting my weight or cholesterol levels.I completed the trial tasks during the screening.I have passed all required medical and physical screenings, including blood and urine tests.I am positive for HIV or hepatitis B/C.I have not taken medication affecting my weight, energy, or sleep in the last 3 months.I walk less than 6500 steps a day, as tracked for 5 days.My blood sugar levels indicate I have pre-diabetes.You don't exercise much and you sit for a long time each day, according to what you tell us.You drink less than three cups of coffee a day.I have not worked night shifts or traveled across more than 2 time zones within the last month and won't throughout the study.Your blood tests show significant abnormalities as determined by the study doctor.I agree to follow the study's exercise plan and accept random assignment.I am either male or female.You drink less than three cups of coffee per day.
Research Study Groups:
This trial has the following groups:- Group 1: ONE Intervention
- Group 2: BREAK Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the recruitment size for this clinical trial?
"Affirmative, as detailed on clinicaltrials.gov this medical study is actively seeking participants. It was first made available to the public on October 25th 2021 and has since been updated on November 2nd 2021. 66 individuals need to be enrolled from 1 particular site for full completion of the trial."
Answered by AI
Are individuals over twenty-five years of age eligible for this research endeavor?
"The prerequisites for this trial necessitate that the patient be between 18 to 45 years old. Conversely, there are 241 medical studies available for minors and 1,159 trials suitable for seniors."
Answered by AI
Can new participants join this research endeavor?
"Affirmative. According to the information posted on clinicaltrials.gov, this medical study remains open and is looking for 66 participants at a single site since it was first promoted on October 25th 2021 and last updated November 2nd 2021."
Answered by AI
To whom does this clinical trial open its doors?
"To be eligible to join this trial, subjects must meet two criteria: they should have diabetes mellitus and must fall within the age range of 18-45. At present, 66 people are needed for full enrollment."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
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