Pre-diabetesEarly Phase 1BURST2DNCT05041491
Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
A Early Phase 1 study testing BREAK and ONE in people with Pre-diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- BREAK and ONE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 30 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association criteria for pre-diabetes. Fasting glucose, HbA1c and OGTT results ordered by the participant's provider within 3-months of the screening visit will be accepted, provided they fall within the measurement of error range established by the institution's lab standards. Additionally, consistent use of Metformin (1 year) to prevent prediabetes from developing diabetes will be accepted.
- Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by the volunteers using the International Physical Activity Questionnaire (IPAQ).
- Less than 6500 of steps per day as measured by a pedometer over 5 days (at least 1 weekend day).
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- Passing medical and physical screening, and analysis of blood and urine screening samples.
- Low-moderate caffeine use (<3 cups/day).
- Agree to refrain from any other structured exercise than the physical activity prescribed in each arm of the study.
- Agree to eat control diets for 3 days before and during the Clinical and Translational Research Center (CTRC) visits;
- Agree to refrain from taking any over-the-counter (including nonsteroidal anti-inflammatory drugs) or prescribed medication (apart from oral contraceptives) for 3 days prior to the inpatient CTRC visits;
- Agree to wear a Fitbit® activity monitor and upload data on the website on a daily basis for the whole duration of the study.
- Agree to follow the physical activity interventions and to be randomly assigned to one of the two arms of the study.
- Agree to complete all the study procedures.
Who cannot join
- Pregnancy, breast-feeding or post-menopause for women.
- Being considered unsafe to participate as determined by the study physician.
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism.
- Being positive for human immunodeficiency virus or hepatitis B or C.
- Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months.
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- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician.
- Being a smoker or having been a smoker in the 3 months prior to their screening visit.
- Having donated over 400 mL of blood within 3 months (90 days) of screening for the study;
- Working night shifts within 1 month of and throughout the study.
- Not completing the trial days of BREAK and ONE during the screening period to assess the willingness and ability of the participant to perform each of the interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Audrey Bergouignan, PhD
About this study
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
- Pre-diabetes
- Being tested
- BREAK, ONE
- Keywords
- sedentary behavior, physical activity, glucose control, metabolism, pre-diabetes
- Medical subject headings
- Glucose Intolerance, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREAKBehavioural
The BREAK intervention is a physical activity regimen.
ONEBehavioural
The ONE intervention is a physical activity regimen.
| Study group | Role | What they receive |
|---|---|---|
| BREAK Intervention | Experimental | Participants in the BREAK condition will perform 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week for 3 months. Receives: Behavioral: BREAK |
| ONE Intervention | Active comparator | Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months. Receives: Behavioral: ONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia
Plasma glucose concentration in mg/dL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).
Measured: Glucose concentration in mg/dl, measured at fasting, during a 2 hour OGTT and after
Secondary outcomes (20)
Insulinemia
Plasma insulin concentration in milli-international units per milliliter (mUI/mL) measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).
Measured: Plasma insulin concentration in mUI/mL, measured at fasting, during a 2 hour OGTT and after
Mean interstitial glucose concentration
Mean interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep for 24hours for 10 days.
Measured: Before and after 1 month and 3 months of intervention
Daily glycemia variability
Standard deviation (SD) of interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep 24hours throughout 10 days.
Measured: Before and after 1 month and 3 months of intervention
Fasting A1c concentration
Fasting A1c concentration expressed in %
Measured: Time Frame: Before and after 1 month and 3 months of intervention
Fasting fructosamine concentration
Fasting fructosamine concentration in umol/L
Measured: Before and after 1 month and 3 months of intervention
12-hour exogenous glucose oxidation
Rates of carbon-13 (13C) recovery (% of the dose) in expired carbon dioxide (CO2) following the ingestion of U-13C-glucose in both breakfast and lunch meals.
Measured: Before and after 1 month of intervention
12-hour endogenous glucose oxidation
Rates of D2 recovery (% of the dose) in expired urines following the infusion of (2,2H2) glucose.
Measured: Before and after 1 month of intervention
12 hour CO2 production
CO2 production measured by indirect calorimetry (ParvoMedics TrueOne® 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.
Measured: Before and after 1 month of intervention
12 hour O2 production
O2 production measured by indirect calorimetry (ParvoMedics TrueOne 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.
Measured: Before and after 1 month of intervention
12 Urine excretion
Urine will be measured every hour from 0730h to 1830h
Measured: Before and after 1 month of intervention
Glucose kinetics
Steele's equation for non-steady-state will be used to compute rate of appearance of total glucose (RaT) and rate of appearance of exogenous glucose (RaE), as well as the rates of disappearance (RdT and RdE) from the percentage of [6,6-2H2]glucose6 and of 13C-glucose in plasma glucose61. Endogenous glucose production (EGP) will be computed as RaT-RaE. Nonoxidative glucose disposal (NOGD) will be calculated by subtracting total carbohydrate oxidation from (RdT + RdE). Plasma glucose utilization will be assumed to be equivalent to RdT as has been confirmed previously. Muscle glycogen utilization during the active period will be calculated as total carbohydrate utilization during exercise minus plasma glucose utilization during exercise.
Measured: Before and after 1 month of intervention
Fasting and postprandial glucose
Fasting and postprandial glucose in mg/dl measured in response to standard lunch
Measured: Before and after 1 month of intervention
Fasting and postprandial insulin
Fasting and postprandial insulin in ml/iu measured in response to standard lunch
Measured: Before and after 1 month of intervention
Fasting and postprandial C-Peptide
Fasting and postprandial C-peptide nmol/mL measured in response to standard lunch
Measured: Before and after 1 month of intervention
Fasting and postprandial glucagon
Fasting and postprandial glucagon in pg/mL measured in response to standard lunch
Measured: Before and after 1 month of intervention
Fasting and postprandial catecholamines
Fasting and postprandial catecholamines in pg/mL measured in response to standard lunch
Measured: Before and after 1 month of intervention
Skeletal muscle content of protein kinase B (Akt) (Aktser473/total)
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure protein kinase B (Akt) (Aktser473/total) using western blotting.
Measured: Before and after 1 month of intervention
Skeletal muscle content of ACC (ACCS79/ total)
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure ACC (ACCS79/ total) using western blotting.
Measured: Before and after 1 month of intervention
Skeletal muscle content of TBC1D4 (AS160/ total)
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure TBC1D4 (AS160/ total) using western blotting.
Measured: Before and after 1 month of intervention
Skeletal muscle content of COX4
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure citrate synthase (COX4) using western blotting.
Measured: Before and after 1 month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start30 Nov 2021
- Primary completion15 May 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the BREAK condition (5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/wk) or the ONE condition (45-min of brisk walking performed as a single continuous bout, 5 days/wk) for 3 months. Participants will complete all study visits in only one group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Bergouignan, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041491
- Sponsor's protocol ID
- 20-1900
- Acronym
- BURST2D
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2021
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05041491
- Acronym / sponsor ID
- BURST2D / 20-1900
- Conditions
- Pre-diabetes
- Keywords
- sedentary behavior, physical activity, glucose control, metabolism, pre-diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the BREAK condition (5-min bouts of brisk walking performed hourly for 9 hours/day, 5 days/wk) or the ONE condition (45-min of brisk walking performed as a single continuous bout, 5 days/wk) for 3 months. Participants will complete all study visits in only one group.
| Arm | Type | Receives |
|---|---|---|
| BREAK Intervention | Experimental | Behavioral: BREAKParticipants in the BREAK condition will perform 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week for 3 months. |
| ONE Intervention | Active comparator | Behavioral: ONEParticipants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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 of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association criteria for pre-diabetes. Fasting glucose, HbA1c and OGTT results ordered by the participant's provider within 3-months of the screening visit will be accepted, provided they fall within the measurement of error range established by the institution's lab standards. Additionally, consistent use of Metformin (1 year) to prevent prediabetes from developing diabetes will be accepted.
- Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by the volunteers using the International Physical Activity Questionnaire (IPAQ).
Key exclusion criteria (11 listed)
- Pregnancy, breast-feeding or post-menopause for women.
- Being considered unsafe to participate as determined by the study physician.
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism.
- Being positive for human immunodeficiency virus or hepatitis B or C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREAKThe BREAK intervention is a physical activity regimen. | Behavioural | BREAK Intervention |
| ONEThe ONE intervention is a physical activity regimen. | Behavioural | ONE Intervention |
Primary outcome
Glycemia
Time frame: Glucose concentration in mg/dl, measured at fasting, during a 2 hour OGTT and after
Plasma glucose concentration in mg/dL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).
20 secondary outcomes
Insulinemia
Time frame: Plasma insulin concentration in mUI/mL, measured at fasting, during a 2 hour OGTT and after
Mean interstitial glucose concentration
Time frame: Before and after 1 month and 3 months of intervention
Daily glycemia variability
Time frame: Before and after 1 month and 3 months of intervention
Fasting A1c concentration
Time frame: Time Frame: Before and after 1 month and 3 months of intervention
Fasting fructosamine concentration
Time frame: Before and after 1 month and 3 months of intervention
12-hour exogenous glucose oxidation
Time frame: Before and after 1 month of intervention
12-hour endogenous glucose oxidation
Time frame: Before and after 1 month of intervention
12 hour CO2 production
Time frame: Before and after 1 month of intervention
12 hour O2 production
Time frame: Before and after 1 month of intervention
12 Urine excretion
Time frame: Before and after 1 month of intervention
Glucose kinetics
Time frame: Before and after 1 month of intervention
Fasting and postprandial glucose
Time frame: Before and after 1 month of intervention
Fasting and postprandial insulin
Time frame: Before and after 1 month of intervention
Fasting and postprandial C-Peptide
Time frame: Before and after 1 month of intervention
Fasting and postprandial glucagon
Time frame: Before and after 1 month of intervention
Fasting and postprandial catecholamines
Time frame: Before and after 1 month of intervention
Skeletal muscle content of protein kinase B (Akt) (Aktser473/total)
Time frame: Before and after 1 month of intervention
Skeletal muscle content of ACC (ACCS79/ total)
Time frame: Before and after 1 month of intervention
Skeletal muscle content of TBC1D4 (AS160/ total)
Time frame: Before and after 1 month of intervention
Skeletal muscle content of COX4
Time frame: Before and after 1 month of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey Bergouignan, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BREAK and ONE in people with Pre-diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Smith, MS, RDN (303.724.6821, trish.smith@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemia (time frame: Glucose concentration in mg/dl, measured at fasting, during a 2 hour OGTT and after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.