Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes (BURST2D)

July 24, 2025 updated by: University of Colorado, Denver
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Audrey Bergouignan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BREAK 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.
Behavioral: BREAK
The BREAK intervention is a physical activity regimen.
Active Comparator: ONE Intervention
Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months.
Behavioral: ONE
The ONE intervention is a physical activity regimen.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Glucose concentration in mg/dl, measured at fasting, during a 2 hour OGTT and after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean interstitial glucose concentration
Time Frame: Before and after 1 month and 3 months of intervention
Mean interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep for 24hours for 10 days.
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
Standard deviation (SD) of interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep 24hours throughout 10 days.
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 A1c concentration expressed in %
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
Fasting fructosamine concentration in umol/L
Before and after 1 month and 3 months of intervention
12-hour endogenous glucose oxidation
Time Frame: Before and after 1 month of intervention
Rates of D2 recovery (% of the dose) in expired urines following the infusion of (2,2H2) glucose.
Before and after 1 month of intervention
12 hour O2 production
Time Frame: Before and after 1 month of intervention
O2 production measured by indirect calorimetry (ParvoMedics TrueOne 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.
Before and after 1 month of intervention
12 Urine excretion
Time Frame: Before and after 1 month of intervention
Urine will be measured every hour from 0730h to 1830h
Before and after 1 month of intervention
Fasting and postprandial glucose
Time Frame: Before and after 1 month of intervention
Fasting and postprandial glucose in mg/dl measured in response to standard lunch
Before and after 1 month of intervention
Fasting and postprandial insulin
Time Frame: Before and after 1 month of intervention
Fasting and postprandial insulin in ml/iu measured in response to standard lunch
Before and after 1 month of intervention
Fasting and postprandial C-Peptide
Time Frame: Before and after 1 month of intervention
Fasting and postprandial C-peptide nmol/mL measured in response to standard lunch
Before and after 1 month of intervention
Fasting and postprandial glucagon
Time Frame: Before and after 1 month of intervention
Fasting and postprandial glucagon in pg/mL measured in response to standard lunch
Before and after 1 month of intervention
Fasting and postprandial catecholamines
Time Frame: Before and after 1 month of intervention
Fasting and postprandial catecholamines in pg/mL measured in response to standard lunch
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
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.
Before and after 1 month of intervention
Skeletal muscle content of ACC (ACCS79/ total)
Time Frame: Before and after 1 month of intervention
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.
Before and after 1 month of intervention
Skeletal muscle content of TBC1D4 (AS160/ total)
Time Frame: Before and after 1 month of intervention
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.
Before and after 1 month of intervention
Insulinemia
Time Frame: Plasma insulin concentration in mUI/mL, measured at fasting, during a 2 hour OGTT and after
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).
Plasma insulin concentration in mUI/mL, measured at fasting, during a 2 hour OGTT and after
12-hour exogenous glucose oxidation
Time Frame: Before and after 1 month of intervention
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.
Before and after 1 month of intervention
12 hour CO2 production
Time Frame: Before and after 1 month of intervention
CO2 production measured by indirect calorimetry (ParvoMedics TrueOne® 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.
Before and after 1 month of intervention
Glucose kinetics
Time Frame: Before and after 1 month of intervention
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.
Before and after 1 month of intervention
Skeletal muscle content of COX4
Time Frame: Before and after 1 month of intervention
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.
Before and after 1 month of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Audrey Bergouignan, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-1900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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