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Breaking Up Sedentary Time for Pre-diabetes

This study is looking at how different physical activity (PA) routines can help improve blood sugar control in people with pre-diabetes. Researchers are comparing two behavioral interventions: BREAK and ONE, both of which are physical activity regimens. The goal is to see if frequently interrupting sedentary (sitting) time with short bursts of activity can improve blood sugar levels (glycemia) more effectively than a single, longer period of exercise. You may be able to join if you are between 18 and 64 years old, have a BMI between 18.5-40 kg/m2, and have been diagnosed with pre-diabetes based on your fasting glucose, HbA1c, or 2-hour OGTT (oral glucose tolerance test) results. The study aims to enroll 66 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 66 participants to compare two different physical activity regimens.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Blood sugar levels (glycemia) will be measured at fasting, during a 2-hour OGTT, and after, but the overall follow-up duration is not specified.

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NCT05041491

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

Recruiting
EARLY_PHASE1Ages 18–64InterventionalPrevention
University of Colorado, Denver
~66 participants
Updated 2025-07-29 on ClinicalTrials.gov
What's tested:BREAKONE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycemia
Measured over Glucose concentration in mg/dl, measured at fasting, during a 2 hour OGTT and after

Conditions

Pre-diabetes

Explore related trials

Prediabetes

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Audrey Bergouignan, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Patricia Smith, MS, RDN
[email protected]
303.724.6821
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • GlycemiaGlucose 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).