Taking people in United StatesEarly phase 1

Breaking up sitting time with short walks to test blood sugar control

Tests short hourly walks versus one daily walk in adults with prediabetes.

Key facts

Who runs it: University of Colorado, Denver
Where: Aurora, United StatesSee the site
Trial code: NCT05041491
Registry title: Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
Status: Recruiting
Phase: Early phase 1
People taking part: 66 people, planned
Started: 30 Nov 2021
Expected to end: 30 Nov 2026
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: BREAK
ONE
Record updated: 29 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for inactive adults with prediabetes. It tests short walking breaks every hour against one long daily walk, to see which helps blood sugar control.

Age: 18 to 64 years old.
Sex: Men and women can join.
Disease stage: Prediabetes, shown by fasting glucose of 100-125 mg/dL (5.6–6.9 mmol/L), HbA1c of 5.7-6.4% (39–46 mmol/mol), or a 2h OGTT glucose of 140-199 mg/dL (7.8–11 mmol/L).
Earlier treatment: Metformin taken steadily for 1 year to prevent diabetes is accepted. No medicines that affect weight, triglycerides, energy use or sleep in the last 3 months.
Biomarker or test result: Fasting glucose, HbA1c or OGTT result in the prediabetes range. BMI 18.5-40 kg/m2 with stable weight over the last 6 months.

Main reasons for not taking part

Pregnant, breast-feeding or post-menopausal women
History of diabetes, heart disease, uncontrolled high blood pressure, or thyroid, kidney or liver disease
Positive for HIV, hepatitis B or hepatitis C
Smoker, or smoked in the last 3 months
Does 150 minutes or more of moderate-to-vigorous activity per week, or walks 6500 or more steps per day

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

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

Who cannot take part

Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months
Being a smoker or having been a smoker in the 3 months prior to their screening visit
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
Pregnancy, breast-feeding or post-menopause for women
Being considered unsafe to participate as determined by the study physician
Having abnormal blood chemistry and/or hematology as deemed significant by the study physician
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 64 years old?

Where in United States

University of Colorado Anschutz Medical CampusAurora, United StatesContact: Audrey Bergouignan, PhD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

BREAK InterventionTreatment being tested
Participants in the BREAK condition will perform 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week for 3 months.
Treatment: BREAK
ONE InterventionExisting treatment, for comparison
Participants in the ONE condition will perform 45 minutes of brisk walking as a single continuous bout, 5 days/week for 3 months.
Treatment: ONE