Actively Recruiting

Early Phase 1
Age: 18Years - 64Years
All Genders
ID05041491

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

Led by University of Colorado, Denver · Updated on 2025-07-29

66

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how breaking up long periods of sitting with short bouts of physical activity affects blood sugar control in adults at risk of developing type 2 diabetes. The study focuses on adults with prediabetes, aiming to see if interrupting sedentary time with frequent activity improves glucose levels more than a single continuous exercise session. This research addresses gaps about the lasting effects and underlying mechanisms of such activity patterns in this population. Participants will be randomly assigned to one of two groups for a 3-month period. One group (BREAK) will do 5-minute brisk walking sessions every hour for 9 hours a day, 5 days a week. The other group (ONE) will perform a single 45-minute brisk walk daily, 5 days a week. Both interventions match the total active time but differ in how activity is spread across the day. During the study, participants will wear activity monitors and follow controlled diets before certain clinic visits. Researchers will measure blood glucose levels using fasting tests and 2-hour oral glucose tolerance tests, along with other metabolic markers and muscle protein content. Outcomes will be assessed before, during, and after the intervention periods, with monitoring of exercise adherence, safety, and other health parameters throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 140-199 mg/dL within 3 months prior to screening
  • Use of Metformin for 1 year to prevent diabetes is allowed
  • Less than 150 minutes of moderate-to-vigorous physical activity per week
  • More than 6 hours of sitting time per day
  • Less than 6500 steps per day measured by pedometer over 5 days
  • Passing medical and physical screening and blood and urine tests
  • Low to moderate caffeine intake (less than 3 cups/day)
  • Agree to avoid other structured exercise during the study
  • Agree to follow control diets before and during clinic visits
  • Agree to refrain from certain medications before clinic visits
  • Agree to wear a Fitbit activity monitor and upload data daily
  • Agree to follow the assigned physical activity program
  • Agree to complete all study procedures
Not Eligible

You will not qualify if you...

  • Pregnancy, breastfeeding, or post-menopause for women
  • Considered unsafe to participate by study physician
  • 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 conditions affecting weight or lipid metabolism
  • Positive for HIV or hepatitis B or C
  • Taking medications affecting weight, triglycerides, energy, or sleep in past 3 months
  • Abnormal blood chemistry or hematology as judged by physician
  • Current smoker or smoked within 3 months prior to screening
  • Donated more than 400 mL of blood within 3 months prior to screening
  • Working night shifts within 1 month prior and during the study
  • Failure to complete screening period trial days for interventions

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for medical, physical, blood, and urine tests

Outpatient Treatment

Duration - 3 months

Participants follow a physical activity regimen to improve glucose control. One group performs 5-minute bouts of brisk walking hourly for 9 hours/day, 5 days/week. The other group performs 45 minutes of continuous brisk walking 5 days/week. The intervention lasts for 3 months.

Regular monitoring visits during the 3-month intervention period

Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

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Research Team

P

Patricia Smith, MS, RDN

A

Audrey Bergouignan, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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