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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Early Phase 1
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Patricia Smith, MS, RDN
trish.smith@cuanschutz.edu
303.724.6821
Backup
Audrey Bergouignan, PhD
audrey.bergouignan@cuanschutz.edu
303.724.9026
Time Frame
Start Date: 2021-11-30
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 66
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov