RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-30
Study Completion:2025-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05041491

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female
  2. * BMI of 18.5-40 kg/m2and weight stable over the previous 6 months.
  3. * Age, 18-64 years old.
  4. * 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 (ADA) criteria for pre-diabetes.
  5. * 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).
  6. * Less than 6500 of steps per day as measured by a pedometer over 5 days (at least 1 weekend day).
  7. * Passing medical and physical screening, and analysis of blood and urine screening samples.
  8. * Low-moderate caffeine use (\<3 cups/day).
  9. * Agree to refrain from any other structured exercise than the physical activity prescribed in each arm of the study.
  10. * Agree to eat control diets for 3 days before and during the Clinical and Translational Research Center (CTRC) visits;
  11. * 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;
  12. * Agree to wear a Fitbit® activity monitor and upload data on the website on a daily basis for the whole duration of the study.
  13. * Agree to follow the physical activity interventions and to be randomly assigned to one of the two arms of the study.
  14. * Agree to complete all the study procedures.
  1. * Pregnancy, breast-feeding or post-menopause for women.
  2. * Being considered unsafe to participate as determined by the study physician.
  3. * Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
  4. * History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism.
  5. * Being positive for human immunodeficiency virus or hepatitis B or C.
  6. * Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months.
  7. * Having abnormal blood chemistry and/or hematology as deemed significant by the study physician.
  8. * Being a smoker or having been a smoker in the 3 months prior to their screening visit.
  9. * Having donated over 400 mL of blood within 3 months (90 days) of screening for the study;
  10. * Working night shifts or traveling across more than 2 time zones within 1 month of and throughout the study.
  11. * 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.

Contacts and Locations

Study Contact

Patricia Smith, MS, RDN
CONTACT
303.724.6821
trish.smith@cuanschutz.edu
Audrey Bergouignan, PhD
CONTACT
303.724.9026
audrey.bergouignan@cuanschutz.edu

Principal Investigator

Audrey Bergouignan, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Audrey Bergouignan, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-11-30
Study Completion Date2025-10-15

Study Record Updates

Study Start Date2021-11-30
Study Completion Date2025-10-15

Terms related to this study

Keywords Provided by Researchers

  • sedentary behavior
  • physical activity
  • glucose control
  • metabolism
  • pre-diabetes

Additional Relevant MeSH Terms

  • Pre-diabetes