University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Audrey Bergouignan, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05041491
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.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Early Phase 1
Aurora, Colorado, 80045, United States
Location status: Recruiting
Audrey Bergouignan, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The BREAK intervention is a physical activity regimen.
The ONE intervention is a physical activity regimen.
Time frame: Glucose 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).
Time frame: Plasma insulin concentration in mUI/mL, measured at fasting, during a 2 hour OGTT and after
Plasma insulin concentration in milli-international units per milliliter (mUI/mL) measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).
Time frame: Before and after 1 month and 3 months of intervention
Mean interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep for 24hours for 10 days.
Time frame: Before and after 1 month and 3 months of intervention
Standard deviation (SD) of interstitial glucose concentration measured continuously by a glucose monitor placed on the tricep 24hours throughout 10 days.
Time frame: Time Frame: Before and after 1 month and 3 months of intervention
Fasting A1c concentration expressed in %
Time frame: Before and after 1 month and 3 months of intervention
Fasting fructosamine concentration in umol/L
Time frame: Before and after 1 month of intervention
Rates of carbon-13 (13C) recovery (% of the dose) in expired carbon dioxide (CO2) following the ingestion of U-13C-glucose in both breakfast and lunch meals.
Time frame: Before and after 1 month of intervention
Rates of D2 recovery (% of the dose) in expired urines following the infusion of (2,2H2) glucose.
Time frame: Before and after 1 month of intervention
CO2 production measured by indirect calorimetry (ParvoMedics TrueOne® 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.
Time frame: Before and after 1 month of intervention
O2 production measured by indirect calorimetry (ParvoMedics TrueOne 2400, Salt Lake City) for 20 minutes every hour from 0800h to 1800h.
Time frame: Before and after 1 month of intervention
Urine will be measured every hour from 0730h to 1830h
Time frame: Before and after 1 month of intervention
Steele's equation for non-steady-state will be used to compute rate of appearance of total glucose (RaT) and rate of appearance of exogenous glucose (RaE), as well as the rates of disappearance (RdT and RdE) from the percentage of [6,6-2H2]glucose6 and of 13C-glucose in plasma glucose61. Endogenous glucose production (EGP) will be computed as RaT-RaE. Nonoxidative glucose disposal (NOGD) will be calculated by subtracting total carbohydrate oxidation from (RdT + RdE). Plasma glucose utilization will be assumed to be equivalent to RdT as has been confirmed previously. Muscle glycogen utilization during the active period will be calculated as total carbohydrate utilization during exercise minus plasma glucose utilization during exercise.
Time frame: Before and after 1 month of intervention
Fasting and postprandial glucose in mg/dl measured in response to standard lunch
Time frame: Before and after 1 month of intervention
Fasting and postprandial insulin in ml/iu measured in response to standard lunch
Time frame: Before and after 1 month of intervention
Fasting and postprandial C-peptide nmol/mL measured in response to standard lunch
Time frame: Before and after 1 month of intervention
Fasting and postprandial glucagon in pg/mL measured in response to standard lunch
Time frame: Before and after 1 month of intervention
Fasting and postprandial catecholamines in pg/mL measured in response to standard lunch
Time frame: Before and after 1 month of intervention
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure protein kinase B (Akt) (Aktser473/total) using western blotting.
Time frame: Before and after 1 month of intervention
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure ACC (ACCS79/ total) using western blotting.
Time frame: Before and after 1 month of intervention
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure TBC1D4 (AS160/ total) using western blotting.
Time frame: Before and after 1 month of intervention
Vastus lateralis skeletal muscle biopsies will be collected from fasting participants by the Bergstrom technique. Biopsies will be used to measure citrate synthase (COX4) using western blotting.
Contact information is provided by the study sponsor or research team.
Audrey Bergouignan, PhD
CONTACT
Patricia Smith, MS, RDN
CONTACT
University of Colorado, Denver
Other
Acronym: BURST2D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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