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NCT05041491 · ClinicalTrials.gov registry record · Early Phase 1
Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
A Early Phase 1 study of Pre Diabetes, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT05041491 is a Early Phase 1 study of Pre Diabetes that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 66 participants, below the 728-participant average among 59 other Pre Diabetes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05041491, a Early Phase 1 study of Pre Diabetes, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL BREAK
- BEHAVIORAL ONE
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2026-11-30 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05041491
The ClinicalTrials.gov registry entry for NCT05041491 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 728-participant average among 59 other Pre Diabetes trials with a reported enrollment target (91% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pre Diabetes appearing as the primary indexed condition, and to 2 interventions - of which BREAK is the first listed.
NCT05041491 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05041491 about?
NCT05041491 is a clinical study titled "Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes". 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 decre...
What is the current status of trial NCT05041491?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 66 participants. The study started on 2021-11-30. Estimated completion is 2026-11-30.
What conditions does trial NCT05041491 study?
This clinical trial studies the following conditions: Pre Diabetes.
What interventions are being tested in trial NCT05041491?
The interventions under investigation include: BREAK (BEHAVIORAL), ONE (BEHAVIORAL).
Who is sponsoring clinical trial NCT05041491?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05041491 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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