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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 PreDiabetes, sponsored by University of Colorado, Denver.

Recruiting
Registry status
Early Phase 1
Development phase
66
Enrollment target
1
Study location

NCT05041491: Recruiting Early Phase 1 study of PreDiabetes, sponsored by University of Colorado, Denver.

NCT05041491 is a Early Phase 1 study of PreDiabetes that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 66 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05041491, a Early Phase 1 study of PreDiabetes, 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.

Primary Outcome

Plasma glucose concentration in mg/dL measured before and 30, 60, 90 and 120 min after an oral glucose tolerance test (OGTT, 75g glucose).

Conditions Studied

Interventions

  • BEHAVIORAL BREAK
  • BEHAVIORAL ONE

Study Locations (1)

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2021-11-30
Est. Completion 2026-11-30
Phase Early Phase 1
University of Colorado, Denver

1,283 total trials

What NCT05041491 shows while recruiting

NCT05041491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (91% lower).

The record links to 1 condition, with PreDiabetes appearing as the primary indexed condition, and to 2 interventions - of which BREAK is the first listed.

NCT05041491 reports a single indexed study location in 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: PreDiabetes.

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.

Similar trials for PreDiabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05041491's enrollment target sits among peer trials

66 84th of 149 higher than 65 of 149 other PreDiabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05041491, the US trial registry maintained by the National Library of Medicine. NCT05041491 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.