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NCT04664205 · ClinicalTrials.gov registry record · NA

Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
14
Enrollment target

NCT04664205: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT04664205 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04664205, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
14 participants
Enrollment target

Study Summary

Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge about exercise. Unlike traditional moderate intensity continuous training (MICT) which requires extended periods of time, high intensity interval training (HIIT) requires minimal time (\~10 minutes of exercise per session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism. The extent to which these exercise strategies alter metabolomic signatures of carbohydrate, fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults with T1D. Using a randomized cross-over approach, the primary aim is to compare the metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An additional aim will be to characterize the influence of biological sex and physiological outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of these subjects. Outcomes from the present study, with existing data from our team, will lay the foundation for a larger diet and exercise lifestyle intervention that will ultimately lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.

Primary Outcome

Energy expenditure measured via indirect calorimetry (kcals) during exercise.

Interventions

  • OTHER Control
  • OTHER High Intensity Interval Exercise
  • OTHER Moderate Intensity Continuous Exercise

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2021-02-01
Est. Completion 2022-09-15
Phase NA

What the finished NCT04664205 record still lists

NCT04664205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.

NCT04664205 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04664205 about?

NCT04664205 is a clinical study titled "Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes". Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inad...

What is the current status of trial NCT04664205?

This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2021-02-01. Estimated completion is 2022-09-15.

What interventions are being tested in trial NCT04664205?

The interventions under investigation include: Control (OTHER), High Intensity Interval Exercise (OTHER), Moderate Intensity Continuous Exercise (OTHER).

Who is sponsoring clinical trial NCT04664205?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04664205's enrollment target sits among peer trials

14 1909th of 2000 higher than 90 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT04664205, the US trial registry maintained by the National Library of Medicine. NCT04664205 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.