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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 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants.

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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.

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 Registry Record Tells You About NCT04664205

The ClinicalTrials.gov registry entry for NCT04664205 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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

NCT04664205 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.