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Completed

NCT Number: NCT04664205

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 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–51 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin
  • Last hemoglobin A1c <9%
  • 18-51 years
  • Duration of T1D: ≥ 1 year
  • Body mass index (BMI) <30 kg/m^2
  • Generally healthy, with no conditions that could influence the outcome of the trial, and in the judgement of the investigators is a good candidate for the study, based on a review of health history

Exclusion criteria

  • Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
  • Physician diagnosis of peripheral neuropathy with insensate feet
  • Physician diagnosis of autonomic neuropathy
  • Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin.
  • Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months
  • Diabetic ketoacidosis in the last 6 months
  • Has a closed-loop pump and not willing to use manual mode
  • Physician diagnosis of cardiovascular disease that would affect exercise tolerance
  • Currently doing HIIT
  • Severely impaired hearing or speech
  • Pregnancy

Treatment and study plan

High Intensity Interval Exercise

Other

One session of high intensity interval exercise

Moderate intensity continuous exercise

Other

One session of calorically matched moderate intensity exercise

Control

Other

No exercise, resting measures

Primary outcomes

  1. Mean Energy Expenditure Between HIIT and MICT

    Time frame: During exercise

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

  2. Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism

    Time frame: Baseline, 1 hour post exercise

    Lactate measured using capillary finger prick (mmol/L).

Secondary outcomes

  1. Change in Continuous Glucose After Exercise Into Overnight

    Time frame: Immediately post-exercise and Overnight

    Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Diabetes Research Center

Registry information

Official study title

Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes

Acronym: HI1T

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2020
Registry last updated
Jul 26, 2024

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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