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

NCT ID: NCT04664205

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-09-15

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

High intensity interval training, Moderate Intensity Continuous Training, Control

Participants randomly assigned to this arm will first receive high intensity interval training and then randomly assigned to both moderate intensity continuous training and control session, on different days.

Group Type: EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type: OTHER

One session of high intensity interval exercise

Moderate Intensity Continuous Exercise

Intervention Type: OTHER

One session of calorically matched moderate intensity exercise

Control

Intervention Type: OTHER

No exercise, resting measures

Moderate Intensity Continuous Training, High Intensity Training, Control

Participants randomly assigned to this arm will first receive moderate intensity continuous training then randomly assigned to both high intensity interval training and a control session, on different days.

Group Type: EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type: OTHER

One session of high intensity interval exercise

Moderate Intensity Continuous Exercise

Intervention Type: OTHER

One session of calorically matched moderate intensity exercise

Control

Intervention Type: OTHER

No exercise, resting measures

Control session, High intensity interval training, moderate intensity continuous training

Participants randomly assigned to this arm will first complete a control session (no exercise) and then randomly assigned to both by a high intensity interval training and moderate intensity continuous training session, on different days.

Group Type: EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type: OTHER

One session of high intensity interval exercise

Moderate Intensity Continuous Exercise

Intervention Type: OTHER

One session of calorically matched moderate intensity exercise

Control

Intervention Type: OTHER

No exercise, resting measures

Interventions

High Intensity Interval Exercise

One session of high intensity interval exercise

Intervention Type: OTHER

Moderate Intensity Continuous Exercise

One session of calorically matched moderate intensity exercise

Intervention Type: OTHER

Control

No exercise, resting measures

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Diabetes Research Center

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbie Smith-Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Applied Physiology Laboratory

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-3100

Identifier Type: -

Identifier Source: org_study_id