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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: High Intensity Interval Exercise; Other: Moderate Intensity Continuous Exercise; Other: Control

• Registration Number: NCT04664205
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-11
• Study Start: 2021-02-01
• Status Verified: 2022-02
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Results First Submitted: 2024-02-08
• Results First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Results First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moderate Intensity Continuous Training, High Intensity Training, Control	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.
High intensity interval training, Moderate Intensity Continuous Training, Control	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.
Moderate Intensity Continuous Training, High Intensity Training, Control	High Intensity Interval Exercise	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.
Moderate Intensity Continuous Training, High Intensity Training, Control	Moderate Intensity Continuous Exercise	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.
Control session, High intensity interval training, moderate intensity continuous training	Moderate Intensity Continuous Exercise	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.
High intensity interval training, Moderate Intensity Continuous Training, Control	High Intensity Interval Exercise	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.
High intensity interval training, Moderate Intensity Continuous Training, Control	Moderate Intensity Continuous Exercise	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.
Control session, High intensity interval training, moderate intensity continuous training	High Intensity Interval Exercise	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.
Control session, High intensity interval training, moderate intensity continuous training	Control	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.

Primary Outcome Measures

Name	Time	Method
Mean Energy Expenditure Between HIIT and MICT	During exercise	Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism	Baseline, 1 hour post exercise	Lactate measured using capillary finger prick (mmol/L).

Secondary Outcome Measures

Name	Time	Method
Change in Continuous Glucose After Exercise Into Overnight	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.

Trial Locations

Locations (1)

Applied Physiology Laboratory; 🇺🇸 Chapel Hill, North Carolina, United States