Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes (HI1T)

Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: High Intensity Interval Exercise; Other: Moderate Intensity Continuous Exercise; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Applied Physiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: High Intensity Interval Exercise; One session of high intensity interval exercise; Other: Moderate Intensity Continuous Exercise; One session of calorically matched moderate intensity exercise; Other: Control; No exercise, resting measures
Experimental: 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.	Other: High Intensity Interval Exercise; One session of high intensity interval exercise; Other: Moderate Intensity Continuous Exercise; One session of calorically matched moderate intensity exercise; Other: Control; No exercise, resting measures
Experimental: 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.	Other: High Intensity Interval Exercise; One session of high intensity interval exercise; Other: Moderate Intensity Continuous Exercise; One session of calorically matched moderate intensity exercise; Other: Control; No exercise, resting measures

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Continuous Glucose After Exercise Into Overnight	Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.	Immediately post-exercise and Overnight

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Diabetes Research Center
• Investigators: Principal Investigator: Abbie Smith-Ryan, PhD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 20-3100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: Beginning 1 year and ending 2 years following article publication
• IPD Sharing Access Criteria: IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No