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

• ClinicalTrials.gov Identifier: NCT04664205
• Recruitment Status: Active, not recruiting
• First Posted: December 11, 2020
• Last Update Posted: February 25, 2022
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: North Carolina Diabetes Research Center
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Other: High Intensity Interval Exercise; Other: Moderate Intensity Continuous Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: High intensity interval training, then Moderate Intensity Continuous Training; Participants randomly assigned to this arm will first receive high intensity interval training followed by moderate intensity continuous training.	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
Experimental: Moderate Intensity Continous Training, then High Intensity Training; Participants randomly assigned to this arm will first receive moderate intensity continuous training followed by high intensity interval training.	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
No Intervention: Control: No exercise; Participants will complete the same pre- post measurements, with no exercise in between.

Outcome Measures

Primary Outcome Measures :

1. Change in Carbohydrate Metabolism [ Time Frame: Baseline and 1 hour post exercise ]
   Tricarboxylic acid intermediates (concentration)
2. Change in Fat Metabolism [ Time Frame: Baseline and 1 hour post ]
   Acylcarnitine concentration

Secondary Outcome Measures :

1. Change in Continuous Glucose (Area Under the Curve) [ Time Frame: Baseline and 48 hours post exercise ]
   Continuous glucose monitoring

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 51 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

Applied Physiology Laboratory

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

North Carolina Diabetes Research Center

Investigators

• Principal Investigator: Abbie Smith-Ryan, PhD; University of North Carolina

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04664205
• Other Study ID Numbers: 20-3100
• First Posted: December 11, 2020
• Last Update Posted: February 25, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: Beginning 1 year and ending 2 years following article publication
• Access Criteria: IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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