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

NCT04664205 | Completed Results DMC

• 1 other identifier: 20-3100
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Continuous Glucose After Exercise Into Overnight

  Immediately post-exercise and Overnight

Study Arms (3)

High intensity interval training, Moderate Intensity Continuous Training, Control

EXPERIMENTAL

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; Other: Moderate Intensity Continuous Exercise; Other: Control

Moderate Intensity Continuous Training, High Intensity Training, Control

EXPERIMENTAL

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; Other: Moderate Intensity Continuous Exercise; Other: Control

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

EXPERIMENTAL

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; Other: Moderate Intensity Continuous Exercise; Other: Control

Interventions

High Intensity Interval Exercise OTHER

One session of high intensity interval exercise

Control session, High intensity interval training, moderate intensity continuous training; High intensity interval training, Moderate Intensity Continuous Training, Control; Moderate Intensity Continuous Training, High Intensity Training, Control

Moderate Intensity Continuous Exercise OTHER

One session of calorically matched moderate intensity exercise

Control session, High intensity interval training, moderate intensity continuous training; High intensity interval training, Moderate Intensity Continuous Training, Control; Moderate Intensity Continuous Training, High Intensity Training, Control

Control OTHER

No exercise, resting measures

Control session, High intensity interval training, moderate intensity continuous training; High intensity interval training, Moderate Intensity Continuous Training, Control; Moderate Intensity Continuous Training, High Intensity Training, Control

Eligibility Criteria

• Age: 18 Years - 51 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin
• Last hemoglobin A1c \<9%
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Diabetes Research Center: collaborator

Study Sites (1)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Abbie Smith-Ryan, PhD
• Organization: University of North Carolina at Chapel Hill

abbsmith@email.unc.edu

919-962-2574

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: February 1, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)