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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04664205
Collaborator
North Carolina Diabetes Research Center (Other)
14
1
3
19
0.7

Study Details

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
  • Other: High Intensity Interval Exercise
  • Other: Moderate Intensity Continuous Exercise
N/A

Study Design

Study Type:
Interventional
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 :
Feb 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 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 [Baseline and 1 hour post exercise]

    Tricarboxylic acid intermediates (concentration)

  2. Change in Fat Metabolism [Baseline and 1 hour post]

    Acylcarnitine concentration

Secondary Outcome Measures

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

    Continuous glucose monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 51 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT04664205
Other Study ID Numbers:
  • 20-3100
First Posted:
Dec 11, 2020
Last Update Posted:
Jul 20, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022