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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Exercise
Moderate Intensity Continuous Exercise
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 51 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Applied Physiology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

High intensity interval training, then Moderate Intensity Continuous Training

Moderate Intensity Continous Training, then High Intensity Training

Control: No exercise

Arm Description

Participants randomly assigned to this arm will first receive high intensity interval training followed by moderate intensity continuous training.

Participants randomly assigned to this arm will first receive moderate intensity continuous training followed by high intensity interval training.

Participants will complete the same pre- post measurements, with no exercise in between.

Outcomes

Primary Outcome Measures

Change in Carbohydrate Metabolism
Tricarboxylic acid intermediates (concentration)
Change in Fat Metabolism
Acylcarnitine concentration

Secondary Outcome Measures

Change in Continuous Glucose (Area Under the Curve)
Continuous glucose monitoring

Full Information

First Posted
December 4, 2020
Last Updated
December 2, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Diabetes Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04664205
Brief Title
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes
Acronym
HI1T
Official Title
Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Diabetes Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training, then Moderate Intensity Continuous Training
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will first receive high intensity interval training followed by moderate intensity continuous training.
Arm Title
Moderate Intensity Continous Training, then High Intensity Training
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will first receive moderate intensity continuous training followed by high intensity interval training.
Arm Title
Control: No exercise
Arm Type
No Intervention
Arm Description
Participants will complete the same pre- post measurements, with no exercise in between.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Exercise
Intervention Description
One session of high intensity interval exercise
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Continuous Exercise
Intervention Description
One session of calorically matched moderate intensity exercise
Primary Outcome Measure Information:
Title
Change in Carbohydrate Metabolism
Description
Tricarboxylic acid intermediates (concentration)
Time Frame
Baseline and 1 hour post exercise
Title
Change in Fat Metabolism
Description
Acylcarnitine concentration
Time Frame
Baseline and 1 hour post
Secondary Outcome Measure Information:
Title
Change in Continuous Glucose (Area Under the Curve)
Description
Continuous glucose monitoring
Time Frame
Baseline and 48 hours post exercise

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbie Smith-Ryan, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Physiology Laboratory
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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