- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664205
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes (HI1T)
December 2, 2022 updated by: University of North Carolina, Chapel Hill
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Applied Physiology Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 51 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
One session of high intensity interval exercise
One session of calorically matched moderate intensity exercise
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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.
|
One session of high intensity interval exercise
One session of calorically matched moderate intensity exercise
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No Intervention: Control: No exercise
Participants will complete the same pre- post measurements, with no exercise in between.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Carbohydrate Metabolism
Time Frame: Baseline and 1 hour post exercise
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Tricarboxylic acid intermediates (concentration)
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Baseline and 1 hour post exercise
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Change in Fat Metabolism
Time Frame: Baseline and 1 hour post
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Acylcarnitine concentration
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Baseline and 1 hour post
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Continuous Glucose (Area Under the Curve)
Time Frame: Baseline and 48 hours post exercise
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Continuous glucose monitoring
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Baseline and 48 hours post exercise
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Abbie Smith-Ryan, PhD, University of North Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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