Clinical trial NCT04664205: Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Diabetes Research Center
First posted: 2020-12-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Mean Energy Expenditure Between HIIT and MICT
timeFrame: During exercise
measure: Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism
timeFrame: Baseline, 1 hour post exercise
Secondary outcomes:
measure: Change in Continuous Glucose After Exercise Into Overnight
timeFrame: Immediately post-exercise and Overnight
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Physiology Laboratory
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: