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临床试验/NCT04664205
NCT04664205已完成不适用

Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Mean Energy Expenditure Between HIIT and MICT

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Mean Energy Expenditure Between HIIT and MICT

时间窗: During exercise

Energy expenditure measured via indirect calorimetry (kcals) during exercise.

Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism

时间窗: Baseline, 1 hour post exercise

Lactate measured using capillary finger prick (mmol/L).

次要结局

  • Change in Continuous Glucose After Exercise Into Overnight(Immediately post-exercise and Overnight)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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