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临床试验/NCT02068638
NCT02068638已完成不适用

Exercise-related Fuel Metabolism and Glucose Stability in Individuals With Type 1 Diabetes Mellitus

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Amount of exogenous glucose required to maintain glycemia within a range between 7-10mM

研究概览

简要总结

Whereas physical activity clearly results in improvements in glycemic control in type 2 diabetes, in individuals with type 1 diabetes (T1DM) the impact of exercise on blood sugar control is more complex. In type 1 diabetes T1DM the inability to reduce exogenous insulin levels during exercise is a key factor that contributes to an increased risk of exercise-induced hypoglycemia. Since rapid adaptation of insulin dosage may be especially difficult in patients on a multiple daily injection regimen, alternative strategies are required to improve exercise-associated glucose stability. There is increasing evidence that the combination of steady state continuous low to moderate intensity exercise with short bursts of high intensity exertion (eg in the form of sprints) is an effective, well tolerated, novel strategy to prevent exercise-related hypoglycemia. A further promising option to stabilize blood sugar levels during and after exercise may be the ingestion of fructose in addition to glucose in form of a sport drink.

详细描述

Background

Regular physical activity enhances insulin sensitivity in both healthy subjects and patients with diabetes mellitus. However, while the effects of physical activity on glucose control are undoubtedly beneficial in patients with type 2 diabetes, exercise can cause major disturbances in blood glucose levels in type 1 diabetic individuals. Hypoglycemia is a common complication in patients with T1DM engaging in endurance activities such as running and cycling. So far there are limited strategies suggested to improve exercise-related blood sugar self-management. Current recommendations focus on variation in timing and dosage of insulin administration and adjustments in carbohydrate intake. Since rapid adaptation of insulin dosage may be difficult, alternative strategies to improve exercise-related glucose stability are required. Increasing evidence suggests that intermittent high intensity exercise (IHE), by triggering a counterregulatory hormone response, may counter-balance the risk of exercise-associated hypoglycemia. However, previous studies investigating IHE in T1DM were limited by heterogeneous study populations, comparably short exercise protocols, and deficits in standardization procedures. In addition, a comprehensive assessment of the underlying fuel metabolism has not been performed so far. As a consequence, the results remain controversial and their interpretation as well as applicability are restricted.

A further alternative strategy to maintain stable glycemia during exercise may be deduced from recent studies in non-diabetic individuals suggesting that the combined ingestion of fructose and glucose during exercise provides the liver with an increased amount of gluconeogenic precursors, thereby reducing consumption of endogenous glycogen stores.Moreover, conversion of fructose into glucose and lactate may provide constant and efficient fuel for working muscles. However, studies assessing the impact of fructose ingestion during exercise in patients with T1DM have not been performed so far.

Objective

The investigators aim to assess the impact of two novel non-pharmaceutical and easily feasible approaches on exercise-related blood glucose stability and its underlying exercise-related fuel metabolism in patients with T1DM.

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 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Aged 18 to 35 years
  • Diabetes mellitus duration for at least 5 years
  • No change in insulin regimen for at least 3 months prior to the study
  • Under acceptable to good metabolic control
  • Normal insulin sensitivity
  • Regular physical activity
  • BMI in the range of 18-25 kg/m2
  • Written informed consent
  • Exclusion Criteria
  • Diabetes-related complications (macro and microvascular)
  • Anemia (hemoglobin concentration <130g/l)
  • Abnormal thyroid function
  • Dyslipidemia
  • Major depression, psychosis and other severe personality disorders, claustrophobia
  • Active neoplasia
  • Contraindications to exposure to a 3 T magnetic field
  • Abnormal liver or renal function
  • Smoking, drug abuse, or daily alcohol consumption >60g
  • Participation in another study
  • Medication other than insulin

排除标准

  • 未提供

结局指标

主要结局

Amount of exogenous glucose required to maintain glycemia within a range between 7-10mM

时间窗: 30 minutes (last 30 minutes of 90 min exercise period)

次要结局

  • Glucose kinetics(180 minutes)
  • Counterregulatory hormones, metabolites, and inflammatory response(300 minutes)
  • Heart rate variability(90 minutes)
  • Exercise - related glycogen consumption(90 minutes)
  • Spiroergometric parameters(180 minutes)
  • Pre- and post-exercise glycemic excursions(72 h pre-exercise and 72 h post-exercise respectively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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