Slow-digestible Carbohydrates Consumed Prior to Exercise Improve Performance and Decrease Risk of Delayed Hypoglycemia in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glycemic variability during exercise challenge
研究概览
简要总结
In this within-subject cross-over study, the investigators hypothesize that corn-starch based supplements taken prior to exercise will decrease the risk of delayed hypoglycemia in adolescents with T1D, improve performance during exercise, and decrease glycemic variability during exercise.
详细描述
Type 1 diabetes (T1D), one of the most common chronic diseases in adolescents, is caused by the destruction of insulin producing beta cells which are located in the pancreas. There are many factors that impact diabetes control which are insulin administration, intake of food and exercise. When an individual exercises, weight is better managed which allows for a better cardiovascular system. Exercising also improves insulin sensitivity which can increased the risk for delayed hypoglycemia (low blood sugar). Many individuals with T1D do not participate (or under-participate) in exercise due to the fear of hypoglycemia. This study will recruit adolescents with Type 1 diabetes to undergo a maximal exercise test to determine their VO2max. Study participants then will complete 2 exercise performance tests prior to which the participant will be randomized to consume 22 grams of either fast acting carbohydrates or long-acting cornstarch based supplements. Subjects will be asked to bike for 45 minutes (at 50% of VO2max) and then complete a 3.75 mile bike ride as quickly as possible. The investigators will document the time to completion of the bike ride as well as monitor glucose levels via continuous glucose monitoring for 12 hours after completion of the exercise test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 - <18 year old male and female subjects with Type 1 diabetes for > 1 year
- •HbA1c <10.5%
- •Body Mass Index >10th % and <95th%
- •Not being treated with sensor-augmented pump therapy
- •Ability to participate in exercise activity - biking
- •Willing to wear a continuous glucose monitor (CGM) sensor
排除标准
- •Severe hypoglycemia (requiring glucagon or external assistance) in last 6 months
- •Admission for diabetic ketoacidosis in last 3 months
- •History of chronic lung disease, congenital heart disease or chronic asthma
- •Food (including corn)/dye allergies
- •Other chronic medical conditions except for well-controlled thyroid disease
研究组 & 干预措施
Fast Acting Carbohydrate
Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement
干预措施: maltodextrin (Dietary Supplement)
Slow-acting cornstarch supplement
Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)
干预措施: super starch (Dietary Supplement)
结局指标
主要结局
Glycemic variability during exercise challenge
时间窗: During exercise challenge
Review of continuous glucose monitoring data
Time to completion of distance bike challenge
时间窗: During exercise challenge
Number of minutes to complete 3.75 mile bike ride
Number of hypoglycemic events 12 hours after completion of exercise challenge
时间窗: 12 hours after exercise challenge
Review of continuous glucose monitoring data
次要结局
- Percent time spent in hypoglycemia following exercise challenge(12 hours after exercise challenge)
- Percent time above range, in range, and below range following exercise challenge(12 hours after exercise challenge)
- Glycemic variability in the 12 hours following the exercise test(12 hours after exercise challenge)
研究者
Lucy D Mastrandrea
Professor
State University of New York at Buffalo