Galactose - the Ideal Carbohydrate Supplement for Exercise in Type 1 Diabetes
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
- Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio.
研究概览
简要总结
In this study, 14 subjects with type 1 diabetes are studied in a randomized crossover study in which the subjects cycle at a fixed intensity at 60% of their maximum oxygen capacity (VO2 max) for 1 hour. Thirty minutes before each cycling test, participants consume a 200 ml beverage, consisting of either: 1) dextrose (20 g), 2) galactose (20 g), 3) lactose (20 g) or 4) water (sweetened). If blood sugar drops below 3.9 mmol/l, glucose infusion is given and blood sugar is kept just above 5 mmol/L.
The trial days take place at least 4 days apart.
详细描述
On study days, a catheter is placed in two antecubital veins for regular blood sampling and for glucose infusion (if needed). The participant will rest in a bed, when not performing the 1-hour bicycle ergometer test.
Thirty minutes before the leg-cycle ergometer test, the participants consume a 300 ml beverage containing either: 1) dextrose (20 g), 2) galactose (20 g) 3) lactose (20 g) or 4) water (sweetened). At t=0, the ergometer test is started and continued for 1 hour (fixed intensity cycling at 60% of VO2-max). If blood glucose drops below 3.9 mmol/l, glucose infusion (5 % glucose) will be administered, and blood glucose is kept just above 5 mmol/l and infused volume is registered.
Blood samples are collected at t= -40, 0, 30, 60, 90, 120 for measurement of plasma lactate, non-esterified fatty acids (NEFA), plasma triglyceride and hormonal concentrations (epinephrine, norepinephrine, cortisol, and glucagon). Plasma blood glucose measurements are performed at t = -40 and every 10-15 minutes until the end of the study day.
Respiratory exchange ratio is measured by indirect calorimetry (collection of respiratory gasses VO2 and VCO2) pre-exercise, at the end of the exercise bout, and 30 minutes post-exercise. Protein oxidation rate is estimated from urinary urea excretion, and net lipid and glucose oxidation rates are calculated from indirect calorimetry measurements with correction for protein oxidation. Therefor a urine sample will also be collected at the end of the study day.
The bicycle ergometer test is discontinued after 1 hour of bicycling and the participant is observed until 2 hour post exercise where the study day is ended.
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
- Single (Participant)
盲法说明
The participants will receive either dextrose, water, lactose, galactose in a randomized order (computer generated block randomization) prior to a one-hour exercise bout. Participants, but not investigators, are masked to nutrition allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes for at least 2 years
- •age between 18 and 65 years
- •HbA1c less than 70 mmol/mol
- •Physically active (at least 150 minutes of moderate-to-vigorous intensity activity weekly)
- •Insulin pen and pump treatment
- •Men and women are eligible, but women will have to perform study days in the mid-cycle phase of the menstrual cycle.
排除标准
- •- Diabetic nephropathy, neuropathy, and proliferative retinopathy
- •Hypoglycemia unawareness
- •Lactose intolerance
- •Heart disease and other conditions which may be negatively affected by the VO2 max test and 1-hour cycling on study days
研究组 & 干预措施
Dextrose
30 g in 200 ml liquid
干预措施: 1-hour cycling (Other)
Water
200 ml liquid sweetened
干预措施: 1-hour cycling (Other)
Galactose
30 g in 200 ml liquid
干预措施: 1-hour cycling (Other)
Lactose
30 g in 200 ml liquid
干预措施: 1-hour cycling (Other)
结局指标
主要结局
Time to hypoglycemia Secondary endpoints: Blood glucose variability, volume of intravenous glucose needed to maintain glucose above 5 mmol/l, respiratory exchange ratio.
时间窗: during and 2 hours after the bicycle test
time to blood glucose \< 3.9 mmol/l
次要结局
- Glucose infusion(during and 2 hours after the bicycle test)
- Time in Range(prior, during and 2 hours after the bicycle test)
- Blood glucose variability(during and 2 hours after the bicycle test)
- Respiratory exchange ratio(prior, during and 2 hours after the bicycle test)
研究者
Rakel Johansen
Principal investigator, MD, Ph.D.
University of Aarhus