The Effect of a Low-carbohydrate-high-protein Pre-exercise Meal on Exercise-induced Hypoglycemia in People With 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
- The area over the curve (AOC).
研究概览
简要总结
This study is a clinical, randomized, crossover study. The study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content. The study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia.
详细描述
Background:
People with type 1 diabetes practicing a low-carbohydrate diet can increase the fat and/or protein content of the diet to cover their energy needs. In relation to physical activity, ingestion of protein is preferable for muscle protein synthesis and enhances structural changes in non-muscle tissues such as tendons and bones. Furthermore, addition of ≥ 28 g of protein to a meal is likely to result in significant and sustained postprandial hyperglycemia commencing in the late postprandial period (2-3 h) and continuing beyond 5 h in people with type 1 diabetes. The protein-induced change in the postprandial glucose response could be beneficial in relation to prevention of exercise-induced hypoglycemia. Hypoglycemia is a common fear in people with type 1 diabetes and makes many abstain from exercising.
This study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content.
This study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia. The study may add new aspects to current guidelines for glucose management during exercise in people with type 1 diabetes. If the strategy has a positive effect on preventing exercise-induced hypoglycemia it will be useful to all people with type 1 diabetes irrespective of diet strategy.
Study design:
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years.
- •Type 1 diabetes ≥ 5 years.
- •Insulin pump use ≥ 1 year.
- •Use of flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) ≥ 3 months.
- •Body mass index 18.5-30 kg/m
- •HbA1c ≤ 64 mmol/mol (8.0%).
- •Self-reported hypoglycemia awareness
- •Ability to carbohydrate count for all meals.
- •Familiarity with the insulin pump bolus calculator for all meals.
- •Moderate to vigorous level of physical activity
排除标准
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
- •Use of Metronic Minimed 670G insulin pump system.
- •Allergy to paracetamol or nuts
- •Females who are pregnant, breast-feeding or intend to become pregnant.
- •Heart disease.
- •Severe asthma.
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation.
结局指标
主要结局
The area over the curve (AOC).
时间窗: 7 hours.
The primary outcome measure is the AOC for plasma glucose (PG) \< 3.9 mmol/L during the in-clinic period assessed by YSI (Yellow Spring Instruments 2900 STAT Plus). The AOC is the area, which extends from the plasma glucose curve to the limit for hypoglycemia \< 3.9 mmol/l.
次要结局
- Satiety (assessed by visual analog scale after pre-exercise meal) during the in-clinic period(7 hours.)
- Time spent < 3.0 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Time spent 3.0-3.8 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Time spent 3.9-10.0 mmol/l during in-clinic period, home period and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Time spent < 3.9 mmol/l during in-clinic period assessed by YSI.(7 hours.)
- Time spent > 10.0 mmol/l during in-clinic period, home period and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Glycemic variability (% coefficient of variation) during in-clinic period assessed by YSI.(7 hours.)
- Area under the curve of total insulin during in-clinic period(7 hours)
- Area under the curve of ketones during the in-clinic period.(7 hours)
- Area under the curve of TNFα during the in-clinic period(7 hours)
- Physical performance during the exercise phase evaluated by watt(45 minutes)
- Time spent < 3.9 mmol/l during in-clinic period, home period and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Time spent 3.0-3.8 mmol/l during in-clinic period assessed by YSI.(7 hours.)
- Time spent < 3.0 mmol/l during in-clinic period assessed by YSI.(7 hours.)
- Time spent > 13.9 during in-clinic period, home period and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Number of hypoglycemia events (< 3.9 mmol/l) in-clinic period, home period and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM.(3 hours)
- Area under the curve of cortisol during the in-clinic period.(7 hours)
- Area under the curve of norepinephrine during the in-clinic period.(7 hours)
- Area under the curve of free fatty acids during the in-clinic period.(7 hours)
- Area under the curve of GLP-1 during the in-clinic period(7 hours)
- Area under the curve of IL6 during the in-clinic period(7 hours)
- Feeling of physical hardness during the exercise phase evaluated using the Borg Scale.(45 minutes.)
- Time spent > 10.0 during in-clinic period assessed by YSI.(7 hours.)
- Time spent > 13.9 during in-clinic period assessed by YSI.(7 hours.)
- Number of hypoglycemia events (< 3.9 mmol/l) during in-clinic period assessed by YSI.(7 hours.)
- Area under the curve of glucagon during the in-clinic period.(7 hours)
- Area under the curve of growth hormone during the in-clinic period.(7 hours)
- Area under the curve of lactate during the in-clinic period.(7 hours)
- Area under the curve of GIP during the in-clinic period(7 hours)
- Area under the curve of IL-1ra during the in-clinic period(7 hours)
- Area under the curve of IL-1β during the in-clinic period(7 hours)
- Respiratory exchange ratio (RER) during the in-clinic period(7 hours)
- Physical performance during the exercise phase evaluated by heart rate(45 minutes)
- Glycemic variability (% coefficient of variation) during in-clinic, home, and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Standard deviation (SD) during in-clinic period, home period, and overall study period assessed by CGM.(7, 17 and 24 hours respectively.)
- Standard deviation (SD) during in-clinic period assessed by YSI.(7 hours.)
- Amount of dextrose in grams ingested to treat hypoglycemia (< 3.9 mmol/l) during in-clinic period, home period and overall study period.(7, 17 and 24 hours respectively.)
- Area under the curve of epinephrine during the in-clinic period.(7 hours)
- Energy expenditure during the in-clinic period (kcal/min)(7 hours)
- Time of gastric emptying after ingestion of the pre-exercise meal assessed by serum paracetamol.(7 hours.)
- Time-to-peak PG/blood glucose after ingestion of pre-exercise meal assessed by YSI and CGM(3 hours)
- Area under the curve of IL-10 during the in-clinic period(7 hours)
- Carbohydrate and fat oxidation rates during the in-clinic period(7 hours.)