The Impact of Macronutrient Composition on Glucose Dynamics in Everyday Life and During Fasted Cycling in Persons With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The primary endpoint is the difference between study arms in difference from start to end plasma glucose concentration during 45 min fasted cycling (assessed by YSI (Yellow Spring Instruments 2900 STAT Plus)).
研究概览
简要总结
A randomized, open-label, three-arm crossover study will be conducted. The aim of the study is to determine the effect of different isocaloric diet macronutrient compositions (High-carbohydrate-Low-fat-Low-protein (HCLFLP), Low-carbohydrate-High-fat-Low-protein (LCHFLP), Low-carbohydrate-Low-fat-High-protein (LCLFHP)) on plasma glucose dynamics in everyday life and during fasted exercise in persons with type 1 diabetes. Our hypothesis is that a HCLFLP diet reduce the decrease in plasma glucose from start to end of fasted exercise compared with a LCHFLP diet. Secondary a LCHFLP compared with a LCLFHP diet does not reduces the decrease in plasma glucose from start to end of fasted exercise. The current study will contribute with new knowledge about the importance of the compositions of a low-carbohydrate diet on glucose dynamics and the influence on plasma glucose during and after cycling in fasted state.
详细描述
Background:
In order to increase time, spend in euglycemia ranges many persons with type 1 diabetes choose to follow a low-carbohydrate diet. However, to date strong evidence on the effects of low-carbohydrate diets in persons with type 1 diabetes is lacking with even less evidence pertaining around physical activity. Our impression is that many persons with type 1 diabetes follow a low-carbohydrate diet on their own initiative despite published available evidence is sparse. This emphasizes the need for more clinical trials that investigates the glycemic impact of low-carbohydrate diets.
The current guidelines for glucose management during exercise focus on carbohydrate intake and reduction of bolus and/or basal insulin immediately before, during and after exercise. The guidelines only briefly describe low-carbohydrate diet and do not describe matters concerning exercise in fasted state, because of lack of evidence in the field. Exercise in fasted state may be preferable for persons with type 1 diabetes since it increases lipid oxidation and is associated with better glucose stability than nonfasted exercise. Furthermore exercise in fasted state do not increase the risk of hypo- or hyperglycemia compared with a non-exercise control day.
Dietary carbohydrate intake might affect the hepatic glucose response. We will use glucagon as a tool to evaluate the hepatic glucose response after the three different diets.
The current study will contribute new knowledge about the importance of the compositions of a low-carbohydrate diet on glucose dynamics and the influence on plasma glucose during and after cycling in fasted state. In addition, the study will detail the importance of diet carbohydrate content on hepatic glucose response.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Type 1 diabetes ≥ 5 years
- •Insulin pump use ≥ 1 year
- •Use of intermittently scanned continuous glucose monitoring (isCGM) or continuous glucose monitoring (CGM) ≥ 3 months
- •HbA1c ≤ 69 mmol/mol (8.5%)
- •Self-reported hypoglycemia awareness
- •Exercising at least 30 minutes at moderate or vigorous intensity two times per week.
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 a hybrid closed-loop system
- •Females who are pregnant, breast-feeding or intend to become pregnant during the study period
- •Ischemic 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 primary endpoint is the difference between study arms in difference from start to end plasma glucose concentration during 45 min fasted cycling (assessed by YSI (Yellow Spring Instruments 2900 STAT Plus)).
时间窗: 45 min
次要结局
- Time spent < 3.0 mmol/l assessed by CGM during diet interventions(7 days)
- Plasma glucose coefficient of variation assessed by CGM during diet interventions(7 days)
- Number of hypoglycemia events (< 3.9 mmol/l) of at least 15 minutes duration assessed by CGM during diet interventions(7 days)
- Energy expenditure after each diet intervention assessed by indirect calorimetry(15 min)
- Mean CGM glucose level assessed by CGM during diet interventions(7 days)
- Mean insulin during cycling and observation phase 2(135 min)
- Carbohydrate oxidation rate assessed by indirect calorimetry during cycling and observation phase 2(135 min)
- Time spent < 3.9 mmol/l assessed by CGM during diet interventions(7 days)
- Time spent 3.9-10.0 mmol/l assessed by CGM during diet interventions(7 days)
- Fat oxidation rate assessed by indirect calorimetry during cycling and observation phase 2(135 min)
- Time to plasma glucose peak assessed by YSI during observation phase 3(120 min)
- Time from glucagon administration to 1.1 mmol/l increase in plasma glucose assessed by YSI during observation phase 3(120 min)
- Change in plasma glucose from injection of glucagon to peak plasma glucose assessed by YSI during observation phase 3(120 min)
- Time spent > 10.0 mmol/l assessed by CGM during diet interventions(7 days)
- Standard deviation assessed by CGM during diet interventions(7 days)
- Carbohydrate oxidation rate after each diet intervention assessed by indirect calorimetry(15 min)
- Fat oxidation rate after each diet intervention assessed by indirect calorimetry(15 min)
- Mean plasma glucose assessed by YSI during cycling and observation phase 2(135 min)
- Plasma glucose standard deviation assessed by YSI during cycling and observation phase 2(135 min)
- Respiratory exchange ratio after each diet intervention assessed by indirect calorimetry(15 min)
- Time spent > 13.9 mmol/l assessed by CGM during diet interventions(7 days)
- Plasma glucose nadir assessed by YSI during cycling and observation phase 2(135 min)
- Number of hypoglycemia events (< 3.9 mmol/l) assessed by YSI during cycling and observation phase 2(135 min)
- Energy expenditure assessed by indirect calorimetry during cycling and observation phase 2(135 min)
- Respiratory exchange ratio assessed by indirect calorimetry during cycling and observation phase 2(135 min)
- Plasma glucose variation assessed by YSI during cycling and observation phase 2(135 min)
- Peak insulin during cycling and observation phase 2(135 min)
- Areal under the curve for insulin during cycling and observation phase 2(135 min)
- Plasma glucose peak assessed by YSI during observation phase 3(120 min)