Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide (FOS) Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Continuous Glucose Measuring Device Measurements
研究概览
简要总结
Diabetes is a chronic metabolic disease in which nutrients such as carbohydrates, fats and proteins cannot be utilized sufficiently due to the inability to produce insulin or defects in the effect of the produced insulin. The risk of individuals encountering complications related to diabetes decreases when glycemic control is achieved in these patients. Therefore, nutrition is an necessary component of treatment. Although there are many studies in the literature examining the effect of carbohydrate intake on glycemic control in individuals with diabetes and monitoring carbohydrate intake in individuals with diabetes is the basic strategy for reaching glucose targets, a common denominator has not yet been reached for the optimal amount of carbohydrate intake for individuals with diabetes. There are a wide range of definitions regarding carbohydrate intake and studies on carbohydrate restriction, especially in individuals with Type 1 diabetes, are limited.
In present randomized controlled crossover study, three isocaloric different dietary treatment are planned to applied for 2 weeks in which (i) 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carbohydrates according to the individual characteristics of the patients, (ii) 50-55% of the daily energy requirement is provided from carbohydrates and (iii) carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supplementing 2 sachets (1 sachet 3.68 g inulin + 3.68 g ) where 50-55% of daily energy requirement is provided from carbohydrates together with fructooligosaccharide (FOS)) inulin fructooligosaccharide (FOS) supplementation. A 2-week washout period is planned between each diet model. The research will be conducted with 20 individuals with Type 1 diabetes using a Continuous Glucose Monitoring device. The proposed project aims to investigate the effect of different dietary treatments on glycemic control in individuals with Type 1 diabetes by using a continuous glucose measuring device. At the end of each dietary treatment application, the data obtained from the Continuous Glucose Measuring Device will be evaluated as the primary outcomes; total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose will be evaluated as the secondary outcomes. As a result of the research, the potential effects of different dietary treatments on glycemic control will be evaluated and the development of the most appropriate diet model for these patients will be contributed. In addition, this research will contribute to the improvement of the continuous glucose monitoring device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
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
- •Patients aged 18-65 years diagnosed with Type 1 diabetes and currently using a Continuous Glucose Monitoring device
排除标准
- •Individuals with type 2 diabetes
- •Individuals with gestational diabetes
- •Breastfeeding individuals
- •Individuals with celiac disease
- •Individuals with gastroparesis
- •Renal insufficiency (tGFR ≤ 60 ml/min/1.73 m2)
- •Diagnosed liver failure
- •Immunodeficiency
- •Individuals with malignancy
- •Using nutritional supplements that may affect metabolic parameters
研究组 & 干预措施
50-55% of the daily energy requirement is provided from carbohydrates
干预措施: Dietary carbohydrate 50-55% (Other)
carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp
干预措施: fructooligosaccharide and inulin (Dietary Supplement)
30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carb
干预措施: Dietary carbohydrate 30% (Other)
结局指标
主要结局
Continuous Glucose Measuring Device Measurements
时间窗: From the enrollment to the end of treatment at 8 weeks
次要结局
- Other measurements(From the enrollment to the end of the treatment at 12 weeks)
研究者
Mevlude Kizil
Professor
Hacettepe University
