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临床试验/NCT07673523
NCT07673523进行中(未招募)不适用

Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide (FOS) Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月11日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Dietary carbohydrate 50-55% (Other)

carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mevlude Kizil

Professor

Hacettepe University

研究点 (1)

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