Influence of Sucrose-free Diet or Sucrose-added Diet on Glucose Variability in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Compare the intraday and interday glucose variability effect of sucrose-free with a sucrose-free diet for patients with type 1 diabetes.
研究概览
简要总结
BACKGROUND: The treatment with continuous glucose monitoring system (CGMS) offers improved glycemic control for patients with type 1 diabetes. However, patients with type 1 diabetes usually intake foods with sugar, even without hypoglycemic episodes, and the use of advanced carbohydrate counting method may increase the calories and carbohydrate intake.
OBJECTIVE: To evaluate and compare the influence of sucrose-free diet or sucrose-added diet on glucose variability in patients with type 1 diabetes.
METHODS: The study was a simple-blind, two-way crossover design in which patients with type 1 diabetes will receive a control diet (a diet with a little quantity of sugars) or test diet (with foods containing moderate quantity of sucrose in composition) during two-days each. During the intervention, all foods and drinks intake will have to be documented to allow quantitative estimation of dietary intake, to verify adherence to the diets. After one-week, each patient will return for download CGMS.
PURPOSE: The research proposal adds knowledge about the glucose variability in patients with type 1 diabetes who use foods with sugar in theirs habitual dietary intake.
详细描述
INTRODUCTION:
The continuous glucose monitoring system (CGMS) offers improved glycemic control for patients with type 1 diabetes, because may reduce asymptomatic hypoglycemic and postprandial hyperglycemia events (1, 2).
Glycemic disorder may be estimated as a whole from the determination of glycosylated hemoglobin (HbA1c) level, which integrates both hypoglycemic and hyperglycemia episodes (3). Glycemic variability is a complex phenomenon that includes both intraday and interday variability (3, 4).
The mean amplitude of glycemic excursion (MAGE) is an index for assessing the intraday glycemic variability. The calculation of the MAGE is obtained by measuring the arithmetic mean of the differences between consecutive peaks and nadirs provided that the differences are greater than one standard deviation (SD) of the mean glucose value (5).
The continuous overall net glycemic action (CONGA) index is an indicator of within-day glucose variability. After the first n number of hours of observation, the investigators may calculate the difference between current observation and observation in the previous n hours. CONGA is defined as the SD of the recorded differences. The frequently used index CONGA1, CONGA2 and CONGA4, coincide with observations lasting 1, 2, or 4 h and they are, therefore, expressions of glucose variability within these intervals (6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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 ( ≥ three years after diagnosis)
- •Using basal-bolus regimen with multiple insulin injections with long-acting insulin analogues (glargine, detemir, or degludec) combined with a short-acting analogs (aspart, lispro or glulisina) OR Continuous subcutaneous insulin infusion
排除标准
- •Use of exogenous hormone (with the exception of insulin)
- •Use of antibiotics, anti-inflammatories or oral antidiabetics pharmacotherapy
- •Diagnosis of nephropathy (Creatinine clearance <90mL/min/1,73m2)
- •Gastroparesis symptoms
- •Celiac disease
- •Hypothyroidism or hyperthyroidism
- •Other types of diabetes family history
研究组 & 干预措施
Test diet
Diet with foods containing moderate quantity of sucrose in composition (80.22g; 30.2% of total carbohydrates of the diet).
Note: Both diets had the same calories, carbohydrates, proteins, fat, and fiber, and were prescribed according to the American Diabetes Association recommendations.
干预措施: Test Diet (Other)
Control diet
Diet with a little quantity of sugars (30.40g; 12.7% of total carbohydrates of the diet).
Note: Both diets had the same calories, carbohydrates, proteins, fat, and fiber, and were prescribed according to the American Diabetes Association recommendations.
干预措施: Control diet (Other)
结局指标
主要结局
Compare the intraday and interday glucose variability effect of sucrose-free with a sucrose-free diet for patients with type 1 diabetes.
时间窗: Through study completion, an average of 1 year
Intraday and interday glucose variability will be evaluated by the following indexes: CONGA: continuous overall net glycemic action (mmol/L); MAGE: mean amplitude of glycemic excursion (mmol/L); MODD: mean of daily diferences (mmol/L).
次要结局
- Evaluate the intraday glycemic variability effect of foods containing different macronutrients quantity, through CONGA index.(Through study completion, an average of 1 year)
- Compare the intraday glycemic variability effect of sucrose-free diet and sucrose-added diet, through MAGE index, in patients with type 1 diabetes(Through study completion, an average of 1 year)
- Compare the interday glycemic variability effect of sucrose-free diet and sucrose-added diet, through MODD index, in patients with type 1 diabetes(Through study completion, an average of 1 year)
研究者
Débora Lopes Souto
Ph.D
Universidade Federal do Rio de Janeiro