Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Episodes of diabetes related visits to the hospital, DKA
研究概览
简要总结
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.
详细描述
The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.
During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
- •No carbohydrate restrictions at the time of recruitment.
- •No medications that could affect appetite
- •Regular attendance at the clinic (3-4 times per year),
- •Glycated hemoglobin (HbA1c) <10%.
排除标准
- •Impaired renal or liver function,
- •Chronic seizures or global developmental delay,
- •Diagnosed with ADHD and/or on ADHD medications
- •Use of drugs other than insulin affecting glucose metabolism
- •Severe eczema
- •Celiac disease
结局指标
主要结局
Episodes of diabetes related visits to the hospital, DKA
时间窗: 6 month study period
Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.
Dyslipidemia
时间窗: 6 month study period
Investigators will evaluate the changes in LDL levels among the study groups.
Number of hypoglycemic events
时间窗: 6 month study period
Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values \<70 mg/dL but ≥ 54 mg/dL and those \<54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values \<70 mg/dL but ≥ 54 mg/dL and \<54 mg/dL).
次要结局
- Glycemic control(6 month duration of the study)
- Glucose variability(6 month study period)