跳至主要内容
临床试验/NCT03862521
NCT03862521已完成不适用

Safety of Low and Very Low Carbohydrate Diets in Young Children With Type 1 Diabetes

Nemours Children's Clinic1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia

研究概览

简要总结

The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.

详细描述

The purpose of the study is to evaluate the safety of short-term (6 month) low or very-low carbohydrate diets in prepubertal children 2 to <12 years old with type 1 diabetes. Participants will be randomized to either low carbohydrate diet (carbohydrate makes up 30-39% of total daily calories) or very-low carbohydrate diet (carbohydrates are 20-29% of total daily calories). The investigators will evaluate metabolic effects of these diets by measuring the counter-regulatory hormone response to hypoglycemia at baseline and again at 3 months. Other outcomes include diabetes control as measured by HbA1c, growth and weight gain, lipid profiles, and body composition.

Participants will be admitted to the Clinical Research Center at baseline and 3 months. Gradual reduction in serum glucose to under 80 mg/dL will be achieved by an increase in their insulin infusion rate through their insulin pump. Plasma glucose, catecholamines (epinephrine, norepinephrine), glucagon, and serum ketones are measured at baseline and after glucose is below 80 mg/dL. All subjects will have lipid evaluation and body composition (DXA scan) at baseline and 6 months. Subjects' growth will be evaluated by comparing their height and weight z-score before and after the 6 months of diet intervention. Change in growth velocity will also be assessed. During the study, participants not already using continuous glucose monitoring will be placed on Dexcom G5 to monitor blood sugars regularly. Subjects will also be monitoring serum ketones at home regularly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Prepubertal children 2 to <12 years old (i.e., before 12th birthday)
  • •Type 1 diabetes for at least 6 months
  • •Patients must be using insulin pump therapy
  • •Not presently on low carbohydrate diet

排除标准

  • •On low or very low carbohydrate diet
  • •History of endocrine or metabolic disorder that could affect counter-regulation (well-controlled hypothyroidism is acceptable if on stable dose of l-thyroxine for ≥3 months)
  • •History of metabolic disorder affection lipid metabolism
  • •Severe hypoglycemic event in past 3 months

研究组 & 干预措施

Low carbohydrate diet group

Experimental

Low carb diet, carbohydrates make up 30-40% of total daily calories.

干预措施: Low carbohydrate diet (Other)

Very low carbohydrate diet

Experimental

Very low carb diet, carbohydrates make up 20-29% of total daily calories.

干预措施: Very low carbohydrate diet (Other)

结局指标

主要结局

Change in hormone (epinephrine, norepinephrine, glucagon) response to hypoglycemia

时间窗: Baseline to 3 months

Change from baseline to 3 months in the hormone (epinephrine, norepinephrine, glucagon) response to insulin-induced hypoglycemia.

次要结局

  • Change in height in centimeters from baseline to 6 months(Baseline to 6 months)
  • Change in lipid profile from baseline to 6 months(Baseline to 6 months)
  • Change in weight in kilograms from baseline to 6 months(Baseline to 6 months)
  • Change in body composition from baseline to 6 months(Baseline to 6 months)
  • Change in A1c from baseline to 3 and 6 months(Change from baseline to 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验