Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T1DM for at least 12 months
- •Age 13 to 21 years
- •Total daily dose of insulin 0.5 to 1.25 units/kg/day
- •Current use of an insulin pump and CGM
- •HbA1c between 7% and 10%
- •Tanner stage 3 to 5 on physical exam
- •Participant or parent of participant use of smart phone
- •Able to read and speak English
排除标准
- •Any episode of diabetic ketoacidosis (DKA) in the last 12 months
- •Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months
- •Any prior abnormal fasting lipid panel (LDL > 130)
- •Additional dietary restrictions
- •Following a weight-loss or otherwise restrictive diet
- •Use of medication or supplements other than insulin to control blood glucose
- •Use of medication or other supplements to lower lipids
- •Pregnancy or breast feeding
- •History of hemoglobinopathy
结局指标
主要结局
Change in HbA1c
时间窗: Baseline to week 12
HbA1c (%) change will be measured from baseline to 12 weeks
次要结局
- Percent of Time Spent Below the Glycemic Target of 70 mg/dL(Baseline to Week 12)
- Change in Average Blood Glucose(Baseline to 12 weeks)
- Percent of Time Spent Above the Glycemic Target of 140 mg/dL(Baseline to Week 12)
- Percent of Time Spent in Hypoglycemia Below 50 mg/dL(Baseline to Week 12)
- Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL(Baseline to Week 12)
- Change in the Blood Glucose Standard Deviation(Baseline to 12 weeks)
- Change in Average Total Daily Dose of Insulin(Baseline to 12 weeks)
- Change in Average Bolus Amount of Insulin Per Day(Baseline to 12 weeks)
- Change in Average Basal Amount of Insulin Per Day(Baseline to 12 weeks)
- Change in Low Density Lipoprotein Particle Number(Baseline to 12 weeks)
- Change in High Density Lipoprotein Particle Number(Baseline to 12 weeks)
- Change in Small Low Density Lipoprotein Particle Number(Baseline to 12 weeks)
- Change in Low Density Lipoprotein Size(Baseline to 12 weeks)
- Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)(Baseline to 12 weeks)
- Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module(Baseline to week 12)
- Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report(Baseline to week 12)
研究者
Sara Duffus
Clinical Fellow, Division of Pediatric Endocrinology
Vanderbilt University Medical Center