Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Insulin Resistance Indices
研究概览
简要总结
Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.
详细描述
Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 out of 5 of the following criteria
- •Metabolic syndrome with dyslipidemia
- •(HDL <40mg/dL
- •Triglyceride (TG) TG>150mg/dL)
- •Glucose intolerance (fasting blood sugar >100mg/dL)
- •Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower)
- •Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension
排除标准
- •Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants)
- •Pregnancy
- •Untreated thyroid disease, heart disease, cancer, kidney disease
- •Children on statin/fibrate treatments or other lipid-lowering medications
- •Prior surgical procedure for weight control or current weight loss medication
结局指标
主要结局
Insulin Resistance Indices
时间窗: Baseline to 8 weeks
Percentage change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA_IR is a scale where a higher number means worse outcome
Dyslipidemia Measures
时间窗: Baseline to 8 weeks
Change in concentration of serum High density Lipoprotein in mg/dL
次要结局
- Insulin Resistance Indices(Baseline)
- Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index(Baseline to 8 weeks)
- Surrogate Markers of Vascular Endothelial Function(Baseline to 8 weeks)
- Body Composition(Baseline to 8 weeks)
研究者
Bhuvana Sunil
Principal Investigator
University of Alabama at Birmingham