Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change in BMI z-score between the two dietary groups
研究概览
简要总结
The purpose of this study are to:
- compare two diet plans - a low-glycemic load (low-GL) diet and a low-fat diet. A low-GL diet is expected to keep blood sugar levels more normal, and because the sugar levels stay normal, prevent rapid rises of insulin in the blood. We want to test if Hispanic children at-risk for type 2 diabetes who are given a low-GL diet will have less insulin resistance, will lose more weight, and will decrease their chance of getting type 2 diabetes.
- compare the effects of Low-GL and high-GL meals on appetitive, hormonal, and metabolic responses of obese Hispanic youth under controlled, standardized conditions. We want to test if children fed low-GL meals would have lower glucose and lower insulin responses, report less hunger and consume less energy than those fed high-GL meals.
详细描述
Overweight among minority children and adolescents is now the most prevalent pediatric public health problem in the United States. Our preliminary studies have found the prevalence of overweight among Hispanic children and adolescents in Washington DC is more than twice the U.S. national average. It is well established that overweight is associated with both medical and psychosocial complications, particularly for minority populations. Study of overweight Hispanic children has shown that they are at high risk for insulin resistance and impaired glucose tolerance (IGT), with IGT present in 28% of overweight Latino children with a family history of type 2 diabetes (T2DM). Despite the urgency to develop effective strategies to treat obesity and prevent T2DM in such children, few randomized controlled trials of weight management have been conducted in Hispanic children. Hence, there is an urgent need to develop effective, feasible and culturally competent obesity treatment programs targeted to Hispanic youth who are at great risk for obesity-associated co-morbidities, and who represent the fastest growing segment of the U.S. population.
A low-glycemic index (GI) or glycemic load (GL) diet is a much discussed, but quite controversial treatment of obesity. Some, but not all epidemiological studies show lower risk of diabetes among individuals consuming a low-GL diet. Short-term clinical studies examining the hormonal and biochemical responses to a low-GI diet have documented a reduction of reactive hyperglycemia and hyperinsulinemia, and decrease food intake. We propose that a low GL diet may be a particularly effective dietary regimen for overweight Latino children at risk for T2DM, who have a high consumption of processed and refined carbohydrate foods. The overall aim of this project is to determine the hormonal, metabolic, and body composition changes that occur during a two-year period of consumption of low-GL meals compared to low fat meals among Latino children at risk for T2DM. Our specific aims are:
- Specific Aim 1: To study the short- and long-term effects of a low-GL diet on insulin sensitivity in overweight Latino children at risk for T2DM.
Hypothesis 1: Insulin sensitivity will increase to a greater extent in children randomized to a low-GL diet than in children randomized to a reduced-fat meal prescription after 3, 12, and 24 months. The increase in insulin sensitivity found with a low-GL diet will not be fully explained by changes in BMI alone.
- Specific Aim 2: To determine the short- and long-term effects of a low-GL diet on BMI z-score and body fat changes in overweight Latino children at risk for T2DM.
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
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hispanic children aged 7-14 years with BMI >= 95th percentile at risk for T2DM and who are otherwise healthy
- •Ethnicity will be by self-identification with the Hispanic or Latino cultural group by the subject's parents and both sets of grandparents.
- •At risk for T2DM defined as a positive family history of T2DM plus insulin resistance (fasting hyperinsulinemia ≥ 15 uIU/mL) or impaired glucose tolerance (fasting glucose >110 mg/dl, or 2-hour postglucose challenge >140 mg/dl).
- •Only one child per family will be eligible to participate in the study
排除标准
- •pre-existing T2DM
- •Cushing syndrome
- •untreated hypothyroidism
- •pervasive developmental disorder
- •severe asthma
- •severe untreated depression
- •use of medications that promote weight gain or loss
- •obesity-associated genetic syndromes (e.g. Prader Willi syndrome)
结局指标
主要结局
Change in BMI z-score between the two dietary groups
时间窗: 3-, 12-, and 24 months
Change in insulin sensitivity between the two dietary arms
时间窗: at 3-, 12- and 24 months
次要结局
- Change in body fat mass, lipid assay (LDL cholesterol, TG, FFA) between the two dietary arms(3-, 12-, and 24 months)
- Differences in subjective, hormonal, and metabolic between the two dietary arms(3 months)
研究者
Nazrat Mirza
Associate Professor
Children's National Research Institute