Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Whole Body Insulin Sensitivity (WBISI)
研究概览
简要总结
The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D deficient obese children and adolescents will decrease the risk of getting diabetes (Disease in which the person has high blood sugar).
The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically over the past 30 years. There are some reports suggesting that vitamin D supplementation in adults with pre diabetes (blood glucose higher than normal) and vitamin D treatment will prevent diabetes.
详细描述
Participation will involve 3 visits (6 weeks apart) to the Clinical and Translational Science Institute (CTSI), which should happen 2-3 weeks after you have consented to participate in this study. The total duration of the study and the time you/your child will spend in the CTSI will be 2.5 hours for each visit.
Number of adolescents/children will enroll in this study:20.
Visit 1 A doctor will perform a complete physical examination. The child will have his/her weight and height measured .Blood pressure and vital signs will check each visit.
Of the 2 hours spent in the hospital, 1/2 hour is allocated to getting measurements, weight, and vitals and putting in an intravenous line and drawing fasting labs. The oral glucose tolerance test will take about 2 hours. To test for insulin sensitivity (Risk marker of Diabetes), oral Glucose Tolerance Test (OGTT) will be done. OGTT is used to diagnose Diabetes and Pre Diabetes. The child will first have blood samples drawn, and then will drink oral glucose soda. Blood samples will be obtained over 2 hours. A total of 5-7 teaspoons, which is 25-35 cc of blood will be taken during this test. Of this 15 cc will be drawn during the OGTT. A doctor or nurse will be monitoring the child throughout the test. If he/she develops low blood sugar, they will be treated appropriately with glucose.
Blood samples obtained at the start of the OGTT will be used to measure various markers of insulin sensitivity, vitamin D level and marker of bone health as vitamin D deficiency can causebone loss. This blood will be stored in the CTSI core laboratory in the CTSI for duration of this study. The blood samples will be stored without child's name or any other identifying information on them. The samples will be destroyed once the study is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese subjects - BMI at or above the 95th percentile for children of the same age and sex. Only obese subjects will be selected given that they are the highest risk group of developing insulin resistance and Type II Diabetes and therefore with be most likely to demonstrate glucose pertubation.
- •Pubertal: Testicular volume ≥ 6 ml Prader (M) and Tanner III breast development or greater (F)
- •12- 18 years regardless of gender, race or economic circumstance
- •Pre diabetes/high risk of diabetes using criteria of HbA1C between 5.7 - 6.4% as defined by the American Diabetes Association (ADA)
- •25-OH vitamin D level less than 20 ng/ml (50 nmol/liter)
- •Subjects must be willing to comply with study protocol requirements
排除标准
- •Treatment on medication known to effect vitamin D, calcium and glucose metabolism, such as glucocorticoids, thiazolidinediones, metformin, anticonvulsants metabolized through cytochrome P-450 (phenytoin, carbamazepine, phenobarbital, sodium valproate).
- •Subjects will be excluded from the study if they have taken any form of vitamin D supplementation greater than 400 IU daily in the preceding 3 months.
- •Significant major organ system illness
- •History of nephrolithiasis or hypercalcemia
- •Females who are pregnant
- •Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse, and uncontrolled major depression.
- •Attendance at tanning salon
研究组 & 干预措施
Placebo group
Placebo group B: single blinded to patients, receive 6 capsule PO (placebo) at once.
Subjects are blinded then they will crossover groups
干预措施: Placebo (Drug)
Treatment group
Group A will receive 6 capsules (50.000 units/each) of vitamin D2(ergocalciferol) at once.
Subjects are blinded then they will crossover groups.
干预措施: Vitamin D2 (Drug)
结局指标
主要结局
Whole Body Insulin Sensitivity (WBISI)
时间窗: 18 weeks
measured by the OGTT
Insulinogenic index
时间窗: 18 weeks
meassured by OGT
次要结局
- PTH level(18 weeks)
- Vitamin D toxicity(18 weeks)
- Vitamin D 25 OH(18 weeks)