Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- HbA1C
研究概览
简要总结
Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency, the investigators propose to determine if vitamin D treatment improves glycemic control in vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D treatment will improve glycemic control and ß-cell function in vitamin D deficient AA subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional glycemic control effects.
详细描述
Current literature suggests that 25-hydroxyvitamin D (25(OH)D) is inversely related to risk of type 2 diabetes mellitus (T2DM). African Americans (AA) have significantly less 25(OH)D concentrations, greater chances of poor glycemic control compared to European Americans (EA). The primary objective is to evaluate if the differences in glycemic control in children with type 2 diabetes are explained by differences in serum concentrations of 25(OH)D. A secondary aim is to demonstrate that subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) and T2DM who receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) have greater improvement than subjects who receive placebo in glycemic control, as measured by HbA1c and endogenous insulin secretion, as assessed by area under the concentration-time curve (AUC) for mixed meal-stimulated C peptide, at 3 months after study drug administration. Research design: Randomized, placebo-controlled, double blind study design in children with T2DM and vitamin D deficiency. Glycemic control will be determined by HbA1C levels, fasting glucose and area under the curve (AUC) for glucose after a mixed meal tolerance test (MMTT). Measures of beta cell function will be determined by AUC for c-peptide and glucose after MMTT. This study is warranted in AA adolescents with T2DM as any positive interventions could have life long impact and will lead to future larger clinical trials.
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
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •Type 2 DM with acanthosis
- •African American
- •12-18 years
- •BMI> 85%
- •Tanner Stage > 4
排除标准
- •Those taking vitamin D
- •Pregnancy
- •Those with chronic health conditions other than diabetes
- •Those who are deemed medically unstable to participate in research
结局指标
主要结局
HbA1C
时间窗: 3 -4 months
glycemic control
次要结局
- AUC for c-peptide and glucose after MMTT(3- 4months)
