Validation of RLIP76 Assay and Exploratory Study of RLIP76 Correlation Among Patients With Type 2 Diabetes and Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The consistency of an ELISA-based RLIP76 assay in the serum of human subjects with metabolic syndrome.
研究概览
简要总结
The current proposal extends work done in mouse models evaluating the consistency of measuring RLIP76 in a clinical cohort (Aim 1) by using guidelines provided by the NIH for validating biomarkers. We will also proceed to estimate the effect size of a potential correlation of RLIP76 with standard MsY treatment measures such as hgbA1c, LDL, and triglyceride levels in a longitudinal prospective study ( Aim 2) that will follow a cohort of patients with MsY who seek care at the City of Hope Endocrine clinic over a 12 month period..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered patient of City of Hope and followed in the Endocrine Clinic. Must have documentation of a diagnosis of diabetes identified by the problem list in the patient's electronic health record.
- •Must demonstrate features of MsY by possessing any of the following characteristics and/or receiving treatment for diabetes, hyperlipidemia, and/or hypertriglyceridemia.
- •Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches (female)
- •Dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl)
- •Dyslipidemia: HDL-C < 40 mg/dL (male), < 50 mg/dL (female)
- •Blood pressure ≥ 130/85 mmHg
- •Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)
排除标准
- 未提供
研究组 & 干预措施
Blood Draw
Data will be collected at patients' usual follow-up intervals for monitoring their metabolic conditions (i.e., T2D, hyperlipidemia, hypertriglyceridemia, etc.), which will be at 3 or 6 month intervals with a +/- 30 day window. Standard treatment surveillance measures such as hemoglobin A1c, LDL, and triglyceride levels will be performed as the standard of care for patients with MsY. Blood samples for these tests will be drawn while subjects are fasting
干预措施: Blood Draw (Other)
结局指标
主要结局
The consistency of an ELISA-based RLIP76 assay in the serum of human subjects with metabolic syndrome.
时间窗: 12 months
The investigators will perform 6 repeated measurements on first blood draws from patients with Type 2 diabetes who also have MsY. Sixty-seven percent (4 out of 6) of the quality controls must be within 15% of the mean of these measurements for us to consider the ELISA-based RLIP76 assay to be consistent
次要结局
- Effect size of correlation of RLIP76 levels with treatment measures of metabolic syndrome such as hemoglobin A1c, LDL, and triglyceride levels.(12 months)