Validation of an RLIP76 Assay in Humans

City of Hope Medical Center35 enrolled

Overview

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..

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Blood DrawOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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)

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Outcomes

Primary Outcomes

The consistency of an ELISA-based RLIP76 assay in the serum of human subjects with metabolic syndrome.

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

Time frame: 12 months

Secondary Outcomes

Effect size of correlation of RLIP76 levels with treatment measures of metabolic syndrome such as hemoglobin A1c, LDL, and triglyceride levels.

The investigators will perform a longitudinal correlative study to evaluate the correlation of RLIP76 levels with changes in treatment measures of metabolic syndrome, such as hemoglobin A1c, LDL, and triglyceride levels. The results of this objective will be used to design a correlative study to determine the correlation of RLIP76 levels to the change in treatment measures of metabolic syndrome.

Time frame: 12 months

Data from ClinicalTrials.gov

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