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Validation of an RLIP76 Assay in Humans

Validation of RLIP76 Assay and Exploratory Study of RLIP76 Correlation Among Patients With Type 2 Diabetes and Metabolic Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01824017
Enrollment
35
Registered
2013-04-04
Start date
2012-12-31
Completion date
2016-09-30
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes, metabolic syndrome, oxidative stress, GSH

Brief summary

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..

Interventions

OTHERBlood Draw

Sponsors

City of Hope Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The consistency of an ELISA-based RLIP76 assay in the serum of human subjects with metabolic syndrome.12 monthsThe 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

Secondary

MeasureTime frameDescription
Effect size of correlation of RLIP76 levels with treatment measures of metabolic syndrome such as hemoglobin A1c, LDL, and triglyceride levels.12 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026