Validation of an RLIP76 Assay in Humans

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Blood Draw

• Registration Number: NCT01824017
• Lead Sponsor: City of Hope Medical Center

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..

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Draw	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect size of correlation of RLIP76 levels with treatment measures of metabolic syndrome such as hemoglobin A1c, LDL, and triglyceride levels.	12 months	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States