Validation of an RLIP76 Assay in Humans

NCT01824017 | Completed DMC

• 1 other identifier: 12044
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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..

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; metabolic syndrome; oxidative stress; GSH

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

Blood Draw

OTHER

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

Other: Blood Draw

Interventions

Blood Draw OTHER

Blood Draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Raynald Samoa, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: April 4, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (1)