Validation of an RLIP76 Assay in Humans

City of Hope

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Blood Draw

Study type: Interventional

Funder types: Other

Identifiers

NCT01824017

12044

Details and patient eligibility

About

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..

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Blood Draw

Other group

Description:

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

Treatment:

Other: Blood Draw