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Completed

NCT Number: NCT01824017

Validation of an RLIP76 Assay in Humans

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..

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood Draw

Other

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2013
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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