Validation of an RLIP76 Assay in Humans

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824017
• Other study ID #: 12044
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: September 7, 2016
• Start date: December 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Blood Draw

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Effect size of correlation of RLIP76 levels with treatment measures of metabolic syndrome such as hemoglobin A1c, LDL, and triglyceride levels.	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.	12 months	No