Diabetes Risk Index (DRI)

CPT: 81599
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Specimen Requirements


Specimen

Serum, shipped refrigerated, or plasma


Volume

1 mL


Minimum Volume

0.5 mL


Container

Lavender-top (EDTA-no gel) tube (preferred) or plain red-top tube or NMR LipoTube (black-and-yellow-top tube); green-top (Na heparin) plasma tube is also acceptable


Collection

Collect specimen in a lavender-top (EDTA-no gel) tube, which is the preferred specimen. For specimens collected in plain red-top tube, hold tube upright at room temperature for 45 minutes and allow to clot. Centrifuge specimen after clotting according to manufacturer's specifications. Transfer to a transport tube for storage at (2°C to 8°C) until shipped. For NMR LipoTube (black-and-yellow-top tube), keep upright at room temperature for 30 minutes and allow to clot. Centrifuge at 1800 to 2200xg for 10 to 15 minutes immediately after clotting. If the sample cannot be centrifuged immediately, it must be refrigerated at (2°C to 8°C) and centrifuged within 24 hours of collection. The NMR tube should then be stored at (2°C to 8°C) until shipped. Do not open NMR LipoTube. Separate plasma from lavender-top (EDTA-no gel) tube or green-top (heparin-no gel) tube immediately after collection and transfer to a plastic transport tube for shipment to the laboratory. Serum or plasma drawn in gel-barrier collection tubes other than the NMR LipoTube should not be used.


Storage Instructions

Refrigerate prior to shipment, and ship on frozen cool packs.


Stability Requirements

Temperature

Period

Room temperature

Lipotube Serum: 1 day; Plain Serum: 1 day; EDTA Plasma: 8 hours; Sodium Heparin Plasma: 8 hours

Refrigerated

Lipotube Serum: 8 days; Plain Serum: 8 days; EDTA Plasma: 8 days; Sodium Heparin Plasma: 7 days

Frozen

All tubes: 15 days

Freeze/thaw cycles

Lipotube Serum: Stable x5; Plain Serum: Stable x1; EDTA Plasma: Stable x5; Sodium Heparin Plasma: Stable x2


Patient Preparation

Fasting for 10 to 12 hours is recommended.


Causes for Rejection

Unspun LipoTube or unseparated plain red-top or EDTA tube; serum or plasma specimen drawn in gel-barrier collection tube other than the NMR LipoTube


Test Details


Use

The Diabetes Risk Index (DRI) is intended for use in adult subjects for the quantitative determination of a risk score in serum or plasma. The DRI score (1-100) may be used as an aid in stratifying the risk of developing type 2 diabetes in individuals with normo-glycemia or prediabetes.


Limitations

Measurements from plasma specimens are on average 8 points lower than from serum specimens.

Note: The results of the freeze/thaw study for the plain serum samples showed a 10% increase in DRI upon the first freeze/thaw cycle and no further changes upon successive freeze/thaw cycles.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

Nuclear magnetic resonance (NMR)


Reference Interval

Diabetes Risk Index (DRI) Cut Points

Male

Female

Low risk:

<50

<40

Intermediate risk:

50−65

40−55

High risk:

>65

>55


Additional Information

The Diabetes Risk Index (DRI) is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA).1-7

LP-IR is a marker of insulin resistance, and as such the LP-IR score predicts a patient's likelihood of future development of T2D.1-4 LP-IR is a multimarker index (values 0-100) based on the concentrations of particular lipoprotein subclasses [very large and large triglyceride-rich lipoprotein particles (VLL-TRLP), small low density lipoprotein particles (S-LDLP), large high density lipoprotein particles (L-HDLP), and mean TRL, LDL, and HDL particle sizes (TRLZ, LDLZ, HDLZ)]. The medical decision limits established for LPIR are <50 (low), 50-80 (intermediate), and >80 (high) with these cutpoints corresponding to the 25th and 75th percentiles in a normal population. DRI builds on the effective insulin resistance assessment by LP-IR and adds the measurement of BCAA. Similar to LP-IR, BCAA have also been shown to predict incident T2DM.5,6 The analytes contributing to DRI are measured by mathematical deconvolution of the methyl signal region of the plasma/serum NMR spectrum. This algorithm is different from the NMR LipoProfile test in that the methyl region is extended downfield to include signals from the BCAA (valine and leucine).

For clinical use, DRI can be divided into three groups, corresponding to a low, intermediate, and high risk of developing T2D, with cutpoints corresponding closely to the 40th and 80th percentile values in the Multi-Ethnic Study of Atherosclerosis (MESA) reference population, using gender-specific cutpoints. Therefore, the low DRI category would include men and women with DRI scores less than 50 and 40, respectively. The intermediate DRI category would include men with DRI 50-65 and women with DRI 40-55. The high DRI group would consist of men and women with DRI >65 and >55, respectively.


Footnotes

1. Shalaurova I, Connelly MA, Garvey WT, Otvos JD. Lipoprotein insulin resistance index: a lipoprotein particle-derived measure of insulin resistance. Metab Syndr Relat Disord. 2014 Oct;12(8):422-429.24959989
2. Mackey RH, Mora S, Bertoni AG, et al. Lipoprotein particles and incident type 2 diabetes in the multi-ethnic study of atherosclerosis. Diabetes Care. 2015 Apr;38(4):628-636.25592196
3. Harada PHN, Demler OV, Dugani SB, et al. Lipoprotein insulin resistance score and risk of incident diabetes during extended follow-up of 20 years: The Women's Health Study. J Clin Lipidol. 2017 Sep-Oct;11(5):1257-1267.e2.28733174
4. Flores-Guerrero JL, Connelly MA, Shalaurova I, et al. Lipoprotein insulin resistance index, a high-throughput measure of insulin resistance, is associated with incident type II diabetes mellitus in the Prevention of Renal and Vascular End-Stage Disease study. J Clin Lipidol. 2019 Jan-Feb;13(1):129-137.e1.30591414
5. Wolak-Dinsmore J, Gruppen EG, Shalaurova I, et al. A novel NMR-based assay to measure circulating concentrations of branched-chain amino acids: Elevation in subjects with type 2 diabetes mellitus and association with carotid intima media thickness. Clin Biochem. 2018 Apr;54:92-99.29432757
6. Flores-Guerrero JL, Osté MCJ, Kieneker LM, et al. Plasma Branched-Chain Amino Acids and Risk of Incident Type 2 Diabetes: Results from the PREVEND Prospective Cohort Study. J Clin Med. 2018 Dec 4;7(12).30518023
7. Flores-Guerrero JL, Gruppen EG, Connelly MA, et al. A Newly Developed Diabetes Risk Index, Based on Lipoprotein Subfractions and Branched Chain Amino Acids, is Associated with Incident Type 2 Diabetes Mellitus in the PREVEND Cohort. J Clin Med. 2020 Aug 27;9(9):2781.32867285

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
123855 Diabetes Risk Index (DRI) 123856 Diabetes Risk Index (DRI) 94560-0
123855 Diabetes Risk Index (DRI) 123857 References: N/A

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