Urinary BCAA Biomarker Detection for Early Insulin Resistance Screening
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Solution Overview
Problem
Current methods for screening insulin resistance and related chronic diseases like Type 2 Diabetes (T2D) and cardiovascular diseases (CVD) are invasive, complex, and not suitable for mass screening, lacking easily usable tools for early detection and prevention.
Innovation Solution
Utilizing urinary branched-chain amino acids (uBCAAs) as biomarkers, detected through a simplified enzymatic reaction network involving Leucine dehydrogenase (LeuDH), with a colorimetric readout, to assess insulin resistance risk and nutritional needs, employing DNA-free synthetic biology principles and microfluidic processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If blood assays (HOMA, QUICKI) or euglycaemic hyperinsulinaemic clamp are used to assess insulin resistance, then measurement precision is improved, but device complexity and ease of operation deteriorate due to invasive procedures and complex laboratory requirements
Solution Approach 1:
The patent extracts the insulin resistance assessment from complex blood-based procedures and isolates it to a simple urine-based test. By measuring urinary branched-chain amino acids (uBCAAs), the method removes the need for invasive blood draws, complex laboratory equipment, and specialized training, while maintaining diagnostic accuracy through the enzymatic reaction network that specifically detects uBCAA levels
Solution Approach 2:
The patent replaces the mechanical and laboratory-intensive blood assay system with a biochemical detection system based on enzymatic reactions. The enzymatic reaction network uses Leucine dehydrogenase to convert uBCAAs into measurable products, substituting complex mechanical laboratory procedures with a simpler biochemical detection mechanism that can be performed with basic equipment
2Measurement precision
If blood assays are used for insulin resistance screening, then measurement precision is improved, but ease of operation deteriorates due to invasive sampling and specialized laboratory requirements
Solution Approach 1:
The patent extracts the assessment function from complex blood-based testing and relocates it to urine sampling. Urine collection is non-invasive and can be performed by patients themselves, eliminating the need for phlebotomists, specialized laboratories, and complex operational protocols while maintaining the ability to accurately detect insulin resistance through uBCAA measurement
3Ease of operation
If simplified urine-based detection is used for mass screening, then ease of operation is improved, but measurement precision may deteriorate
Solution Approach 1:
The patent introduces an enzymatic reaction network as an intermediary between the simple urine sample and the diagnostic measurement. The enzymatic system (using Leucine dehydrogenase and other components) acts as a mediator that converts urinary BCAA levels into measurable signals with high precision, amplifying the detection capability while maintaining operational simplicity. This intermediary biochemical system ensures that the simplicity of urine collection does not compromise measurement accuracy
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Provides a rapid, accurate, and non-invasive method for early identification of insulin resistance and associated pathologies, with an accuracy of 88% compared to HOMA-IR index, facilitating early intervention and personalized nutritional regimens.
Implementation Method 1
The methodology relies on in silico design and accurate system modelling and simulation, as well as experimental production using for example a robust microfluidic process. They provide experimental evidence demonstrating the technological validity, and the advantages and efficiency of this novel diagnostic approach
Implementation Method 2
a proof of concept of an engineered simplified rapid IR test for the detection of uBCAA employing DNA free synthetic biology principles, which provide a colorimetric readout in response to an uBCAA threshold
Data Source
AI summary
The present invention is directed to method of determining whether a subject is at risk of developing insulin resistance, particularly for advance alert of T2D and or CVD onset in obese and non-obese subject, by detecting the branched-chain amino acids (BCAAs) present in an urine sample (uBCAAs) of the subjects. The present invention also relates to a method for determining the need of a dietary/nutritional supplement for a subject involving said uBCAAs biomarkers. Finally, the invention is directed to kit comprising the biochemical network allowing the uBCAAs detection and process for the preparation of said biochemical networks as diagnostic biomarker.