Methods and compositions for diagnosis and management of diabetes and metabolic syndrome
Inventors
Assignees
Office of General Counsel of VA • University of South Florida St Petersburg
Publication Number
US-10724097-B2
Publication Date
2020-07-28
Expiration Date
2035-11-30
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Abstract
Described herein are assays, methods, and devices for diagnosing/prognosing diabetes, metabolic syndrome, pre-diabetic state and/or the early-onset of diabetes in a subject. The assays, methods, and devices described herein can be configured to detect one or more long-coding RNAs in a sample from a subject.
Core Innovation
The invention provides assays, methods, and devices for diagnosing or prognosing diabetes, metabolic syndrome, pre-diabetic state, and early onset of diabetes in a subject by detecting one or more long non-coding RNAs (lncRNAs) in samples from the subject. The assays involve using capture molecules configured to specifically bind to biomarkers selected from a defined group of lncRNAs, such as GAS5 (SNHG2), 21A, 7sl, anti-nos2a, and others, detecting specific binding, quantifying the biomarker amount, and making a diagnosis or prognosis based on comparison with controls or predetermined thresholds.
The assays can be applied to bodily fluids including blood serum, whole blood, saliva, or urine, and samples can be obtained from subjects having or suspected of having diabetes or metabolic syndrome, including non-obese and obese subjects. Detection techniques may include PCR-based methods, nucleotide sequencing, in situ hybridization, and other molecular biology techniques. The invention further provides kits containing capture molecules to specifically bind these biomarkers along with instructions for diagnosing or prognosing diabetes-related conditions.
The background identifies the problem that current diagnostic markers for diabetes do not indicate the initial stages of developing diabetes, such as the pre-diabetic state, and there is a need for improved diagnostic methods. LncRNAs have varied cellular functions but their involvement in diabetes or metabolic syndrome was previously unknown. The invention addresses this need by providing assays targeting specific lncRNAs whose expression levels differ between diabetic and non-diabetic subjects, allowing earlier and more accurate diagnosis and prognosis of diabetes and metabolic syndrome.
Claims Coverage
The patent contains five claims including one independent claim. The main inventive features relate to a method of detecting GAS5 lncRNA levels in blood serum samples from non-obese subjects for diagnosing diabetes.
Method of detecting GAS5 lncRNA in blood serum
Obtaining a blood serum sample from a non-obese subject and detecting an amount of GAS5 lncRNA present in the blood serum sample lower than 10 ng/μl by contacting the sample with one or more polynucleotides capable of specifically binding GAS5 lncRNA.
Detection in undiagnosed subjects
Detection can be performed in subjects not diagnosed with diabetes, enabling early identification of predisposition or prediabetes.
Sequence identity of GAS5 lncRNA
The GAS5 lncRNA detected can have a sequence that is 80%-100% identical to SEQ ID NO: 12, specifying the biomarker's nucleic acid identity.
Detection using molecular biology techniques
The detecting step can employ various molecular techniques including microarray PCR, qPCR, real-time PCR, RT-PCR, digital PCR, RNA flare, RNA flow cytometry, nucleotide sequencing, in situ hybridization, northern blot analysis, and combinations thereof.
Use of specific polynucleotides
The one or more polynucleotides used for specific binding are selected from the group consisting of SEQ ID NO: 1-2, ensuring target specificity.
The claims collectively cover a diagnostic method for early detection of diabetes or predisposition in non-obese subjects by quantifying decreased levels of GAS5 lncRNA in blood serum using specific polynucleotide probes and established nucleic acid detection techniques.
Stated Advantages
Provides earlier, improved, and more accurate diagnosis and prognosis of diabetes and metabolic syndrome compared to conventional methods.
Detection of long non-coding RNA biomarkers allows identification of pre-diabetic states and early onset of diabetes.
Assays can be performed on minimally invasive bodily fluids such as blood serum, saliva, or urine.
The method allows monitoring of the response to treatment or management of diabetes and metabolic syndrome.
GAS5 levels serve as a predictive marker independent of patient age, BMI, and fasting blood glucose levels.
Documented Applications
Diagnosing or prognosing diabetes, metabolic syndrome, pre-diabetic state, or early onset of diabetes in a subject by detecting long non-coding RNAs in bodily fluids.
Evaluation of response to treatment or management of diabetes and metabolic syndrome through quantification of specific lncRNA biomarkers.
Use in clinical assessment of non-obese and obese subjects suspected of or predisposed to diabetes.
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