Methylglyoxal Evaluation in Humans

Study Overview
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Brief Summary
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The investigators will test the hypothesis that patients with low back pain associated with lumbar disc aberrancy will have elevated MGO-protein levels circulating in the blood that are comparable to patients with painful diabetic neuropathy.

Detailed Description
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This is a cross-sectional, non-interventional study conducted solely at KU Medical Center in which patients will be recruited and sorted based on the following status: 1) healthy, 2) painful diabetic neuropathy, 3) chronic low back pain as a result of non-operative lumbar aberrancy. Once recruited, subjects will undergo a venous blood draw to measure MGO-protein levels, HbA1c, blood glucose, NFL protein levels and GLO1 activity. Subjects will also complete questionnaires to better understand how MGO levels correlate with pain status.

Official Title
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A Cross-Sectional Trial of Methylglyoxylated-Protein Levels in Adults With Chronic Pain

Conditions
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Type 2 Diabetes, Neuropathy, Painful, Chronic Low-back Pain, Lumbar Disc Herniation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent provided by the subject Able to read/speak English TYPE 2 DIABETES All healthy inclusion criteria AND Blood glucose levels > 126 mg/dl Diagnosed with neuropathy or experience painful numbness or tingling in their hands or feet LOW BACK PAIN All healthy inclusion criteria AND Chronic (persistent pain lasting longer than 3 months) low back pain as a direct result of non-operative lumbar disc aberrancy (disc herniation, protrusion, or extrusion) Aberrancy occurring within 12 months of pre-screening Exclusion Criteria: Prisoner Current clinically significant cardiac or neurological disease Diagnosis of IBS, osteoarthritis, fibromyalgia, complex regional pain syndrome (CRPS), postherpetic neuralgia Lumbar surgery due to disc aberrancy Therapeutic spinal injections within the last 3 months (steroid, ablations, etc.) Chronic use of steroids or non steroidal anti-inflammatory drugs (NSAIDS) within 3 months of pre-screen Past or present use of spinal cord stimulators

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Control<br>Patients 45-75 years of age without Type 2 Diabetes and without chronic low back pain. | |
| Type 2 Diabetic with Painful Neuropathy<br>Patients 45-75 years of age with Type 2 Diabetes and experiencing painful neuropathy (painful numbness or tingling in hands and/or feet) | |
| Chronic Low Back Pain as a Result of Lumber Disc Aberrancy<br>Patients 45-75 years of age with chronic low back pain as a direct result of non-operative lumber disc aberrancy (lumbar disc herniation, protrusion, or extrusion). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylglyoxal Evaluation | Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Quantify blood HbA1c. | 12 months | 
| Blood Glucose | Quantify non-fasting blood glucose (mg/dL). | 12 months | 
| Neurofilament Light | Quantify circulating neurofilament light (NFL, pg/mL) proteins. | 12 months | 
| Glyoxylase 1 Activity | Quantify glyoxylase 1 (GLO1, units) activity from blood cells. | 12 months | 
| Body Mass Index | Height (cm) and weight (kg) will be combined to report body mass index (kg/m^2). | 12 months | 
| Pain Status using the Brief Pain Index | Quantify patients' pain status using the Brief Pain Index (BPI). | 12 months | 
| Neuropathy Status using the Michigan Neuropathy Screening Index | Quantify patients' neuropathy status using the Michigan Neuropathy Screening Index (MNSI). | 12 months |