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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Patients 45-75 years of age without Type 2 Diabetes and without chronic low back pain. | ||
| Type 2 Diabetic with Painful Neuropathy | 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 | 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Methylglyoxal Evaluation | Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Quantify blood HbA1c. | 12 months |
| Blood Glucose | Quantify non-fasting blood glucose (mg/dL). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Based on their pain status, subjects will be distributed into three groups: healthy, type 2 diabetes with painful neuropathy, and chronic low back pain. Subjects will not be randomized as our studies are based on comparisons of subjects within the 3 groups. The study team will assess for the presence of neuropathy by verbal confirmation of the subject. Subjects placed within the chronic low back pain group must have a diagnosis of chronic pain symptoms (persistent pain lasting longer than 3 months), as a direct result of lumbar disc aberrancy in the last 12 months. The study team will require diagnostic imaging to confirm aberrancy status for enrollment in this group.
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| Name | Affiliation | Role |
|---|---|---|
| Doug Wright, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2022 | Apr 13, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| C564945 | Neuropathy, Painful |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D004700 | Endocrine System Diseases |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |