Methylglyoxal Evaluation in Humans

University of Kansas Medical Center39 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Methylglyoxal Evaluation

Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain.

Time frame: 12 months

Secondary Outcomes

HbA1c

Quantify blood HbA1c.

Time frame: 12 months

Blood Glucose

Quantify non-fasting blood glucose (mg/dL).

Time frame: 12 months

Neurofilament Light

Quantify circulating neurofilament light (NFL, pg/mL) proteins.

Time frame: 12 months

Glyoxylase 1 Activity

Quantify glyoxylase 1 (GLO1, units) activity from blood cells.

Time frame: 12 months

Body Mass Index

Height (cm) and weight (kg) will be combined to report body mass index (kg/m\^2).

Time frame: 12 months

Pain Status using the Brief Pain Index

Quantify patients' pain status using the Brief Pain Index (BPI).

Time frame: 12 months

Neuropathy Status using the Michigan Neuropathy Screening Index

Quantify patients' neuropathy status using the Michigan Neuropathy Screening Index (MNSI).

Time frame: 12 months

Data from ClinicalTrials.gov

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