Methylglyoxal Evaluation in Humans

Completed

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

• Registration Number: NCT05350553
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-28
• Study Start: 2022-05-02
• Status Verified: 2025-04
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Methylglyoxal Evaluation	12 months	Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States