Methylglyoxal Evaluation in Humans (MEH)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Doug Wright, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Back Pain; Intervertebral Disc Displacement; Low Back Pain
• Other Study ID Numbers: STUDY00148335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No