Methylglyoxal Evaluation in Humans

NCT05350553 | Completed

• 1 other identifier: STUDY00148335
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Methylglyoxal Evaluation

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

  12 months

Secondary Outcomes (7)

• HbA1c

  12 months

• Blood Glucose

  12 months

• Neurofilament Light

  12 months

• Glyoxylase 1 Activity

  12 months

• Body Mass Index

  12 months

Study Arms (3)

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).

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Informed consent provided by the subject
• Able to read/speak English
• TYPE 2 DIABETES
• Blood glucose levels \> 126 mg/dl
• Diagnosed with neuropathy or experience painful numbness or tingling in their hands or feet
• LOW BACK PAIN
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Neuropathy, Painful; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Doug Wright, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anatomy and Cell Biology

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 28, 2022
• Study Start: May 2, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)