Methylglyoxal Evaluation in Humans (MEH)

University of Kansas

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT05350553

STUDY00148335

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

39 participants in 3 patient groups

Healthy Control

Description:

Patients 45-75 years of age without Type 2 Diabetes and without chronic low back pain.

Type 2 Diabetic with Painful Neuropathy

Description:

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

Description:

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).