Clinical trial NCT05350553: Methylglyoxal Evaluation in Humans
Official title: A Cross-Sectional Trial of Methylglyoxylated-Protein Levels in Adults With Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Neuropathy, Painful
Chronic Low-back Pain
Lumbar Disc Herniation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 39
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Methylglyoxal Evaluation
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Blood Glucose
timeFrame: 12 months
measure: Neurofilament Light
timeFrame: 12 months
measure: Glyoxylase 1 Activity
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 12 months
measure: Pain Status using the Brief Pain Index
timeFrame: 12 months
measure: Neuropathy Status using the Michigan Neuropathy Screening Index
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Doug Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: