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Completed

NCT Number: NCT05350553

Methylglyoxal Evaluation in Humans

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Methylglyoxal Evaluation

    Time frame: 12 months

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

Secondary outcomes

  1. HbA1c

    Time frame: 12 months

    Quantify blood HbA1c.

  2. Blood Glucose

    Time frame: 12 months

    Quantify non-fasting blood glucose (mg/dL).

  3. Neurofilament Light

    Time frame: 12 months

    Quantify circulating neurofilament light (NFL, pg/mL) proteins.

  4. Glyoxylase 1 Activity

    Time frame: 12 months

    Quantify glyoxylase 1 (GLO1, units) activity from blood cells.

  5. Body Mass Index

    Time frame: 12 months

    Height (cm) and weight (kg) will be combined to report body mass index (kg/m^2).

  6. Pain Status using the Brief Pain Index

    Time frame: 12 months

    Quantify patients' pain status using the Brief Pain Index (BPI).

  7. Neuropathy Status using the Michigan Neuropathy Screening Index

    Time frame: 12 months

    Quantify patients' neuropathy status using the Michigan Neuropathy Screening Index (MNSI).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: MEH

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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