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MEH: Methylglyoxal Evaluation in Humans

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05350553
Collaborator
(none)
45
Enrollment
19
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    45 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Cross-Sectional Trial of Methylglyoxylated-Protein Levels in Adults With Chronic Pain
    Anticipated Study Start Date :
    May 2, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Methylglyoxal Evaluation [12 months]

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

    Secondary Outcome Measures

    1. HbA1c [12 months]

      Quantify blood HbA1c.

    2. Blood Glucose [12 months]

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

    3. Neurofilament Light [12 months]

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

    4. Glyoxylase 1 Activity [12 months]

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

    5. Body Mass Index [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 [12 months]

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

    7. Neuropathy Status using the Michigan Neuropathy Screening Index [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Kansas Medical Center

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Doug Wright, Professor of Anatomy and Cell Biology, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT05350553
    Other Study ID Numbers:
    • STUDY00148335
    First Posted:
    Apr 28, 2022
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intervertebral Disc Displacement
    Low Back Pain

    Study Results

    No Results Posted as of Apr 28, 2022