Methylglyoxal Evaluation in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-02

Study Completion Date

2025-04-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Control

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

No interventions assigned to this group

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)

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes