Status:

COMPLETED

Methylglyoxal Evaluation in Humans

Lead Sponsor:

University of Kansas Medical Center

Conditions:

Type 2 Diabetes

Neuropathy, Painful

Eligibility:

All Genders

45-75 years

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 ...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 2 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2025

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT05350553

Start Date

May 2 2022

End Date

April 1 2025

Last Update

April 4 2025

Active Locations (1)

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1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160