Methylglyoxal Evaluation in Humans

Type 2 Diabetes Clinical Trial

— MEH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05350553
• Other study ID #: STUDY00148335
• Status: Not yet recruiting
• Start date: May 2, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2022
• Source: University of Kansas Medical Center
• Contact: Katherine Lane, BS
• Phone: 6366148955
• Email: klane7[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methylglyoxal Evaluation	Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain.	12 months
Secondary	HbA1c	Quantify blood HbA1c.	12 months
Secondary	Blood Glucose	Quantify non-fasting blood glucose (mg/dL).	12 months
Secondary	Neurofilament Light	Quantify circulating neurofilament light (NFL, pg/mL) proteins.	12 months
Secondary	Glyoxylase 1 Activity	Quantify glyoxylase 1 (GLO1, units) activity from blood cells.	12 months
Secondary	Body Mass Index	Height (cm) and weight (kg) will be combined to report body mass index (kg/m^2).	12 months
Secondary	Pain Status using the Brief Pain Index	Quantify patients' pain status using the Brief Pain Index (BPI).	12 months
Secondary	Neuropathy Status using the Michigan Neuropathy Screening Index	Quantify patients' neuropathy status using the Michigan Neuropathy Screening Index (MNSI).	12 months