Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

HbA1c
12 months
Blood Glucose
12 months
Neurofilament Light
12 months
Glyoxylase 1 Activity
12 months
Body Mass Index
12 months
+2 more secondary outcomes

Study Arms (3)

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).

Eligibility Criteria

Age45 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Based on their pain status, subjects will be distributed into three groups: healthy, type 2 diabetes with painful neuropathy, and chronic low back pain. Subjects will not be randomized as our studies are based on comparisons of subjects within the 3 groups. The study team will assess for the presence of neuropathy by verbal confirmation of the subject. Subjects placed within the chronic low back pain group must have a diagnosis of chronic pain symptoms (persistent pain lasting longer than 3 months), as a direct result of lumbar disc aberrancy in the last 12 months. The study team will require diagnostic imaging to confirm aberrancy status for enrollment in this group.

You may qualify if:

Sponsors & Collaborators

University of Kansas Medical Center
Otherlead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Neuropathy, PainfulIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Doug Wright, PhD
University of Kansas Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

39 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Anatomy and Cell Biology

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 28, 2022

Study Start

May 2, 2022

Actual (reported)

Methylglyoxal Evaluation in Humans

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (3)

Healthy Control

Type 2 Diabetic with Painful Neuropathy

Chronic Low Back Pain as a Result of Lumber Disc Aberrancy

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (3)

Healthy Control

Type 2 Diabetic with Painful Neuropathy

Chronic Low Back Pain as a Result of Lumber Disc Aberrancy

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations