Type 2 DiabetesMEHNCT05350553
Methylglyoxal Evaluation in Humans
An observational study of Type 2 Diabetes and Neuropathy, Painful, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Neuropathy, Painful, Chronic Low-back Pain
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Cross-Sectional Trial of Methylglyoxylated-Protein Levels in Adults With Chronic Pain
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.
Read the 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.
- Medical subject headings
- Diabetes Mellitus, Type 2, Neuropathy, Painful, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylglyoxal Evaluation
Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain.
Measured: 12 months
Secondary outcomes (7)
HbA1c
Quantify blood HbA1c.
Measured: 12 months
Blood Glucose
Quantify non-fasting blood glucose (mg/dL).
Measured: 12 months
Neurofilament Light
Quantify circulating neurofilament light (NFL, pg/mL) proteins.
Measured: 12 months
Glyoxylase 1 Activity
Quantify glyoxylase 1 (GLO1, units) activity from blood cells.
Measured: 12 months
Body Mass Index
Height (cm) and weight (kg) will be combined to report body mass index (kg/m^2).
Measured: 12 months
Pain Status using the Brief Pain Index
Quantify patients' pain status using the Brief Pain Index (BPI).
Measured: 12 months
Neuropathy Status using the Michigan Neuropathy Screening Index
Quantify patients' neuropathy status using the Michigan Neuropathy Screening Index (MNSI).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start2 May 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doug Wright, University of Kansas Medical Center
- Investigators
- Doug Wright, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350553
- Sponsor's protocol ID
- STUDY00148335
- Acronym
- MEH
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Trial of Methylglyoxylated-Protein Levels in Adults With Chronic Pain
- ClinicalTrials.gov ID
- NCT05350553
- Acronym / sponsor ID
- MEH / STUDY00148335
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Methylglyoxal Evaluation
Time frame: 12 months
Number of participants with elevated blood methylglyoxal-derived hydroimidazolone (MG-H1, nM) with chronic pain.
7 secondary outcomes
HbA1c
Time frame: 12 months
Blood Glucose
Time frame: 12 months
Neurofilament Light
Time frame: 12 months
Glyoxylase 1 Activity
Time frame: 12 months
Body Mass Index
Time frame: 12 months
Pain Status using the Brief Pain Index
Time frame: 12 months
Neuropathy Status using the Michigan Neuropathy Screening Index
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Wright, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Neuropathy, Painful, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylglyoxal Evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.