Diabetes MellitusNCT06754813
Association Between Uric Acid / High Density Lipoprotein Ratio and Monocyte / High Density Lipoprotein Ratio With Diabetic Complications
An observational study of Diabetes Mellitus, run by Assiut University.
Trial summary
Type 2 diabetes mellitus (T2DM) poses a formidable global health challenge, with complications arising in both the microvascular and macrovascular domains as glycemic control worsens.the aim of the study to evaluate uric acid / high density lipoprotein cholesterol ratio and monocyte / high density lipoprotein ratio in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: diabetic patients who attending the Diabetes Clinic of Internal Medicine Department, Assiut University Hospital from January 2025 till January 2026.
Who may be able to join
- type 2 diabetic patients
- age more than 18 years old
- both sex
Who cannot join
- Individuals with malignancies, pregnant women, those using furosemide, thiazide, acetylsalicylic acid, losartan group drugs, cholesterol lowering drugs, patients with other autoimmune disorders, patients with chronic kidney disease and gout.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Type 2 diabetes mellitus (T2DM) poses a formidable global health challenge, with complications arising in both the microvascular and macrovascular domains as glycemic control worsens.the aim of the study to evaluate uric acid / high density lipoprotein cholesterol ratio and monocyte / high density lipoprotein ratio in studied groups. Association between Uric Acid / high density lipoprotein cholesterol ratio and monocyte / high density lipoprotein cholesterol ratio and diabetic Complications (macrovascular and microvascular).
Read the detailed description
Hemoglobin A1c (HbA1c) continues to serve as the primary retrospective marker to assess glycemic management, but the inability to monitor daily blood glucose fluctuations remains a persistent concern
Uric acid is the final enzymatic product of purine nucleoside and free base degradation. Elevated levels of serum uric acid (SUA) are widely recognized as a risk factor for macrovascular and microvascular complications. Hyperuricemia is particularly common in patients with hyperlipidemia.
It has been established that SUA levels are proportional to triglyceride (TG), total cholesterol (TC), and low-density lipoprotein (LDL) levels. SUA promotes the oxidation of LDL, which is considered to be a key event in atherosclerotic plaque formation. The findings of several epidemiological studies have thus provided evidence to indicate a clear independent association between elevated SUA levels and an increased incidence of atherosclerotic disease or mortality Decreased serum levels of High-density lipoprotein cholesterol (HDL-c) are proposed to be related to worse metabolic status and reduced HDL-c is even a marker of metabolic syndrome.
A combination of these two metabolic parameters uric acid to HDL-c ratio (UHR) which is a more useful predictor of metabolic deterioration High-density lipoprotein- cholesterol acts by reducing proinflammatory responses triggered by monocytes, effectively restricting monocyte proliferation, activation and migration, and plays a role in the anti-oxidant mechanism. In contrast, reduced levels of HDL-c in the blood stream imply a worsening metabolic profile and are a component of the metabolic syndrome Uric acid can cause atherosclerosis and insulin resistance by reducing nitric oxide production, promoting vascular smooth muscle proliferation, and resulting in endothelial dysfunction. Additionally, low levels of HDL-c play a role in the development of metabolic syndrome and insulin resistance.
More recently, the uric acid-to-HDL-c ratio (UHR) has been identified as a marker that increases in inflammatory conditions . Monocytes and macrophages play crucial roles in damage to pancreatic islet cells, islet inflammation and impaired insulin signaling in T2DM. The monocyte/ HDL-c ratio (MHR) has been proposed as an indicator of ongoing low-grade metabolic inflammation and has been suggested studies to be used as a marker for cardiovascular disease and chronic kidney disease .
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
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 |
|---|---|---|
| group 1 | Diabetic patients without any macrovascular and microvascular Complications. | |
| group 2 | Diabetic patients with macrovascular (stroke, coronary heart disease, Peripheral artery disease) and microvascular (DN and DR) complications | |
| group 3 | Apparent healthy subjects as control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
uric acid / high density lipoprotein cholesterol ratio
Calculation of UHR was calculated by dividing serum uric acid value by HDL-c value
Measured: baseline
monocyte / high density lipoprotein ratio
calculated by dividing of count of monocyte by HDL-c level
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Gamal Abdelnaser, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754813
- Sponsor's protocol ID
- HDL Uric UHR monocyte MHR DM
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
PubMed 38078589
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Uric Acid / High Density Lipoprotein Ratio and Monocyte / High Density Lipoprotein Ratio With Diabetic Complications
- ClinicalTrials.gov ID
- NCT06754813
- Acronym / sponsor ID
- HDL Uric UHR monocyte MHR DM
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Jan 2025 (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.
Type 2 diabetes mellitus (T2DM) poses a formidable global health challenge, with complications arising in both the microvascular and macrovascular domains as glycemic control worsens.the aim of the study to evaluate uric acid / high density lipoprotein cholesterol ratio and monocyte / high density lipoprotein ratio in studied groups. Association between Uric Acid / high density lipoprotein cholesterol ratio and monocyte / high density lipoprotein cholesterol ratio and diabetic Complications (macrovascular and microvascular).
Detailed description
Hemoglobin A1c (HbA1c) continues to serve as the primary retrospective marker to assess glycemic management, but the inability to monitor daily blood glucose fluctuations remains a persistent concern
Uric acid is the final enzymatic product of purine nucleoside and free base degradation. Elevated levels of serum uric acid (SUA) are widely recognized as a risk factor for macrovascular and microvascular complications. Hyperuricemia is particularly common in patients with hyperlipidemia.
It has been established that SUA levels are proportional to triglyceride (TG), total cholesterol (TC), and low-density lipoprotein (LDL) levels. SUA promotes the oxidation of LDL, which is considered to be a key event in atherosclerotic plaque formation. The findings of several epidemiological studies have thus provided evidence to indicate a clear independent association between elevated SUA levels and an increased incidence of atherosclerotic disease or mortality Decreased serum levels of High-density lipoprotein cholesterol (HDL-c) are proposed to be related to worse metabolic status and reduced HDL-c is even a marker of metabolic syndrome.
A combination of these two metabolic parameters uric acid to HDL-c ratio (UHR) which is a more useful predictor of metabolic deterioration High-density lipoprotein- cholesterol acts by reducing proinflammatory responses triggered by monocytes, effectively restricting monocyte proliferation, activation and migration, and plays a role in the anti-oxidant mechanism. In contrast, reduced levels of HDL-c in the blood stream imply a worsening metabolic profile and are a component of the metabolic syndrome Uric acid can cause atherosclerosis and insulin resistance by reducing nitric oxide production, promoting vascular smooth muscle proliferation, and resulting in endothelial dysfunction. Additionally, low levels of HDL-c play a role in the development of metabolic syndrome and insulin resistance.
More recently, the uric acid-to-HDL-c ratio (UHR) has been identified as a marker that increases in inflammatory conditions . Monocytes and macrophages play crucial roles in damage to pancreatic islet cells, islet inflammation and impaired insulin signaling in T2DM. The monocyte/ HDL-c ratio (MHR) has been proposed as an indicator of ongoing low-grade metabolic inflammation and has been suggested studies to be used as a marker for cardiovascular disease and chronic kidney disease .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Diabetic patients without any macrovascular and microvascular Complications. |
| group 2 | – | –Diabetic patients with macrovascular (stroke, coronary heart disease, Peripheral artery disease) and microvascular (DN and DR) complications |
| group 3 | – | –Apparent healthy subjects as control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients who attending the Diabetes Clinic of Internal Medicine Department, Assiut University Hospital from January 2025 till January 2026.
Key inclusion criteria (3 listed)
- type 2 diabetic patients
- age more than 18 years old
- both sex
Key exclusion criteria (1 listed)
- Individuals with malignancies, pregnant women, those using furosemide, thiazide, acetylsalicylic acid, losartan group drugs, cholesterol lowering drugs, patients with other autoimmune disorders, patients with chronic kidney disease and gout.
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
uric acid / high density lipoprotein cholesterol ratio
Time frame: baseline
Calculation of UHR was calculated by dividing serum uric acid value by HDL-c value
monocyte / high density lipoprotein ratio
Time frame: baseline
calculated by dividing of count of monocyte by HDL-c level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Results publication: PubMed 38078589American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Assiut University.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mennat Allah Gamal Abdelnaser, resident doctor (+201157429995, menaagamal23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uric acid / high density lipoprotein cholesterol ratio (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754813, which also lists 1 linked publication.
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 1 Jan 2025.