Diabetic Kidney InjuryNCT06349850
Predictive Value of Serum Uric Acid to HDL Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
An observational study of Diabetic Kidney Injury, run by Sohag University.
Trial summary
An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Kidney Injury
- What is being tested?
- serum uric acid level to plasma HDL-c level ratio (UHR)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Sep 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: we will prospectively enroll patients from internal medicine department from march 2024 to august 2024 .all patients will be subjected to 1. Detailed medical history including : demographic characteristics,comorbid conditions,duration of diabetes mellitus,type of treatment and diabetic complications 2. Detailed clinical examination including : height , weight ,waist circumferenc,SBP,DBP,BMI 3. Fundus examination for retinopathy
Who may be able to join
- Type 2 diabetic patients
- willing and agreed to be included in the study
Who cannot join
- Type 1 DM patients
- patients with active urinary sediment
- patients with glomerulonephritis
- patients with diagnosis or clinical features that are suspicious for another systemic disease that commonly causes kidney disease
- patients with evidence of alternative kidney disease
- patients with history of kidney transplantation
Show all 15Show fewer
- patients with end stage renal disease
- patients with family history of non diabetic forms of kidney disease
- patients with active malignancy
- patients with established hemolytic disease
- CKD patients requiring dialysis
- patients taking drugs that interfere with serum uric acid level
- patients taking drugs that alter serum lipids level
- pregnancy
- Refused to consent to this study
Trial locations and contacts
No sites are listed yet.
Ali T. Ali, Professor contact
About this study
Official title: Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes
Read the detailed description
Diabetic Kidney Injury (DKI) is a serious microvascular complication of diabetes mellitus occuring in about 20 % to 50% of diabetic patients and is the single commonest cause of ESRD.DKI is asociated with arterial HTN and increased cardiovascular morbidity and mortality. outcomes for both type 1 DM and type 2 DM who develop DKI are significantly worse than who do not .Serum uric acid was reported to be asociated with inflamatory and metabolic diseases such as metabolic syndrome , type 2 DM,thyroiditis and NAFLD while HDL-cholesterol decreased the odds of developing DKI by 20%.It is generally accepted that hyperuricemia and low HDL-c were considered to be a risk factor of other indicators for development of DKI.
- Conditions
- Diabetic Kidney Injury
- Being tested
- serum uric acid level to plasma HDL-c level ratio (UHR)
- Keywords
- DKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum uric acid level to plasma HDL-c level ratio (UHR)Diagnostic test
high UHR is considered to be a risk factor for development of DKI in type 2 DM
| Study group | Role | What they receive |
|---|---|---|
| HbA1c level group | * well controlled diabetic group : HBA1c less than 7%
* poorly controlled diabetic group : HBA1c equal to ore more than 7% Receives: Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR) | |
| UHR level group | median levels of UHR will be used to dichotomize the patients into groups of :
* low UHR group
* high UHR group Receives: Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR) | |
| DKI group | study population will be grouped into another two groups according to the presence of DKI:
* patients with DKI
* patients without DKI Receives: Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric acid to HDL-c ratio (UHR)
asociation of high UHR with development of DKI in type 2 DM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Sohag 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 crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eldeeb Elsayed Mohamed, Sohag University
- Investigators
- Eldeeb E. Mohamed, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349850
- Sponsor's protocol ID
- Soh-Med-24-03-06MS
- Status last verified
- May 2024
- First submitted
- 31 Mar 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evans K, Pyart R, Steenkamp R, Whitlock T, Stannard C, Gair R, McCann J, Slevin J, Medcalf J, Caskey F. UK Renal Registry 20th Annual Report: Introduction. Nephron. 2018;139 Suppl 1:1-12. doi: 10.1159/000490958. Epub 2018 Jul 10. No abstract available.
PubMed 29990996Koye DN, Shaw JE, Reid CM, Atkins RC, Reutens AT, Magliano DJ. Incidence of chronic kidney disease among people with diabetes: a systematic review of observational studies. Diabet Med. 2017 Jul;34(7):887-901. doi: 10.1111/dme.13324. Epub 2017 Mar 9.
PubMed 28164387Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.
PubMed 23067652
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06349850
- Acronym / sponsor ID
- Soh-Med-24-03-06MS
- Conditions
- Diabetic Kidney Injury
- Keywords
- DKI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Apr 2024 (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.
An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes
Detailed description
Diabetic Kidney Injury (DKI) is a serious microvascular complication of diabetes mellitus occuring in about 20 % to 50% of diabetic patients and is the single commonest cause of ESRD.DKI is asociated with arterial HTN and increased cardiovascular morbidity and mortality. outcomes for both type 1 DM and type 2 DM who develop DKI are significantly worse than who do not .Serum uric acid was reported to be asociated with inflamatory and metabolic diseases such as metabolic syndrome , type 2 DM,thyroiditis and NAFLD while HDL-cholesterol decreased the odds of developing DKI by 20%.It is generally accepted that hyperuricemia and low HDL-c were considered to be a risk factor of other indicators for development of DKI.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HbA1c level group | – | Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR)* well controlled diabetic group : HBA1c less than 7% * poorly controlled diabetic group : HBA1c equal to ore more than 7% |
| UHR level group | – | Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR)median levels of UHR will be used to dichotomize the patients into groups of : * low UHR group * high UHR group |
| DKI group | – | Diagnostic Test: serum uric acid level to plasma HDL-c level ratio (UHR)study population will be grouped into another two groups according to the presence of DKI: * patients with DKI * patients without DKI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- we will prospectively enroll patients from internal medicine department from march 2024 to august 2024 .all patients will be subjected to 1. Detailed medical history including : demographic characteristics,comorbid conditions,duration of diabetes mellitus,type of treatment and diabetic complications 2. Detailed clinical examination including : height , weight ,waist circumferenc,SBP,DBP,BMI 3. Fundus examination for retinopathy
Key inclusion criteria (2 listed)
- Type 2 diabetic patients
- willing and agreed to be included in the study
Key exclusion criteria (15 listed)
- Type 1 DM patients
- patients with active urinary sediment
- patients with glomerulonephritis
- patients with diagnosis or clinical features that are suspicious for another systemic disease that commonly causes kidney disease
- patients with evidence of alternative kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum uric acid level to plasma HDL-c level ratio (UHR)high UHR is considered to be a risk factor for development of DKI in type 2 DM | Diagnostic test | DKI group, HbA1c level group, UHR level group |
Primary outcome
Uric acid to HDL-c ratio (UHR)
Time frame: 6 months
asociation of high UHR with development of DKI in type 2 DM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 29990996Evans K, Pyart R, Steenkamp R, Whitlock T, Stannard C, Gair R, McCann J, Slevin J, Medcalf J, Caskey F. UK Renal Registry 20th Annual Report: Introduction. Nephron. 2018;139 Suppl 1:1-12. doi: 10.1159/000490958. Epub 2018 Jul 10. No abstract available.
- Background: PubMed 28164387Koye DN, Shaw JE, Reid CM, Atkins RC, Reutens AT, Magliano DJ. Incidence of chronic kidney disease among people with diabetes: a systematic review of observational studies. Diabet Med. 2017 Jul;34(7):887-901. doi: 10.1111/dme.13324. Epub 2017 Mar 9.
- Background: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background: PubMed 23067652National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.
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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. This study is not recruiting at the moment.
Ali T. Ali, Professor contact
Eldeeb E. Mohamed principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Injury, run by Sohag 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eldeeb E. Mohamed, Resident (01092700322, deebbayern13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uric acid to HDL-c ratio (UHR) (time frame: 6 months). 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 NCT06349850, which also lists 4 linked publications.
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 16 May 2024.