Clinical trial NCT06349850: Predictive Value of Serum Uric Acid to HDL Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
Official title: Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Kidney Injury
Keywords: DKI
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients
* willing and agreed to be included in the study

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Uric acid to HDL-c ratio (UHR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Eldeeb E. Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Koye 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.
citation: Saeedi 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.
citation: National 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.