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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06349850
Other study ID # Soh-Med-24-03-06MS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date September 2024

Study information

Verified date March 2024
Source Sohag University
Contact Eldeeb Elsayed Mohamed, Resident
Phone 01092700322
Email deebbayern13@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (4)

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. — View 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. — View 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. Erratum In: Am J Kidney Dis. 2013 Jun;61(6):1049. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Uric acid to HDL-c ratio (UHR) asociation of high UHR with development of DKI in type 2 DM 6 months
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