Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes

March 31, 2024 updated by: Eldeeb Elsayed Mohamed, Sohag University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ali Taha Ali, Professor
  • Phone Number: 01005871047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HbA1c level group
  • well controlled diabetic group : HBA1c less than 7%
  • poorly controlled diabetic group : HBA1c equal to ore more than 7%
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
UHR level group

median levels of UHR will be used to dichotomize the patients into groups of :

  • low UHR group
  • high UHR group
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
DKI group

study population will be grouped into another two groups according to the presence of DKI:

  • patients with DKI
  • patients without DKI
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uric acid to HDL-c ratio (UHR)
Time Frame: 6 months
asociation of high UHR with development of DKI in type 2 DM
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-03-06MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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