Relationship of Serum Zinc Level with Severity of Diabetic Nephropathy

Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production.

However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney disease. this study aim to detect serum zinc level in patient with Diabetic kidney disease "CKD" and Study of association between serum zinc and serum urea, creatinine, GFR, hemoglobin ,HbA1c in DKD

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Nephropathy Type 2

Detailed Description

Chronic kidney disease (CKD) is an irreversible , progressive disease with high morbidity and mortality that occurs commonly in the general adult population, especially in people with diabetes and hypertension . It's defined as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause .

Diabetic kidney disease represents the most common cause of CKD in developed countries. Approximately 30% to 40% of diabetes mellitus (DM) subjects develop Diabetic kidney disease "DKD", and its presence significantly increases the risk for morbidity and mortality.

Zinc is an essential element and is the second most abundant divalent cation in the human body (2-4 g). It is mainly distributed in skeletal muscles (57%) and bone (29%) and acts as a cofactor for more than 300 enzymes. In addition, zinc is involved in the cellular mechanisms of proliferation, maintenance of structural integrity, and in the systemic regulation of the immune system . Zinc seems to have a potential role in kidney and body homeostasis in diabetic individuals which include stabilization of insulin hexamers and pancreatic insulin storage and improved glycemic control. Decreased zinc levels can impair insulin function and glucose metabolism, potentially worsening diabetes control and increasing the risk of kidney damage. Zinc is important for maintaining endothelial cell integrity and function. Endothelial dysfunction is a hallmark of DKD, and decreased zinc levels can exacerbate vascular complications associated with diabetes. Lower serum zinc levels have been associated with increased proteinuria, a common symptom of DKD. Proteinuria indicates kidney damage and is a predictor of disease progression. Zinc is involved in modulating the immune response. Deficiency can lead to a heightened inflammatory state, exacerbating kidney damage. Several studies underline the critical role of zinc in reducing oxidative stress levels, which is considered the common denominator of the mechanisms responsible for the progression of kidney disease. Zinc is a cofactor for various enzymes involved in heme synthesis and erythropoiesis

• Study Type: Observational
• Enrollment (Estimated): 92

Contacts and Locations

• Study Contact: Name: Salma Mohamed Sayed, resident doctors; Phone Number: +2 01060342916; Email: salma.16266351@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with diabetic kidney disease and Diabetic patient without kidney disease as a control

Description

Inclusion Criteria:

• Patients with diabetic kidney disease

Exclusion Criteria:

• patients on dialysis. Patient refuse to participate
• Other renal disease "lupus nephritis,GlomeruloNephritis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group 1; Patient with Diabetic kidney disease according to KDIG
group 2; patients with diabetes without chronic kidney disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
zinc level	prevalence of hypozincemia in Diabetic kidney disease	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Takao T, Yanagisawa H, Suka M, Yoshida Y, Onishi Y, Tahara T, Kikuchi T, Kushiyama A, Anai M, Takahashi K, Wakabayashi Sugawa S, Yamazaki H, Kawazu S, Iwamoto Y, Noda M, Kasuga M. Synergistic association of the copper/zinc ratio under inflammatory conditions with diabetic kidney disease in patients with type 2 diabetes: The Asahi Diabetes Complications Study. J Diabetes Investig. 2022 Feb;13(2):299-307. doi: 10.1111/jdi.13659. Epub 2021 Oct 7.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: serum zinc level
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Diabetes Mellitus; Diabetes Complications; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: Zinc and diabetic nephropathy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No