Efficacy of Melatonin in the Treatment of Diabetic Nephropathy Compared With Folic Acid

Tanta University75 enrolled

Overview

The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy.

Diabetes mellitus (DM) is a metabolic disorder characterized by chronic hyperglycemia, resulting from either insufficient insulin production (Type I) or ineffective insulin utilization (Type II). Melatonin, a hormone produced by the pineal gland, regulates circadian rhythms and exhibits strong antioxidant, anti-inflammatory, and immunomodulatory properties. Folic acid, a B-vitamin essential for cell division and DNA synthesis, also exerts antioxidant effects and supports endothelial function by lowering plasma homocysteine levels.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Melatonin Diabetic Nephropathy Folic Acid

Interventions

Conventional diabetic treatmentDRUG

Patients in the control group will receive conventional diabetic treatment.

Folic acidDRUG

Patients who received receive normal therapy augmented with folic acid (400 µg/day).

MelatoninDRUG

Patients who receive standard therapy supplemented with melatonin (3 mg/day).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18-75 years. * Patients with a confirmed diagnosis of Type 2 diabetes and diabetic nephropathy, as indicated by an elevated urine albumin-to-creatinine ratio (UACR ≥ 30 mg/g) or a decreased estimated glomerular filtration rate (eGFR \< 60 mL/min/1.73 m²). Exclusion Criteria: * Patients who are expectant or breastfeeding. * Have significant comorbidities. * Have rapidly declining renal function. * Have acute kidney injury.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

Change in the urine albumin-to-creatinine ratio (UACR)

Change in the urine albumin-to-creatinine ratio (UACR) will be recorded. The UACR is an important biomarker of kidney impairment because it measures the quantity of albumin discharged in the urine in relation to creatinine levels. Elevated UACR readings (≥ 30 mg/g) indicate albuminuria, a symptom of diabetic nephropathy.

Time frame: 12-week after treatment

Secondary Outcomes

Change in the estimated glomerular filtration rate (eGFR)

Change in the estimated glomerular filtration rate (eGFR) will be recorded. eGFR, which estimates the kidneys' filtering ability based on serum creatinine levels, age, sex, and race. A low eGFR (less than 60 mL/min/1.73 m²) may suggest chronic renal damage caused by diabetes.

Time frame: 12-week after treatment

Change in the serum creatinine

Change in the serum creatinine level will be recorded. Serum creatinine is a waste product produced by muscle metabolism, and excessive levels suggest poor kidney function, since the kidneys may struggle to filter waste properly.

Time frame: 12-week after treatment

Change in the neutrophil gelatinase-associated lipocalin (NGAL)

Change in the neutrophil gelatinase-associated lipocalin (NGAL) will be recorded. Neutrophil gelatinase-associated lipocalin is a protein produced by the kidneys in response to injury or damage, and increased levels are related with both acute kidney injury (AKI) and chronic kidney disease (CKD).

Time frame: 12-week after treatment

Data from ClinicalTrials.gov

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