Diabetic Nephropathy, Folic Acid, Melatonin
Conditions
Brief summary
The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy.
Detailed description
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.
Interventions
DRUGConventional diabetic treatment
Patients in the control group will receive conventional diabetic treatment.
DRUGFolic acid
Patients who received receive normal therapy augmented with folic acid (400 µg/day).
DRUGMelatonin
Patients who receive standard therapy supplemented with melatonin (3 mg/day).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the urine albumin-to-creatinine ratio (UACR) | 12-week after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the estimated glomerular filtration rate (eGFR) | 12-week after treatment | 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. |
| Change in the serum creatinine | 12-week after treatment | 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. |
| Change in the neutrophil gelatinase-associated lipocalin (NGAL) | 12-week after treatment | 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). |
Countries
Egypt
Outcome results
None listed