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The effect of melatonin and atorvastatin on diabetic nephropathy

Evaluating the effect of co-administration of melatonin and atorvastatin in type II diabetic patients with microalbuminuria

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181118041689N1
Enrollment
120
Registered
2018-11-24
Start date
2020-01-21
Completion date
Unknown
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus with kidney complication. Type 2 diabetes mellitus with kidney complications

Interventions

Intervention 1: Control group: Patients with type II diabetes who have microalbuminuria and receive atorvastatin (20 mg) and placebo once a day for 6 months. Intervention 2: Intervention group: Patien

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with type II diabetes Diabetic patient over 40 years of age. Patients with microalbuminuria (urinary albumin 30- 300 mg/24h) Patients who sign a written informed consent form. Patients with HbA1c of < 8%

Exclusion criteria

Exclusion criteria: Patients with blood pressure > 160 / 90 mmHg Patients with statins intolerance. Patients with statin-inducedmyopathy Patients who have used immunosuppressive drugs within 3 months of the first screening visit. Patients with intolerance to blood pressure reducing drugs (e.g., angiotensin II receptor-blocking drugs) Patients with other illness likely to influence the trial such as congestive heart failure, hypothyroidism, severe kidney failure, polycystic kidney disease, HIV nephropathy, ischemic kidney disease, interstitial nephritis of idiopathic kidney and hepatic failure Patients who have been kidney transplant in the past. Patients who have taken part in other clinical trials in the last 3 months. Patients who are pregnant or breast-feeding. Patients who are researchers and co-workers in this trial. Patients with a history of alcohol abuse or smoking.

Design outcomes

Secondary

MeasureTime frame
Glomerular filtration rate (GFR). Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: The measurement is based on the results of blood creatinine, urine creatinine and 24-hour urine volume.;Serum creatinine. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.;Blood triglyceride level. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.;Blood level of HDL cholesterol. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.;Blood level of LDL cholesterol. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.;Blood level of total cholesterol. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.;The level of fasting blood glucose. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.;The level of Blood Urea Nitrogen (BUN). Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Using biochemical tests.

Primary

MeasureTime frame
Urine albumin to creatinine ratio. Timepoint: Before the start of intervention and at 6 months after the start of treatment. Method of measurement: Measuring creatinine and albumin levels in urine using biochemical tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzam Hosseinzadeh

Iran University of Medical Sciences

azam.hosseinzade@yahoo.com+98 21 8670 3134

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026