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Evaluation of the effects of melatonin supplementation in patients with type 2 diabetes

Evaluation of the effects of melatonin supplementation in patients with type 2 diabetes: a randomized: double-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230212057393N3
Enrollment
38
Registered
2024-05-17
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Diabetic nephropathy. Chapter IV Endocrine, nutritional and metabolic diseases(E00-E90)

Interventions

Intervention 1: The intervention group will include 30 patients with diabetic nephropathy with ACR greater than 30. 10 mg melatonin supplement made by Norm Life company will be received twice a day fo

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients with type 2 diabetes whose nephropathy was diagnosed through ACR test (>30 mg/gr) during a three-month period

Exclusion criteria

Exclusion criteria: Patients with heart failure Pregnant mothers Lactating mothers Sensitivity to melatonin and its analogues and simultaneous use of interfering drugs such as fluvoxamine,... Patients with urinary tract infections and uncontrolled blood pressure

Design outcomes

Primary

MeasureTime frame
Comparison of the nephroprotective effect of melatonin in patients with diabetic nephropathy. Timepoint: At the beginning of the study, before the intervention and at the end of the work after 3 months, ACR, serum creatinine and sugar of the patients are evaluated by a certain laboratory of the effect of oral melatonin drug. Method of measurement: The effect of melatonin drug on diabetic nephropathy patients is evaluated by using standard laboratory values and laboratory results.

Secondary

MeasureTime frame
Creatine-fasting blood sugar-glomerular filtration. Timepoint: 3 month. Method of measurement: laboratory test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahime Naderi

Mazandaran University of Medical Sciences

fahime.naderi90@gmail.com+98 11 5509 1101

Outcome results

None listed

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