Actively Recruiting
Effect of Melatonin on Clinical Outcomes in Type 2 Diabetic Patients With Peripheral Neuropathy
Led by Ain Shams University · Updated on 2025-08-06
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of melatonin as an additional treatment on oxidative stress, inflammatory markers, and clinical outcomes in adults with type 2 diabetes who have diabetic peripheral neuropathy. This condition affects many patients and can cause symptoms like tingling and burning pain, often worsening at night. The study focuses on how melatonin may influence key biological pathways involved in nerve damage due to diabetes. This phase 2 trial is sponsored by Ain Shams University and aims to improve understanding of melatonin's impact on this condition. Participants will be randomly assigned to one of two groups: one group will receive 10 mg of melatonin daily before bedtime for 12 weeks alongside their usual diabetes treatment, while the other group will continue with their standard therapy without melatonin. The study will measure changes in oxidative and inflammatory markers, including Nrf2 and tumor necrosis factor-alpha, as well as clinical symptoms using validated questionnaires and scoring systems at the start and end of the 12-week period. Throughout the study, participants will undergo assessments including blood tests for oxidative and inflammatory markers and evaluations of neuropathy symptoms using tools like the Toronto Clinical Scoring System and the Michigan Neuropathy Screening Instrument Questionnaire. Samples collected will be stored for later analysis. The main outcome is the change in Nrf2 levels after three months. The total participation time is 12 weeks, during which safety and clinical progress will be closely monitored.
CONDITIONS
Brief Title
Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 to 75 years diagnosed with type 2 diabetes mellitus
- Diabetes duration of at least 1 year
- Diagnosis of diabetic peripheral neuropathy
- Stable antidiabetic medication for at least 1 month before and during the trial
You will not qualify if you...
- Autoimmune disorders such as lupus and rheumatoid arthritis
- Thyroid diseases
- Peripheral arterial disease
- Cancer
- Severe kidney or liver dysfunction
- Neurodegenerative diseases
- Active infection
- Use of medications or supplements that cause or treat peripheral neuropathy
- Alcohol consumption or substance abuse
- Use of antioxidant supplements or anti-inflammatory medicines during or 3 months before enrollment
- Pregnancy, lactation, or expecting to become pregnant during the study
- Allergy to melatonin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either melatonin in addition to standard therapy or standard therapy alone for diabetic peripheral neuropathy.
Visits at baseline and after 12 weeks for clinical assessments and lab tests
Trial Site Locations
Total: 1 location
1
Ain Shams University hospital
Cairo, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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