Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy

NCT07036796 | Recruiting Phase 2

• 1 other identifier: RHDIRB2020110301 REC#310
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to measure the effect of melatonin as adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in type 2 diabetic patients with diabetic peripheral neuropathy.

Conditions

Diabetic Peripheral Neuropathy; Diabetic Neuropathy; Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients

Keywords

Diabetic peripheral neuropathy; Diabetic neuropathies; Diabetic neuropathy in type 2 diabetes; Melatonin

Outcome Measures

Primary Outcomes (1)

• Concentration of human nuclear factor erythroid 2-related factor (Nrf2)

  Oxidative stress marker

  Change from baseline human Nuclear factor erythroid 2-related factor at 3 months.

Secondary Outcomes (5)

• Concentration of Tumor necrosis factor alpha

  Change from baseline Tumor necrosis factor alpha at 3 months

• Michigan neuropathy screening instrument questionnaire (MNSI-Q)

  At baseline and after 3 months

• Toronto clinical scoring system (TCSS)

  At baseline and after 3 months

• Diabetic neuropathy score (DNS)

  At baseline and after 3 months

• D-39 questionnaire

  At baseline and after 3 months.

Study Arms (2)

Group 1: Melatonin group

ACTIVE COMPARATOR

Group 1: Melatonin group (n=30) Patients will receive 10 mg (2 5mg Capsules) 1 hour before bedtime for 12 weeks, in addition to the standard therapy.

Drug: Melatonin

Group 2: control group

NO INTERVENTION

Group 2: No intervention, (n=30) patients will receive only standard therapy for 12 weeks

Interventions

Melatonin DRUG

Melatonin (N-acetyl-5-methoxytryptamine), also called the hormone of darkness, secreted primarily by the pineal gland. Possesses antioxidant, anti-inflammatory, anti-diabetic and neuroprotective effects. All of which could be explained by its activation of Nrf2 signaling pathway. Melatonin administration has shown to improve motor nerve conduction velocity and nerve blood flow, reduce the levels of pro-inflammatory cytokines, reinforce antioxidant defense, and decrease DNA fragmentation through upregulating nrf2 pathway, when tested in mice with diabetic peripheral neuropathy. Moreover, early treatment with melatonin has shown to prevent developing diabetic neuropathy in streptozotocin induced diabetic mice.

Group 1: Melatonin group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40-75 years diagnosed with type 2 DM.
• Diabetes duration at least 1 year.
• Patients diagnosed with diabetic peripheral neuropathy.
• Stable antidiabetic medication for at least 1 month before enrollment and during the trial

You may not qualify if:

• Patients with autoimmune disorders (such as lupus and rheumatoid arthritis), thyroid diseases, peripheral arterial disease and cancer patients.
• Patients with severe kidney or liver dysfunction.
• Patients diagnosed with neurodegenerative diseases.
• Active infection.
• Use of medications or supplements known to cause or treat peripheral neuropathy.
• Alcohol consumption or substance abuse.
• Patients consuming any antioxidant supplements or anti-inflammatory medicines during or 3 months before enrollment.
• Pregnancy or lactation or expecting to get pregnant during the study.
• Allergy to melatonin.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at Ain shams university

Model Details: Prospective Randomized controlled clinical trial open label

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): July 4, 2026
• Study Completion (Estimated): July 4, 2026
• Last Updated: August 6, 2025

Record last verified: 2024-12

Locations

EG (1)