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Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy

ConditionsDiabetic Peripheral NeuropathyDiabetic NeuropathyDiabetic Peripheral Neuropathy in Type 2 Diabetic Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group 1: Melatonin groupActive comparator 1 intervention
Group B: Group 2: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Oxidative stress marker

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

Secondary outcomes

1

Concentration of Tumor necrosis factor alpha

Inflammatory marker

Time frame
Change from baseline Tumor necrosis factor alpha at 3 months
2

Michigan neuropathy screening instrument questionnaire (MNSI-Q)

A questionnaire of 15 yes or no questions, a score of 7 or more means more neuropathic symptoms

Time frame
At baseline and after 3 months
3

Toronto clinical scoring system (TCSS)

A scoring system used to assess symptoms, reflexes and signs, as score increases indicates more neuropathy.

Time frame
At baseline and after 3 months
4

Diabetic neuropathy score (DNS)

A score used to assess the major symptoms of DPN.

Time frame
At baseline and after 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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