Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy

Study Overview
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Brief Summary
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Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. Screening of neuropathy will be done by Michigan screening instrument. This will be followed by nerve conduction studies. Specific blood parameters will also be checked. The subjects will then be divided into four treatment arms. Three groups will receive single drug and the fourth one will receive all the three drugs. These will be given for four months. Follow up will be done every month. At the end of four months, they will be assessed for any improvement in neuropathy by using Michigan neuropathy instrument and nerve conduction studies. Blood parameters will also be measured again.

Detailed Description
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Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. They will be screened by Michigan neuropathy scale. This is tool used for screening neuropathy. Subjects having a score equal to or greater then 4 will be examined for further evaluation. This will be followed by nerve conduction studies for objective assessment of neuropathy. For inclusion criteria the test performed will be HbA1c, CBC, ESR, RFTs and LFTs. After screening the baseline levels of Superoxide radical, Super oxide dismutase, Glutathione peroxidase and Malonaldehyde will be measured. The subjects will be randomly divided into four treatment arms. Group A will receive Triple regime antioxidant therapy including Resveratrol 1500 mg two times a day, Alpha lipoic acid 600 mg two times a day and Superoxide dismutase 250 mg once a day. Group B will receive Resveratrol 1500mg BD, Group C will be on Tab Alpha lipoic acid 600 mg BD and Group D will take Superoxide dismutase once a day. The subjects will be kept blinded about the medication. They will be followed every month in which their quality of life will be assessed using Nottingham health profile and neuropathy will be assessed by Michigan neuropathy scale. At the end of four months blood tests will again be performed to check the levels of Superoxide radical, Superoxide dismutase, Glutathione peroxidase and Malonaldehyde. NCS will be done to see any improvement in neuropathy.

Official Title
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Assessment of Resveratrol, Alpha Lipoic Acid and Superoxide Dismutase on Oxidative Stress Biomarkers in Type 2 Diabetes Mellitus Patients With Neuropathy: A Randomized Control Trial

Conditions
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Peripheral Diabetic Neuropathy

Intervention / Treatment
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* Drug: Resveratrol, Alpha lipoic acid, Super oxide dismutase
* Drug: Resveratrol
* Drug: Alpha lipoic acid
* Drug: Super Oxide Dismutase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 2 Diabetes Mellitus Age between 40-60 years Exclusion Criteria: Malignancy Vitamin B12 deficiency History of drug or alcohol abuse Taking antioxidant treatment History and baseline investigations for renal hepatic and haematological diseases Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Four parallel treatment arms will be included.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resveratrol+ Alpha lipoic acid +Superoxide dismutase<br>This group will receive Resveratrol 1500 mg BD Tab Alpha lipoic acid 600 mg BD Tab Superoxide dismutase 250 mg BD | Drug: Resveratrol, Alpha lipoic acid, Super oxide dismutase<br>* Tab Resveratrol 1500 mg BD Tab Alpha lipoic Acid 600 mg BD Tab Superoxide dismutase 250 mg BD<br>* Other names: Superoxide dismutase;|
| Active Comparator: Resveratrol<br>This group will receive Tab Resveratrol 1500 mg BD | Drug: Resveratrol<br>* Tab Resveratrol 1500 mg BD<br>|
| Active Comparator: Alpha lipoic Acid<br>This group will receive Tab Alpha lipoic acid 600mg BD | Drug: Alpha lipoic acid<br>* Tab Alpha lipoic acid 600 mg BD<br>|
| Active Comparator: Superoxide dismutase<br>This group will receive Tab Superoxide dismutase 250mg BD | Drug: Super Oxide Dismutase<br>* Tab Super oxide dismutase 250 mg BD<br>* Other names: Superoxide dismutase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective improvement in Diabetic Neuropathy | Subjective improvement in Diabetic neuropathy will be assessed by Michigan Neuropathy Screening Instrument (MNSI). It consists of a patient version which is a questionnaire that will be filled by the patient. These questions will assess the symptoms of neuropathy on a scale of 0-13 points. A score of 4 or greater than 4 indicates neuropathy. It also consists of a physical assessment form which will be completed by the health professional. The physical assessment has a scoring of 0-10 points. In physical assessment appearance of the feet is checked for any deformity, dryness ulceration. Ankle reflex, vibration perception at great toe and monofilament test is also performed. Decrease in scoring will show improvement in neuropathy which means a score equal to or greater than 4 indicates neuropathy and less than 4 indicates no neuropathy or improvement in neuropathy. | four months | 
| Objective improvement in Diabetic Neuropathy | Nerve conduction studies (NCS) which is the gold standard for diagnosis of neuropathy will be performed. Latency in (milliseconds), amplitude in (millivolts) and nerve conduction velocity in (meters/second) will be measured. Among sensory nerve median and ulnar in the hand will be examined and sural nerve in the foot. Among motor nerves in the hand median and ulnar will be examined and in the foot peroneal and tibial will be examined. A decrease in latency and an increase in amplitude and nerve conduction velocity will show improvement. | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of superoxide radical anion, | Change in the levels of superoxide radical anion | 4 months | 
| Levels of Malonaldehyde oxidative stress biomarker | Change in the levels of oxidative stress biomarkers | Four months | 
| Levels of Superoxide dismutase and Glutathione peroxidase | Change in the levels of antioxidant enzymes | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Neuropathy, Resveratrol, Alpha lipoic acid, Superoxide dismutase