Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy
- Conditions
- Peripheral Diabetic Neuropathy
- Interventions
- Drug: Super Oxide DismutaseDrug: Resveratrol, Alpha lipoic acid, Super oxide dismutase
- Registration Number
- NCT06131918
- Lead Sponsor
- Khyber Medical University Peshawar
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients with Type 2 Diabetes Mellitus
- Age between 40-60 years
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Superoxide dismutase Super Oxide Dismutase This group will receive Tab Superoxide dismutase 250mg BD Resveratrol+ Alpha lipoic acid +Superoxide dismutase Resveratrol, Alpha lipoic acid, Super oxide dismutase This group will receive Resveratrol 1500 mg BD Tab Alpha lipoic acid 600 mg BD Tab Superoxide dismutase 250 mg BD Resveratrol Resveratrol This group will receive Tab Resveratrol 1500 mg BD Alpha lipoic Acid Alpha lipoic acid This group will receive Tab Alpha lipoic acid 600mg BD
- Primary Outcome Measures
Name Time Method Change in nerve conduction latency, velocity and amplitude. 4 months This will be assessed by doing Nerve conduction studies at the start and end of trial. The nerves examined will be Median and Ulnar nerves in upper limb both for motor and sensory conduction. In case of lower limbs motor nerve Peroneal and sensory Sural nerve will be examined.
Change in clinical symptoms of neuropathy. 4 months 1. It will be assessed by Michigan neuropathy screening instrument at the start of the trial, at the end of each month and at the conclusion of the trial.
2. Changes in Quality of life will be assessed by Nottingham health profile.
3. Safety and tolerability of treatment. Recording and evaluation of adverse events and side effects will be done throughout the treatment period
- Secondary Outcome Measures
Name Time Method levels of superoxide radical anion, 4 months Change in the levels of superoxide radical anion
Levels of Malonaldehyde oxidative stress biomarker 4 months Change in the levels of oxidative stress biomarkers
Levels of Superoxide dismutase and Glutathione peroxidase 4 months Change in the levels of antioxidant enzymes
Trial Locations
- Locations (1)
Syed Hamid Habib
🇵🇰Peshawar, KPK, Pakistan