Peripheral Diabetic Neuropathy
Conditions
Keywords
Diabetic Neuropathy, Resveratrol, Alpha lipoic acid, Superoxide dismutase
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.
Interventions
DRUGResveratrol, Alpha lipoic acid, Super oxide dismutase
Tab Resveratrol 1500 mg BD Tab Alpha lipoic Acid 600 mg BD Tab Superoxide dismutase 250 mg BD
DRUGResveratrol
Tab Resveratrol 1500 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
DRUGAlpha lipoic acid
Tab Alpha lipoic acid 600 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
DRUGSuper Oxide Dismutase
Tab Super oxide dismutase 250 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD
Sponsors
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The participants will not be given information about the medication.
Intervention model description
Four parallel treatment arms will be included.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Outcome results
None listed