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

Khyber Medical University Peshawar

Status and phase: Completed; Phase 2

Conditions: Peripheral Diabetic Neuropathy

Treatments: Drug: Alpha lipoic acid; Drug: Resveratrol, Alpha lipoic acid, Super oxide dismutase; Drug: Resveratrol; Drug: Super Oxide Dismutase

Study type: Interventional

Funder types: Other

Identifiers

NCT06131918

HAMIDHABIB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Resveratrol+ Alpha lipoic acid +Superoxide dismutase

Active Comparator group

Description:

This group will receive Resveratrol 1500 mg BD Tab Alpha lipoic acid 600 mg BD Tab Superoxide dismutase 250 mg BD

Treatment:

Drug: Resveratrol, Alpha lipoic acid, Super oxide dismutase

Resveratrol

Active Comparator group

Description:

This group will receive Tab Resveratrol 1500 mg BD

Treatment:

Drug: Resveratrol

Alpha lipoic Acid

Active Comparator group

Description:

This group will receive Tab Alpha lipoic acid 600mg BD

Treatment:

Drug: Alpha lipoic acid

Superoxide dismutase

Active Comparator group

Description:

This group will receive Tab Superoxide dismutase 250mg BD

Treatment:

Drug: Super Oxide Dismutase