Clinical trial NCT06131918: Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Diabetic Neuropathy
Keywords: Diabetic Neuropathy
Resveratrol
Alpha lipoic acid
Superoxide dismutase
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four parallel treatment arms will be included.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in nerve conduction latency, velocity and amplitude.
timeFrame: 4 months
measure: Change in clinical symptoms of neuropathy.
timeFrame: 4 months
Secondary outcomes:
measure: levels of superoxide radical anion,
timeFrame: 4 months
measure: Levels of Malonaldehyde oxidative stress biomarker
timeFrame: 4 months
measure: Levels of Superoxide dismutase and Glutathione peroxidase
timeFrame: 4 months
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Syed Hamid Habib
state: KPK
Study officials:
affiliation: Khyber Medical University
name: Syed Hamid Habib, PhD
role: STUDY_DIRECTOR
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