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Completed

NCT Number: NCT06131918

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Syed Hamid Habib

Peshawar, KPK, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol, Alpha lipoic acid, Super oxide dismutase

Drug

Tab Resveratrol 1500 mg BD Tab Alpha lipoic Acid 600 mg BD Tab Superoxide dismutase 250 mg BD

Other names: Resveratrol, Alpha lipoic Acid, Superoxide dismutase

Resveratrol

Drug

Tab Resveratrol 1500 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD

Other names: Tab Resveratrol, Tab Placebo, Capsule Placebo

Alpha lipoic acid

Drug

Tab Alpha lipoic acid 600 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD

Other names: Tab Placebo, Cap Placebo

Super Oxide Dismutase

Drug

Tab Super oxide dismutase 250 mg BD Tab Placebo 600mg BD Cap Placebo 250mg BD

Other names: Superoxide dismutase, Tab Placebo, Cap Placebo

Primary outcomes

  1. Change in nerve conduction latency, velocity and amplitude.

    Time frame: 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.

  2. Change in clinical symptoms of neuropathy.

    Time frame: 4 months

    • 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.
    • Changes in Quality of life will be assessed by Nottingham health profile.
    • Safety and tolerability of treatment. Recording and evaluation of adverse events and side effects will be done throughout the treatment period

Secondary outcomes

  1. levels of superoxide radical anion,

    Time frame: 4 months

    Change in the levels of superoxide radical anion

  2. Levels of Malonaldehyde oxidative stress biomarker

    Time frame: 4 months

    Change in the levels of oxidative stress biomarkers

  3. Levels of Superoxide dismutase and Glutathione peroxidase

    Time frame: 4 months

    Change in the levels of antioxidant enzymes

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 14, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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