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

Sponsor
Khyber Medical University Peshawar (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06131918
Collaborator
(none)
100
1
4
13.4
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Resveratrol, Alpha lipoic acid, Super oxide dismutase
  • Drug: Resveratrol
  • Drug: Alpha lipoic acid
  • Drug: Super Oxide Dismutase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Four parallel treatment arms will be included.Four parallel treatment arms will be included.
Masking:
Single (Participant)
Masking Description:
The participants will not be given information about the medication.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Dec 22, 2023
Anticipated Study Completion Date :
Feb 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Resveratrol+ Alpha lipoic acid +Superoxide dismutase

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

Drug: Resveratrol, Alpha lipoic acid, Super oxide dismutase
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
  • Active Comparator: Resveratrol

    This group will receive Tab Resveratrol 1500 mg BD

    Drug: Resveratrol
    Tab Resveratrol 1500 mg BD

    Active Comparator: Alpha lipoic Acid

    This group will receive Tab Alpha lipoic acid 600mg BD

    Drug: Alpha lipoic acid
    Tab Alpha lipoic acid 600 mg BD

    Active Comparator: Superoxide dismutase

    This group will receive Tab Superoxide dismutase 250mg BD

    Drug: Super Oxide Dismutase
    Tab Super oxide dismutase 250 mg BD
    Other Names:
  • Superoxide dismutase
  • Outcome Measures

    Primary Outcome Measures

    1. Subjective improvement in Diabetic Neuropathy [four months]

      Subjective improvement in Diabetic neuropathy will be assessed by Michigan Neuropathy Screening Instrument (MNSI). It consists of a patient version which is a questionnaire that will be filled by the patient. These questions will assess the symptoms of neuropathy on a scale of 0-13 points. A score of 4 or greater than 4 indicates neuropathy. It also consists of a physical assessment form which will be completed by the health professional. The physical assessment has a scoring of 0-10 points. In physical assessment appearance of the feet is checked for any deformity, dryness ulceration. Ankle reflex, vibration perception at great toe and monofilament test is also performed. Decrease in scoring will show improvement in neuropathy which means a score equal to or greater than 4 indicates neuropathy and less than 4 indicates no neuropathy or improvement in neuropathy.

    2. Objective improvement in Diabetic Neuropathy [Four months]

      Nerve conduction studies (NCS) which is the gold standard for diagnosis of neuropathy will be performed. Latency in (milliseconds), amplitude in (millivolts) and nerve conduction velocity in (meters/second) will be measured. Among sensory nerve median and ulnar in the hand will be examined and sural nerve in the foot. Among motor nerves in the hand median and ulnar will be examined and in the foot peroneal and tibial will be examined. A decrease in latency and an increase in amplitude and nerve conduction velocity will show improvement.

    Secondary Outcome Measures

    1. levels of superoxide radical anion, [4 months]

      Change in the levels of superoxide radical anion

    2. Levels of Malonaldehyde oxidative stress biomarker [Four months]

      Change in the levels of oxidative stress biomarkers

    3. Levels of Superoxide dismutase and Glutathione peroxidase [4 months]

      Change in the levels of antioxidant enzymes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Syed Hamid Habib Peshawar KPK Pakistan

    Sponsors and Collaborators

    • Khyber Medical University Peshawar

    Investigators

    • Study Director: Syed Hamid Habib, PhD, Khyber Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Khyber Medical University Peshawar
    ClinicalTrials.gov Identifier:
    NCT06131918
    Other Study ID Numbers:
    • HAMIDHABIB
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Khyber Medical University Peshawar
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023