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

November 12, 2023 updated by: Khyber Medical University Peshawar

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan
        • Syed Hamid Habib

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective improvement in Diabetic Neuropathy
Time Frame: 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.
four months
Objective improvement in Diabetic Neuropathy
Time Frame: 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.
Four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of superoxide radical anion,
Time Frame: 4 months
Change in the levels of superoxide radical anion
4 months
Levels of Malonaldehyde oxidative stress biomarker
Time Frame: Four months
Change in the levels of oxidative stress biomarkers
Four months
Levels of Superoxide dismutase and Glutathione peroxidase
Time Frame: 4 months
Change in the levels of antioxidant enzymes
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Medical University Peshawar

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

December 22, 2023

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAMIDHABIB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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