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

Enrollment

Location

Arms

13.4

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

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
Peripheral Diabetic Neuropathy	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

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.
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

levels of superoxide radical anion, [4 months]
Change in the levels of superoxide radical anion
Levels of Malonaldehyde oxidative stress biomarker [Four months]
Change in the levels of oxidative stress biomarkers
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:

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.