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

NCT ID: NCT06131918

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2024-05-05

Brief Summary

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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

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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.

Conditions

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Peripheral Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Four parallel treatment arms will be included.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The participants will not be given information about the medication.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Resveratrol, Alpha lipoic acid, Super oxide dismutase

Intervention Type DRUG

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

Resveratrol

This group will receive Tab Resveratrol 1500 mg BD

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type DRUG

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

Alpha lipoic Acid

This group will receive Tab Alpha lipoic acid 600mg BD

Group Type ACTIVE_COMPARATOR

Alpha lipoic acid

Intervention Type DRUG

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

Superoxide dismutase

This group will receive Tab Superoxide dismutase 250mg BD

Group Type ACTIVE_COMPARATOR

Super Oxide Dismutase

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Resveratrol

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

Intervention Type DRUG

Alpha lipoic acid

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

Intervention Type DRUG

Super Oxide Dismutase

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

Intervention Type DRUG

Other Intervention Names

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Resveratrol Alpha lipoic Acid Superoxide dismutase Tab Resveratrol Tab Placebo Capsule Placebo Tab Placebo Cap Placebo Superoxide dismutase Tab Placebo Cap Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khyber Medical University Peshawar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Syed Hamid Habib, PhD

Role: STUDY_DIRECTOR

Khyber Medical University

Locations

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Syed Hamid Habib

Peshawar, KPK, Pakistan

Site Status

Countries

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Pakistan

References

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Jiang B, Guo L, Li BY, Zhen JH, Song J, Peng T, Yang XD, Hu Z, Gao HQ. Resveratrol attenuates early diabetic nephropathy by down-regulating glutathione s-transferases Mu in diabetic rats. J Med Food. 2013 Jun;16(6):481-6. doi: 10.1089/jmf.2012.2686.

Reference Type BACKGROUND
PMID: 23767859 (View on PubMed)

Bhatt JK, Thomas S, Nanjan MJ. Resveratrol supplementation improves glycemic control in type 2 diabetes mellitus. Nutr Res. 2012 Jul;32(7):537-41. doi: 10.1016/j.nutres.2012.06.003. Epub 2012 Jul 27.

Reference Type BACKGROUND
PMID: 22901562 (View on PubMed)

Kennedy DO, Wightman EL, Reay JL, Lietz G, Okello EJ, Wilde A, Haskell CF. Effects of resveratrol on cerebral blood flow variables and cognitive performance in humans: a double-blind, placebo-controlled, crossover investigation. Am J Clin Nutr. 2010 Jun;91(6):1590-7. doi: 10.3945/ajcn.2009.28641. Epub 2010 Mar 31.

Reference Type BACKGROUND
PMID: 20357044 (View on PubMed)

Szkudelski T, Szkudelska K. Resveratrol and diabetes: from animal to human studies. Biochim Biophys Acta. 2015 Jun;1852(6):1145-54. doi: 10.1016/j.bbadis.2014.10.013. Epub 2014 Oct 27.

Reference Type BACKGROUND
PMID: 25445538 (View on PubMed)

Bjornholm M, Zierath JR. Insulin signal transduction in human skeletal muscle: identifying the defects in Type II diabetes. Biochem Soc Trans. 2005 Apr;33(Pt 2):354-7. doi: 10.1042/BST0330354.

Reference Type BACKGROUND
PMID: 15787605 (View on PubMed)

Villegas-Rivera G, Roman-Pintos LM, Cardona-Munoz EG, Arias-Carvajal O, Rodriguez-Carrizalez AD, Troyo-Sanroman R, Pacheco-Moises FP, Moreno-Ulloa A, Miranda-Diaz AG. Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Oxid Med Cell Longev. 2015;2015:756294. doi: 10.1155/2015/756294. Epub 2015 Jul 28.

Reference Type BACKGROUND
PMID: 26290682 (View on PubMed)

Oyenihi AB, Ayeleso AO, Mukwevho E, Masola B. Antioxidant strategies in the management of diabetic neuropathy. Biomed Res Int. 2015;2015:515042. doi: 10.1155/2015/515042. Epub 2015 Mar 2.

Reference Type BACKGROUND
PMID: 25821809 (View on PubMed)

Kumar A, Kaundal RK, Iyer S, Sharma SS. Effects of resveratrol on nerve functions, oxidative stress and DNA fragmentation in experimental diabetic neuropathy. Life Sci. 2007 Mar 6;80(13):1236-44. doi: 10.1016/j.lfs.2006.12.036. Epub 2007 Jan 20.

Reference Type BACKGROUND
PMID: 17289084 (View on PubMed)

Xiao WH, Bennett GJ. Effects of mitochondrial poisons on the neuropathic pain produced by the chemotherapeutic agents, paclitaxel and oxaliplatin. Pain. 2012 Mar;153(3):704-709. doi: 10.1016/j.pain.2011.12.011. Epub 2012 Jan 13.

Reference Type BACKGROUND
PMID: 22244441 (View on PubMed)

Pham-Huy LA, He H, Pham-Huy C. Free radicals, antioxidants in disease and health. Int J Biomed Sci. 2008 Jun;4(2):89-96.

Reference Type BACKGROUND
PMID: 23675073 (View on PubMed)

Valko M, Leibfritz D, Moncol J, Cronin MT, Mazur M, Telser J. Free radicals and antioxidants in normal physiological functions and human disease. Int J Biochem Cell Biol. 2007;39(1):44-84. doi: 10.1016/j.biocel.2006.07.001. Epub 2006 Aug 4.

Reference Type BACKGROUND
PMID: 16978905 (View on PubMed)

Rahimi-Madiseh M, Malekpour-Tehrani A, Bahmani M, Rafieian-Kopaei M. The research and development on the antioxidants in prevention of diabetic complications. Asian Pac J Trop Med. 2016 Sep;9(9):825-831. doi: 10.1016/j.apjtm.2016.07.001. Epub 2016 Aug 5.

Reference Type BACKGROUND
PMID: 27633293 (View on PubMed)

Other Identifiers

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HAMIDHABIB

Identifier Type: -

Identifier Source: org_study_id

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