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

NCT06131918 | Completed Phase 2

• 1 other identifier: HAMIDHABIB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Resveratrol; Alpha lipoic acid; Superoxide dismutase

Outcome Measures

Primary Outcomes (2)

• Change in nerve conduction latency, velocity and amplitude.

  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.

  4 months

• Change in clinical symptoms of neuropathy.

  1. 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. 2. Changes in Quality of life will be assessed by Nottingham health profile. 3. Safety and tolerability of treatment. Recording and evaluation of adverse events and side effects will be done throughout the treatment period

  4 months

Secondary Outcomes (3)

• levels of superoxide radical anion,

  4 months

• Levels of Malonaldehyde oxidative stress biomarker

  4 months

• Levels of Superoxide dismutase and Glutathione peroxidase

  4 months

Study Arms (4)

Resveratrol+ Alpha lipoic acid +Superoxide dismutase

ACTIVE COMPARATOR

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

Resveratrol

ACTIVE COMPARATOR

This group will receive Tab Resveratrol 1500 mg BD

Drug: Resveratrol

Alpha lipoic Acid

ACTIVE COMPARATOR

This group will receive Tab Alpha lipoic acid 600mg BD

Drug: Alpha lipoic acid

Superoxide dismutase

ACTIVE COMPARATOR

This group will receive Tab Superoxide dismutase 250mg BD

Drug: Super Oxide Dismutase

Interventions

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

Also known as: Resveratrol, Alpha lipoic Acid, Superoxide dismutase

Resveratrol+ Alpha lipoic acid +Superoxide dismutase

Resveratrol DRUG

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

Also known as: Tab Resveratrol, Tab Placebo, Capsule Placebo

Resveratrol

Alpha lipoic acid DRUG

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

Also known as: Tab Placebo, Cap Placebo

Alpha lipoic Acid

Super Oxide Dismutase DRUG

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

Also known as: Superoxide dismutase, Tab Placebo, Cap Placebo

Superoxide dismutase

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Type 2 Diabetes Mellitus
• Age between 40-60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Syed Hamid Habib

Peshawar, KPK, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 23767859 BACKGROUND

• 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.

  PMID: 22901562 BACKGROUND

• 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.

  PMID: 20357044 BACKGROUND

• 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.

  PMID: 25445538 BACKGROUND

• 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.

  PMID: 15787605 BACKGROUND

• 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.

  PMID: 26290682 BACKGROUND

• 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.

  PMID: 25821809 BACKGROUND

• 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.

  PMID: 17289084 BACKGROUND

• 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.

  PMID: 22244441 BACKGROUND

• 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.

  PMID: 23675073 BACKGROUND

• 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.

  PMID: 16978905 BACKGROUND

• 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.

  PMID: 27633293 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Resveratrol; Thioctic Acid; Superoxide Dismutase

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Oxidoreductases; Enzymes

Study Officials

• Syed Hamid Habib, PhD

  Khyber Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be given information about the medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four parallel treatment arms will be included.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: November 14, 2023
• Study Start: January 9, 2023
• Primary Completion: December 22, 2023
• Study Completion: May 5, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)