Role of Carnosine in Combination With Vitamin B Complex in Preventing the Progression of Diabetic Neuropathy in Type 2 Diabetes Patients
NCT ID: NCT05422352
Last Updated: 2022-06-29
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-01-14
2022-03-28
Brief Summary
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Detailed Description
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DPN is a group of clinical syndromes that affects single or combined regions in the nervous system and is considered one of the microvascular complications that affect greatly the quality of life of patients due to pain and frequency of hospitalization.
DPN commonly develops silent without symptoms in the early stages and when symptoms start appearing only a few effective therapies are available and that is what causes significant patient suffering and societal burden.
Those mechanisms of pain and treatment remain challenging and are restricted by variable efficacy and side effects of therapies and intensification of glycemic control remain the cornerstone for the prevention or delay of DPN.
Lately, it has been proven that long-term low-grade inflammation has an important role in DPN pathogenesis. Clinical trials in DPN patients with pain and without pain showed that the DPN with pain group had higher inflammation markers.
In addition, DPN patients with pain had more increased cytokine levels compared with DPN patients without pain. Besides the correlation between abnormalities in nerve fibers and the rise in interleukin (IL)-6 and IL-10.
Moreover, Oxidative stress plays an important role in the development of diabetic neuropathy a reactive oxygen species (ROS) increases the progression of nerve fiber damage and dysfunction.
Those reactive oxygen species are capable of destroying the lipids found in the myelinated structures of nerves resulting in axon loss and disturbance in the microvasculature of the peripheral nervous system.
Antioxidants are available endogenously as a normal defense mechanism of the cell or obtained exogenously from diet and could play an important role in the progression of damage to the neurons in Diabetic neuropathy.
Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and innervated muscle) of vertebrates.
Carnosine is claimed to decrease oxygen-free-radical mediated damage to cellular macromolecules either by chelating divalent cations or scavenging hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to affects the structure of proteins and nucleic acids.
Furthermore, previous studies proved the neuroprotective action of carnosine with its anti-inflammatory and antioxidant properties.
Moreover, another study highlighted the use of carnosine as a supportive treatment against neurotoxins.
Also, Carnosine has been shown to protect cultured neurons from oxygen-glucose deprivation and to exhibit neuroprotective properties in animal models of global and cerebral ischemia
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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intervention Group
Patients who will receive carnosine supplementation + Vitamin B complex two tablets per day
Carnosine
Patients who will receive carnosine supplementation 500mg capsules (Now foods) in combination with Vitamin B complex (B1+B6+B12, 150 mg+100 mg+1 mg, respectively, Neurovit, European Egyptian Pharm. Ind., Egypt), two tablets per day
Control group
Patients will receive only Vitamin B Complex two tablets per day
No interventions assigned to this group
Interventions
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Carnosine
Patients who will receive carnosine supplementation 500mg capsules (Now foods) in combination with Vitamin B complex (B1+B6+B12, 150 mg+100 mg+1 mg, respectively, Neurovit, European Egyptian Pharm. Ind., Egypt), two tablets per day
Eligibility Criteria
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Inclusion Criteria
* Patients were showing clinical signs of Diabetic neuropathy verified by a neurologist and confirmed by a score ≥7 on the MNSI questionnaire (Michigan Neuropathy Screening Instrument), with abnormal nerve conduction measurement.
* Patients on a regular visit to the clinic.
Exclusion Criteria
* Patients with a BMI of 40 kg/m2 or more and those pregnant or breastfeeding were also excluded
20 Years
100 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
Responsible Party
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Mahitab Hany Ahmed
Principle investigator (Assistant lecturer of clinical pharmacy department )
Principal Investigators
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H F Salem, Professor
Role: STUDY_CHAIR
Beni-Suef University
Locations
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Beni Suef University faculty of pharmacy
Banī Suwayf, Beni Suweif Governorate, Egypt
Countries
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References
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Hipkiss AR. Glycation, ageing and carnosine: are carnivorous diets beneficial? Mech Ageing Dev. 2005 Oct;126(10):1034-9. doi: 10.1016/j.mad.2005.05.002.
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.
Edwards JL, Vincent AM, Cheng HT, Feldman EL. Diabetic neuropathy: mechanisms to management. Pharmacol Ther. 2008 Oct;120(1):1-34. doi: 10.1016/j.pharmthera.2008.05.005. Epub 2008 Jun 13.
Tesfaye S, Selvarajah D. Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:8-14. doi: 10.1002/dmrr.2239.
Vinik A I, "Diabetic Neuropathies," Contemp. Endocrinol. Controv. Treat. Diabetes Clin. Res. Asp.(2000), 109-134.
Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
Shakher J, Stevens MJ. Update on the management of diabetic polyneuropathies. Diabetes Metab Syndr Obes. 2011;4:289-305. doi: 10.2147/DMSO.S11324. Epub 2011 Jul 21.
Jin HY, Park TS. Role of inflammatory biomarkers in diabetic peripheral neuropathy. J Diabetes Investig. 2018 Sep;9(5):1016-1018. doi: 10.1111/jdi.12794. Epub 2018 Jan 22.
Doupis J, Lyons TE, Wu S, Gnardellis C, Dinh T, Veves A. Microvascular reactivity and inflammatory cytokines in painful and painless peripheral diabetic neuropathy. J Clin Endocrinol Metab. 2009 Jun;94(6):2157-63. doi: 10.1210/jc.2008-2385. Epub 2009 Mar 10.
Hipkiss AR, Michaelis J, Syrris P. Non-enzymatic glycosylation of the dipeptide L-carnosine, a potential anti-protein-cross-linking agent. FEBS Lett. 1995 Aug 28;371(1):81-5. doi: 10.1016/0014-5793(95)00849-5.
Tsai SJ, Kuo WW, Liu WH, Yin MC. Antioxidative and anti-inflammatory protection from carnosine in the striatum of MPTP-treated mice. J Agric Food Chem. 2010 Nov 10;58(21):11510-6. doi: 10.1021/jf103258p. Epub 2010 Oct 6.
Other Identifiers
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Carnosine Diabetic neuropathy
Identifier Type: -
Identifier Source: org_study_id
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