Role of Carnosine in Combination With Vitamin B Complex in Preventing the Progression of Diabetic Neuropathy in Type 2 Diabetes Patients

NCT05422352 | Completed DMC

• 1 other identifier: Carnosine Diabetic neuropathy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the influence of oral administration of carnosine in combination with vitamin B Complex in preventing the progression of diabetic neuropathy in type 2 diabetes patients.

Conditions

Diabetic Neuropathies

Keywords

Carnosine; diabetic neuropathy; oxidative stress; inflammation; Nerve conduction; type 2 diabetes; hyperglycemia; neopterin; nerve growth factor

Outcome Measures

Primary Outcomes (4)

• Neopterin biomarker

  Neopterin, a marker of inflammation and cellular immune response, is elevated in conditions of T-cell or macrophages activation. Diabetic peripheral neuropathy (DPN) is associated with inflammatory/immune processes therefore Investigators hypothesized that it will decrease after intervention

  3 months

• malondialdehyde biomarker

  it is oxidative stress marker that increases in the lipid peroxidation and inflammation happening during diabetic neuropathy and investigators hypothesized that it will decrease after intervention

  3 months

• Nerve Growth Factor

  a neurotrophic factor and neuropeptide primarily involved in the regulation of growth, maintenance, proliferation, and survival of certain target neurons and investigathypothesized its increase after intervention

  3 months

• Nerve Growth Factor

  a neurotrophic factor and neuropeptide primarily involved in the regulation of growth, maintenance, proliferation, and survival of certain target neurons and investigators hypothesized its increase after intervention

  3 months

Study Arms (2)

intervention Group

EXPERIMENTAL

Patients who will receive carnosine supplementation + Vitamin B complex two tablets per day

Dietary Supplement: Carnosine

Control group

NO INTERVENTION

Patients will receive only Vitamin B Complex two tablets per day

Interventions

Carnosine DIETARY_SUPPLEMENT

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

intervention Group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes Patients as per ADA 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.

You may not qualify if:

• Patients with neuropathy of non-diabetic origin were excluded.
• Patients with a BMI of 40 kg/m2 or more and those pregnant or breastfeeding were also excluded

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University faculty of pharmacy

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Related Publications (11)

• 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.

  PMID: 15955546 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 RESULT

• 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.

  PMID: 18616962 RESULT

• 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.

  PMID: 22271716 RESULT

• Vinik A I, "Diabetic Neuropathies," Contemp. Endocrinol. Controv. Treat. Diabetes Clin. Res. Asp.(2000), 109-134.

  RESULT

• 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.

  PMID: 22608666 RESULT

• 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.

  PMID: 21887102 RESULT

• 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.

  PMID: 29277966 RESULT

• 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.

  PMID: 19276232 RESULT

• 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.

  PMID: 7664889 RESULT

• 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.

  PMID: 20925384 RESULT

MeSH Terms

Conditions

Diabetic Neuropathies; Inflammation; Diabetes Mellitus, Type 2; Hyperglycemia; Hereditary Sensory and Autonomic Neuropathies

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• H F Salem, Professor

  Beni-Suef University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: intervention clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator (Assistant lecturer of clinical pharmacy department )

Model Details: intervention study clinical trial

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: January 14, 2021
• Primary Completion: January 30, 2022
• Study Completion: March 28, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)