Role of Carnosine in Combination With Vitamin B Complex in Preventing the Progression of Diabetic Neuropathy in Type 2 Diabetes Patients
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed description: 
      Diabetic peripheral neuropathy (DPN) is considered the most common chronic complication of
      diabetes mellitus, with an incidence rate of about 50%.

      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
    

Intervention name(s): Carnosine
Intervention type(s): Dietary Supplement
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention study clinical trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Carnosine; diabetic neuropathy; oxidative stress; inflammation; Nerve conduction; type 2 diabetes; hyperglycemia; neopterin; nerve growth factor