Aim: To investigate the effect of normalizing vitamin B12 (B12) levels with oral B12 (methylcobalamin) 1000 μg/day for one year in patients with diabetic neuropathy (DN). Patients and methods: In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively). We also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score). Results: B12 levels increased from 232.0 ± 71.8 at baseline to 776.7 ± 242.3 pmol/L at follow-up, p < 0.0001, in the active group but not in the control group. VPT, MNSIQ, QoL, pain score, SNCV, SNAP, and ESCF significantly improved in the active group (p < 0.001, p = 0.002, p < 0.0001, p < 0.000, p < 0.0001, p < 0.0001, and p = 0.014, respectively), whereas CARTS and MNSIE improved but not significantly. MCR, MNSIQ, SNCV, SNAP, and pain score significantly deteriorated in the control group (p = 0.025, p = 0.017, p = 0.045, p < 0.0001, and p < 0.0001, respectively). Conclusions: The treatment of patients with DN with 1 mg of oral methylcobalamin for twelve months increased plasma B12 levels and improved all neurophysiological parameters, sudomotor function, pain score, and QoL, but it did not improve CARTS and MNSIE.

Aim: To investigate the efficacy of Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12) in one tablet in Diabetic Neuropathy (DN). Patients–methods: In this prospective, double-blind, placebo-controlled study, 85 patients with Diabetes Mellitus Type 2 (DMT2) were randomly assigned, either to receive the combination of four elements (active group, n = 43), or placebo (n = 42) for 12 months. We used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured the vibration perception threshold (BIO), and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Pain (PS) and quality of life (QL) questionnaires were administered. Results: At follow-up, BIO, MNSIQ, QL, PAIN, and SNCV, SNAP, and B12 levels had significantly improved inactive group (p <0.001, p <0.001, p <0.001, p <0.001, p = 0.027, p = 0.031, and p <0.001 respectively), whereas the inplacebo group MCR (mean circular resultant) and PAIN deteriorated (p <0.001, p <0.001). The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups (p <0.001, p <0.001, p = 0.031, p <0.001, and p <0.001 respectively). Conclusions: The combination of the four elements in one tablet for 12 months in patients with DMT2 improved all indices of peripheral neuropathy, including SNAP and SNCV, pain, and Quality of Life perception, except CARTs and MNSIE.

Background: Experimental studies demonstrated a positive effect of administration of Crocus sativus L. (saffron) and its bioactive ingredients on metabolic profile through their antioxidant capacity. Purpose: To determine if the use of saffron in humans is beneficial to patients with diabetes mellitus (DM) or metabolic syndrome (MS). Methods: This systematic review includes 14 randomized control trials that investigated the impact of saffron administration and its bioactive ingredient crocin on the metabolic profile of patients with DM, MS, prediabetes, and coronary artery disease. We documented the following clinical outcomes: fasting blood glucose (FBG), glycated haemoglobin (HbA1c), total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, systolic, and diastolic blood pressure. Results: Eight studies examined the efficacy of saffron in patients with DM, four with the metabolic syndrome, one with prediabetes and one with coronary artery disease. A favorable effect on FBG was observed. The results regarding blood lipids and blood pressure were inconclusive in the current review. Conclusions: According to the available limited evidence, saffron may have a favorable effect on FBG. Many of the studies in the reviewed literature are of poor quality, and more research is needed in this direction to confirm and establish the above findings.

Type 1 diabetes mellitus (T1DM) patients occasionally develop disordered eating behaviors, leading to insulin manipulation without medical consultation, targeting to achieve weight control. In clinical practice, the Diabetes Eating Problem Survey-Revised Version (DEPS-R) questionnaire has been used to evaluate eating disorders in T1DM patients. This study was conducted to validate the factor structure of the Greek version of DEPS-R using Confirmatory Factor Analysis (CFA), to investigate its reliability and convergent validity in Greek T1DM adults and to compare a single factor DEPS-R model with multiple factor models. Participants were 103 T1DM adults receiving insulin, who responded to DEPS-R. Their anthropometric, biochemical and clinical history data were evaluated. The sample presented good glycemic control and 30.1% scored above the established DEPS-R cut-off score for disturbed eating behavior. CFA results revealed that the data fit well to the factor models. The DEPS-R scale had good reliability and was positively linked to BMI, HbA1c, total daily dose and time in range. Model comparison supported the superiority of the 1-factor model, implying that Greek clinicians and practitioners might not have to consider individualized treatment based on various scores across different subscales but they can adopt a single DEPS-R score for an easy and efficient screening for disordered eating.