The Rate of Insulin use and Suboptimal Glycemic Control among Egyptian Patients with T2DM: Cohort Analysis of Eighth Wave of the International Diabetes Management Practices Study (IDMPS).

AIMS: The International Diabetes Management Practices Study (IDMPS) is an international annual survey aiming to study and characterize the current standards of care for managing DM in developing countries. BACKGROUND: In Egypt, DM represents a substantial burden on the healthcare system, with an estimated 10.9 million patients, ranking it 10th amongst countries with the highest prevalence of DM. Previous studies showed that to maintain safety and achieve treatment goals among diabetic patients, optimal insulin therapy should be selected individually based on the patient's needs. We reported the proportion of Egyptian T2DM patients on insulin therapy who participated in the eighth wave of the IDMPS. METHODS: The 2018 IDMPS wave consisted of cross-sectional and longitudinal phases and aimed to evaluate the proportion of T2DM who were on insulin therapy in 13 countries from four regions. In Egypt, 17 physicians agreed to participate in the present study and were required to include at least one patient. RESULTS: A total of 180 T2DM patients were included in the cross-section phase. At the end of the ninth month of follow-up, data from 170 T2DM patients were available. A total of 39 T2DM patients (21.7%) were on insulin therapy, with a mean duration of 32.4 ± 36.6 months. More than half of the patients (n = 22; 56.4%) were on basal insulin, mainly long-acting (n = 20; 90.9%). The mean basal insulin daily dose was 0.3 ± 0.1 IU/Kg. Notably, 28.2% of the patients received insulin via vials, and 46.2% stated that they were adjusting the insulin dose by themselves. On the other hand, 60.2% of the study population was on oral antidiabetic drugs at the cross-sectional phase. Nearly 17.4% and 27% of the patients in the cross-sectional phase achieved the glycemic target per recommendations of international guidelines and the treating physicians, respectively. At the end of the longitudinal phase, the percentage of T2DM patients who achieved glycemic targets increased to 38.4% and 77.4% as per recommendations of international guidelines and the treating physicians, respectively. Overall, 38.3% of T2DM patients received diabetes education, and 28.9% were involved in an educational program provided by the physician or their clinical staff. Besides, 85.5% of T2DM patients followed their diabetes medication dosage and frequency strictly as prescribed. CONCLUSION: The proportion of insulin use in patients with T2DM aligned with the previous studies from different countries; however, it is still inadequate to achieve the targeted glycemic control. Nearly one-third of Egyptian patients received diabetes education, highlighting the need for adopting a national educational program. Nonetheless, the level of adherence among T2DM from Egypt appears to be high.

A Phase II, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients Newly Diagnosed with Type 2 Diabetes Mellitus.

Background: Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, newly diagnosed T2DM patients. Methods: This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged ≥18 and ≤65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu® (content of four capsules per day), or high-dose NW Low-Glu® (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm. Results: There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p=0.002) and high-dose arms (0.8 (1.7)%; p=0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p=0.001) and high-dose arms (24.7 (100.8) mg/dL, p=0.04). Weight reduction was significantly higher with both high-dose (1.1 (-1.7) Kg; p=0.005) and low-dose arms (0.9 (-1.5) Kg; p=0.023) compared to metformin (0.8 (-1.8) Kg). No serious AEs or deaths were reported. Conclusions: After 3 months of treatment, NW Low-Glu® was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated.

Comparison of the percentages of CD4+ CD25high FOXP3+ , CD4+ CD25low FOXP3+ , and CD4+ FOXP3+ Tregs, in the umbilical cord blood of babies born to mothers with and without preeclampsia.

PROBLEM: Little is known about how preeclampsia affects regulatory T-cell count and functions in umbilical cord blood of babies born to preeclamptic mothers. Here, we analyze the percentage of CD4+  CD25high  FOXP3+ , CD4+  CD25low  FOXP3+ , and CD4+  FOXP3+ Tregs, in the umbilical cord blood of babies born to mothers with and without preeclampsia. METHOD OF STUDY: The percentage of umbilical cord blood CD4+  CD25high  FOXP3+ , CD4+  CD25low  FOXP3+ , and CD4+  FOXP3+ Tregs were analyzed by flow cytometry. RESULTS: CD4+  CD25high  FOXP3+ Treg (%) and CD4+  FOXP3+ Treg (%) were significantly lower, while CD4+  CD25low (%) was significantly higher in umbilical cord blood of babies born to preeclamptic mothers. CONCLUSION: Preeclampsia is associated with immune dysregulation which leads to a deficiency in Treg (CD4+  CD25high  FOXP3+ ) in the umbilical cord blood of babies born to preeclamptic mothers.

Detection of simian virus 40 DNA sequences in Egyptian patients with different hematological malignancies.

SV40 DNA sequences have been detected in non-Hodgkin's lymphoma patients. A link between SV40 and NHL is biologically plausible since SV40 causes hematological malignancies in laboratory rodents. We investigated 266 Egyptian cases of hematological malignancies (158 NHL, 54 HD, 26 ALL, 13 AML, 8 CLL, 7 CML) and 34 subjects as a control for detection of SV40 DNA using nested PCR. SV40 DNA sequences were found in (53.8%) of NHL, (29.6%) of HD and in (40.7%) of different types of leukemia cases. Frequency of SV40 DNA sequences was higher in NHL patients compared with those with the other tumors and control group (p < 0.05). The highest frequency was in Burkitt's lymphoma followed by diffuse large B-cell lymphoma. The present study suggests that SV40 is significantly associated with non-Hodgkin's lymphoma and most probably acts as a cofactor in the pathogenesis of these tumors. This could lead to new diagnostic, therapeutic, and preventive approaches.

Hepatitis B virus (HBV) genotypes in Egyptian pediatric cancer patients with acute and chronic active HBV infection.

BACKGROUND: There are eight genotypes of hepatitis B virus (A-H) and subgenotypes are recognized. Genotyping can be accomplished based on a partial sequence of HBV genome such as the pre-S or S gene. Several methods have been developed and used for HBV genotyping. This study was undertaken to determine the HBV genotypes in Egyptian pediatric cancer patients with acute and chronic liver disease. METHODS: HBV genotypes were determined in 22 patients who had acute forms of liver disease (AH) and in 48 patients with chronic active hepatitis (CAH). A type-specific primer based the nested-PCR method was employed in the HBV genotyping. RESULTS: This study showed that HBV infections in pediatric cancer patients are attributed predominantly to viral genotypes D and B that constituted 37.1% and 25.7%, respectively of the total infections. In addition, there was a relatively high prevalence of mixed infections of 15.7% among the studied group especially mixed A/D genotype infections. Genotype D was found significantly more often in patients with CAH than in patients with AH [23/48(47.9%) v 3/22 (13.6%)]. CONCLUSION: These findings show the distribution of HBV A-D genotypes in pediatric cancer Egyptian patients. Furthermore, our results indicate a markedly high prevalence of mixed A/D genotype infections in subjects with CAH and a possible association of mixed infections with the severity of liver diseases.

Genetic distance and heterogenecity between quasispecies is a critical predictor to IFN response in Egyptian patients with HCV genotype-4.

BACKGROUND: HCV is one of the major health problems in Egypt, where it is highly prevalent. Genotype 4 is the most common genotype of HCV and its response to treatment is still a controversy. METHODS: HCV genotype 4 quasispecies diversity within the 5' untranslated region (5'UTR) was studied in a series of 22 native Egyptian patients with chronic hepatitis C virus with no previous treatment who satisfied all NIH criteria for combined treatment of pegylated IFN and ribavirine and was correlated with the outcome of treatment. The study also included 7 control patients with no antiviral treatment. HCV sequencing was done using the TRUGENE HCV 5-NC genotyping kit. RESULTS: At the 48th week of treatment, 15 patients (68%) showed virological response. Whereas HCV-RNA was still detected in 7 patients (32%) in this period; of those, 6 experienced a partial virological response followed by viral breakthrough during treatment. Only one patient did not show any virological or chemical response. The four females included in this study were all responders. There was a significant correlation between the response rate and lower fibrosis (p = 0.026) as well as the total number of mutation spots (including all the insertions, deletions, transitions and transversions) (p = 0.007, p = 0.035). CONCLUSION: Patients who responded to interferon treatment had statistically significant less number in both transitions (p = 0.007) and the genetic distances between the quasispecies (p = 0.035). So, viral genetic complexity and variability may play a role in the response to IFN treatment. The consensus alignment of all three groups revealed no characteristic pattern among the three groups. However, the G to A transitions at 160 was observed among non responders who need further study to confirm this observation.