MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.
METHOD: The NIH 3T3 and RAW 264.7 co-culture were induced with LPS and high glucose before it was treated with metformin in different concentration. After 24 hours of treatment, the media and the cells were collected for further examination. The collagen expression was measured using Sirius red dye in the media. The IL-6 and TGF β mRNA examination were done using real-time PCR.
RESULT: Our study showed that NIH 3T3 and RAW 264.7 coculture treated with metformin has higher collagen expression, but lower IL-6 mRNA expression compares to those on co-culture without treatment.
CONCLUSION: Metformin increases fibrosis markers in LPS and high glucose-induced NIH 3T3 and RAW 264.7 coculture despite its ability to improve IL-6 mRNA expression.
METHODOLOGY: A cross-sectional study was conducted among 269 older persons with diabetes in all government health clinics in Kuantan using Diabetes Quality of Life questionnaire. SPSS version 23 was used for the statistical analysis.
RESULTS: Majority of the respondents were females (61%), Malays (84.8%), pensioners (54.3%) with education up to primary school (52%) and are staying with family members (93.7%). Most of the patients were on two antidiabetic agents (48%) followed by a single antidiabetic agent (32%). Despite the risk of hypoglycaemia, 0.4% of them are on glibenclamide. The use of insulin is still common among 21% of them that are on intermediate-acting insulin, 15.6% on premixed insulin and 7.8% on short-acting insulin. Those taking a higher number of antidiabetic agents were found to be associated with poorer quality of life (p=0.001) compared to those taking one or two antidiabetic medications. Those on insulin also have significantly poorer quality of life score (p=0.012).
CONCLUSION: Despite aiming for controlled diabetes, older persons suffer poor quality of life with further intensification of their antidiabetic medications according to the guidelines. This includes the complexity of insulin usage and polypharmacy, which contribute to the low quality of life score.
METHODS: A comprehensive systematic search was carried out in PubMed/MEDLINE, Web of Science, SCOPUS and Embase from inception until June 2019. Weighted mean difference (WMD) with the 95 % CI were applied for estimating the effects of metformin on serum IGF-1 levels.
RESULTS: 11 studies involving a total of 569 individuals reported changes in IGF-1 plasma concentrations as an outcome measure. Pooled results demonstrated an overall non-significant decline in IGF-1 following metformin intake (WMD: -8.292 ng/ml, 95 % CI: -20.248, 3.664, p = 0.174) with heterogeneity among (p = 0.000,I2 = 87.1 %). The subgroup analyses displayed that intervention duration <12 weeks on children (WMD:-55.402 ng/ml, 95 % CI: -79.845, -30.960, I2 = 0.0 %) significantly reduced IGF-1. Moreover, in age 18 < years older metformin intake (WMD: 15.125 ng/ml, 95 % CI: 5.522, 24.729, I2 = 92.5 %) significantly increased IGF-1 than 18 ≤ years older (WMD:-1.038 ng/ml, 95 % CI: -3.578,1.502,I2 = 78.0 %). Following dose-response evaluation, metformin intake reduced IGF-1 (coefficient for dose-response analysis= -13.14, P = 0.041 and coefficient for liner analysis= -0.066, P = 0.038) significantly based on treatment duration.
CONCLUSION: We found in children, intervention duration <12 weeks yielded significant reductions in IGF-1, whilst paradoxically, in participants >18 years old, metformin intake significantly increased IGF-1. We suggest that caution be taken when interpreting the findings of this review, particularly given the discordant supplementation practices between children and adults.
MATERIALS AND METHODS: We pooled data from 17 observational studies involving 1,699 patients treated with either CSII or non-CSII (including premixed and MDI) regimen. The study outcomes were the frequencies of hypoglycemia, hyperglycemia and/or ketosis. Given the lack of patient-level data, separate analyses for premixed and MDI regimen were not carried out.
RESULTS: The CSII-treated group (n = 203) was older (22.9 ± 6.9 vs 17.8 ± 4.0 years), and had longer diabetes duration (116.7 ± 66.5 vs 74.8 ± 59.2 months) and lower glycated hemoglobin (7.8 ± 1.1% vs 9.1 ± 2.0%) at baseline than the non-CSII-treated group (n = 1,496). The non-CSII-treated group had less non-severe hypoglycemia than the CSII-treated group (22%, 95% CI 13-34 vs 35%, 95% CI 17-55). Of the non-CSII-treated group, 7.1% (95% CI 5.8-8.5) developed severe hypoglycemia, but none from the CSII-treated group did. The non-CSII-treated group was more likely to develop hyperglycemia (12%, 95% CI 3-25 vs 8.8%, 95% CI 0-31) and ketosis (2.5%, 95% CI 1.0-4.6 vs 1.6%, 95% CI 0.1-4.7), and discontinue fasting (55%, 95% CI 34-76 vs 31%, 95% CI 9-60) than the CSII-treated group.
CONCLUSIONS: The CSII regimen had lower rates of severe hypoglycemia and hyperglycemia/ketosis, but a higher rate of non-severe hyperglycemia than premixed/MDI regimens. These suggest that appropriate patient selection with regular, supervised fine-tuning of the basal insulin rate with intensive glucose monitoring might mitigate the residual hypoglycemia risk during Ramadan.
METHODS: A mixed-methods sequential explanatory design was used. This study was conducted at a primary care clinic in an academic hospital from April - November 2018. The insulin PDA was implemented using a tailored implementation intervention, which comprised of 11 strategies aiming to overcome 13 prioritised implementation barriers. Evaluation data were collected from: healthcare administrators such as the head of department, the clinic coordinator, and the nursing officer who oversees the clinic operations, doctors whose tasks were to deliver the insulin PDA to patients, nurses who were responsible for making sure the insulin PDAs were available, and patients with type 2 diabetes who were offered the insulin PDA. The study commenced with the quantitative approach to assess 'Reach', 'Adoption', 'Implementation' and 'Maintenance'of the insulin PDA. Subsequently, qualitative approach was employed and qualitative interviews were conducted with the relevant stakeholders to explain the quantitative outcomes. A total of six IDIs and six FGDs were conducted with healthcare providers (healthcare policymakers: 3, doctors: 35, and staff nurses: 5), and 62 IDIs were conducted with patients.
RESULTS: For 'Reach', 88.9% (n = 48/54) of doctors and 55% (n = 11/20) of nurses attended the insulin PDA training workshops. This was attributed to their self-motivation and the mandate from the Head of Department. The PDA reached 387 patients and was facilitated by the doctors who delivered the PDA to them and their own desire to know more about insulin. Doctors' 'Adoption' of the PDA was high (83.3%, n = 45/54) due to the positive personal experience with the usefulness of the PDA. Only 65.7% (n = 94/143) of patients who received the PDA read it. The degree of 'Implementation' of the PDA varied for different tasks (ranged from 19.2 to 84.9%) and was challenged by patient and system barriers. For 'Maintenance', 80% of the doctors were willing to continue using the PDA due to its benefits.
CONCLUSION: This study highlighted that the implementation of an insulin PDA in a primary care setting is promising. Addressing the issues of social hierarchy, and healthcare providers' roles and responsibilities can further improve implementation outcomes.
OBJECTIVE: The present review discusses the literature concerning the antidiabetic and antioxidant properties of MC focusing on the complication of diabetes mellitus along with its mode of delivery. We found that among the whole part of MC, its fruit extract has been widely studied, therapeutically. The evidence based analysis of the beneficiary effects of MC on the different organs involved in diabetes complication is also highlighted. This review elucidated an essential understanding of MC based drug delivery system in both clinical and experimental studies and appraised the great potential of the protein based MC extract against diabetes mellitus.
CONCLUSION: The review paper is believed to assist the researchers and medical personnel in treating diabetic associated complications.