METHODS: We searched MEDLINE (via PubMed) and Science Direct databases for articles that included the component of nutrition for adult patients with type 2 diabetes (T2D), published in English between 2010 and 2020.
RESULTS: Fourteen studies met the criteria. Eight of 14 studies had an intervention with a control arm. In comparison to the control group, all studies (n = 8) showed a reduction in hypoglycemic events. However, only half of these studies (n = 4) had shown at least one positive clinical outcome. Features of nutrition therapy that appeared to have favorable clinical outcomes include individualized caloric prescription; distributing carbohydrates equally between Suhoor, Iftar and snacks; providing meal plans; adjusting food intake to suit Ramadan; and incorporating diabetes-specific formula as part of Suhoor or snack.
CONCLUSIONS: The review provides evidence for the effectiveness of Ramadan-focused nutrition therapy among people with T2D and identifies key features of nutrition therapy that may provide favourable clinical outcomes. Additional data on dietary quality and adequacy during Ramadan fasting warrants further studies.
METHODS: Phytochemicals, along with their potential antidiabetic property, were classified according to their basic chemical skeleton. The chemical structures of all the compounds with antidiabetic activities were elucidated in the present review. In addition to this, the distribution and their other remarkable pharmacological activities of each species are also included.
RESULTS: The scrutiny of literature led to the identification of 44 plants with antidiabetic compounds (70) and other pharmacological activities. For the sake of information, the distribution of each species in the world is given. Many plant derivatives may exert anti-diabetic properties by improving or mimicking insulin production or action. Different classes of compounds including sulfur compounds (1-4), alkaloids (5-11), phenolic compounds (12-17), tannins (18-23), phenylpropanoids (24-27), xanthanoids (28-31), amino acid (32), stilbenoid (33), benzofuran (34), coumarin (35), flavonoids (36-49) and terpenoids (50-70) were found to be potential active compounds for antidiabetic activity. Of the 70 listed compounds, majorly 17 compounds are obtained from triterpenoids, 13 from flavonoids and 7 from alkaloids. Among all the 44 plant species, the maximum number (7) of compounds were isolated from Lagerstroemia speciosa followed by Momordica charantia (6) and S. oblonga with 5 compounds.
CONCLUSION: This is the first paper to summarize the established chemical structures of phytochemicals that have been successfully screened for antidiabetic potential and their mechanisms of inhibition. The reported compounds could be considered as potential lead molecules for the treatment of type-2 diabetes. Further, molecular and clinical trials are required to select and establish therapeutic drug candidates.
METHODS: A total of 1065 patients aged ≥18 years with T2DM initiating insulin therapy in normal clinical course were enrolled from Hong Kong, Malaysia, Philippines, Taiwan and Thailand. Participants' data was recorded by the treating physicians. Patient-reported outcomes (PROs) were assessed using questionnaires completed by participants.
RESULTS: The mean age of patients was 57.2 years with mean glycosylated hemoglobin (HbA1c) of 10.0%. About 66% of patients had an HbA1c ≥9.0% at insulin initiation despite 74% of them being on two or more oral antidiabetic agents at the time of insulin initiation. Basal insulin was initiated in 72% and premixed insulin in 27% of patients. Changes in insulin therapy was observed in 63% of patients and, by the end of study, 28% achieved HbA1c levels of <7.5%. The proportion of patients completely satisfied with their insulin treatment increased over the study course and the quality of life (QoL) score increased from baseline to the study end.
CONCLUSION: As high HbA1C levels indicate a delayed start of insulin therapy, timely initiation and early intensification of insulin therapy is necessary in the region to achieve adequate glycemic control in time and prevent diabetes complications. Data from PROs suggests that the insulin treatment improves QoL in most patients.
METHODS: DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6-8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14-18 weeks. A second visit (V1) was conducted 4-6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting ≥1 symptomatic HE. Changes in HbA1c, fasting plasma glucose (FPG), and body weight were secondary endpoints.
RESULTS: The proportion of patients reporting ≥1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA1c (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m2) between V0 and V1 (p
METHODS: A randomized controlled trial was carried out in a university hospital in Malaysia. Women with lifestyle-controlled gestational diabetes scheduled to receive clinically indicated antenatal corticosteroids (dexamethasone) were randomized to 12-mg 12 hourly for one day (2 × 12-mg) or 6-mg 12-hourly for two days (4 × 6-mg). 6-point (pre and 2-h postprandial) daily self-monitoring of capillary blood sugar profile for up to 3 consecutive days was started after the first dexamethasone injection. Hyperglycemia is defined as blood glucose pre-meal ≥ 5.3 or 2 h postprandial ≥ 6.7 mmol/L. The primary outcome was a number of hyperglycemic episodes in Day-1 (first 6 BSP points). A sample size of 30 per group (N = 60) was planned.
RESULTS: Median [interquartile range] hyperglycemic episodes 4 [2.5-5] vs. 4 [3-5] p = 0.3 in the first day, 3 [2-4] vs. 1 [0-3] p = 0.01 on the second day, 0 [0-1] vs. 0 [0-1] p = 0.6 on the third day and over the entire 3 trial days 7 [6-9] vs. 6 [4-8] p = 0.17 for 6-mg vs. 12-mg arms, respectively. 2/30 (7%) in each arm received an anti-glycemic agent during the 3-day trial period (capillary glucose exceeded 11 mmol/L). Mean birth weight (2.89 vs. 2.49 kg p
METHODS: Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16.
RESULTS: In total, 2383 women from 17 mainly European countries were enrolled in the study: 2122 with T1D and 261 with T2D; mean age was 31 and 33 years, and duration of diabetes was 15 and 6 years, respectively. For women with T1D or T2D, 63% and 75%, respectively, received basal and rapid-acting insulin, 36% and 3% rapid-acting insulin only, 0.7% and 14.0% basal insulin only, 0.2% and 5.4% premix insulin, 0.0% and 1.2% injectable glucagon-like peptide-1 receptor agonist treatment without insulin. In women with T1D or T2D, respectively, during early pregnancy, 59% and 62% had HbA1c <7.0% (53 mmol/mol); 16% and 36% reported not taking folic acid before or during early pregnancy. Overall, >40% of women had ≥1 chronic concomitant condition (predominantly thyroid disease or hypertension). Retinopathy was the most commonly reported diabetic complication. The most commonly reported previous pregnancy complication was miscarriage.
CONCLUSIONS: Baseline data from this large multinational population of women with pre-existing diabetes indicate that sub-optimal glycemic control, poor pregnancy planning, and chronic concomitant conditions were common in early pregnancy.
METHODS: ARISE is a ~26-wk-long, prospective, non-interventional, single-arm study of patients with type 2 diabetes (T2D) initiating IDegAsp treatment. Approximately 1112 patients with T2D aged ≥18 years previously on anti-hyperglycaemic drugs except IDegAsp will be enroled across six countries from 15 Aug 2019 to 12 Nov 2020. IDegAsp treatment will be initiated at the physicians' discretion and as per the local label. Key exclusion criteria include previous participation, or previous IDegAsp treatment. The primary and secondary endpoints are change in HbA1c from baseline (wk 0) to study end (wk 26-36) and the proportion of patients achieving the target HbA1c level of <7% at the study end, respectively. A mixed model for repeated measurements will analyse the primary endpoint.
CONCLUSION: Between-country differences in the prescription patterns of glucose-lowering agents in people with T2D warrant examination of their clinical use in different geographical settings. The ARISE study is designed to assess the clinical use of IDegAsp from real world in six different countries. Findings from the ARISE study will supplement those of previous randomised controlled studies by establishing real-world evidence of IDegAsp use in the participating countries.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04042441. Registered 02 August 2014, https://clinicaltrials.gov/ct2/show/NCT04042441.
METHODS: This was a multi-centre, open-label randomised crossover study. Twenty-four overweight/obese T1DM patients aged ⩾18 years old with HbA1c ⩾ 7.0% (53 mmol/mol) were recruited and randomised into two study arms. For first 6-week, one arm remained on standard of care (SOC), the other arm received metformin, adjunctive to SOC. After 2-week washout, patients crossed over and continued for another 6 weeks. Glycaemic variability, other glycaemic parameters and metabolic profile were monitored.
RESULTS: There were significant reduction in metformin group for GV: mean (0.18 ± 1.73 vs -0.95 ± 1.24, p = 0.014), %CV (-15.84 (18.92) vs -19.08 (24.53), p = 0.044), glycemic risk assessment of diabetes equation (-0.69 (3.83) vs -1.61 (3.61), p = 0.047), continuous overlapping net glycaemic action (0.25 ± 1.62 vs -0.85 ± 1.22, p = 0.013), J-index (-0.75 (21.91) vs -7.11 (13.86), p = 0.034), time in range (1.13 ± 14.12% vs 10.83 ± 15.47%, p = 0.032); changes of systolic blood pressure (2.78 ± 11.19 mmHg vs -4.30 ± 9.81 mmHg, p = 0.027) and total daily dose (TDD) insulin (0.0 (3.33) units vs -2.17 (11.45) units, p = 0.012). Hypoglycaemic episodes were not significant in between groups.
CONCLUSION: Metformin showed favourable effect on GV in overweight/obese T1DM patients and reduction in systolic blood pressure, TDD insulin, fasting venous glucose and fructosamine.