METHODS AND DESIGN: This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy.
DISCUSSION: The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02322268.
METHODS: We randomized 108 overweight and obese patients with T2D (46 M/62F; age 60 ± 10 years; HbA1c 8.07 ± 1.05%; weight 101.4 ± 21.1 kg and BMI 35.2 ± 7.7 kg/m2) into three groups. Group A met with RDN to develop an individualized eating plan. Group B met with RDN and followed a structured meal plan. Group C did similar to group B and received weekly phone support by RDN.
RESULTS: After 16 weeks, all three groups had a significant reduction of their energy intake compared to baseline. HbA1c did not change from baseline in group A, but decreased significantly in groups B (- 0.66%, 95% CI -1.03 to - 0.30) and C (- 0.61%, 95% CI -1.0 to - 0.23) (p value for difference among groups over time
METHODS: Reasons for EN FI identified from extensive literature review were prospectively collected in adult mechanically ventilated critically ill patients. Results were reported by descriptive statistics. Baseline and nutritional characteristics between patients who died and those alive at day 60 were compared.
RESULTS: A total of 148 patients receiving ≥1 day of EN for the full 12-day observational period were included in the analysis. About 332 episodes of EN FI were recorded and contributed to 12.8% (4190 hours) of the total 1367 evaluable nutrition days. For each patient, FI occurred for a median of 3 days and the total duration of FI for the entire ICU stay was 24.5 hours. Median energy and protein deficits per patient due to FI for the entire ICU stay were -1780.23 kcal and -100.58 g, respectively. Duration of FI, days with FI, and the amount of energy and protein deficits due to FI were not different between patients who had died and those who were still alive at day 60 (all P > 0.05). About 72% of the total duration of EN FI was due to procedural-related and potentially avoidable causes (primarily human factors), while only about 20% was due to feeding intolerances.
CONCLUSIONS: EN FI occurred primarily due to human factors, which may be minimized by adherence to an evidence-based feeding protocol as determined by a nutrition support team.