METHODS: Sixteen New Zealand white rabbits, 20 to 24 weeks old, were randomly divided into 4 experimental groups. Modified hyrax expanders were placed across their interfrontal sutures and secured with miniscrew implants located bilaterally in the frontal bone. The hyrax appliances were activated as follows: group 1 (control), 0.5-mm per day expansion for 12 days; group 2, 1-mm instant expansion followed by 0.5 mm per day for 10 days; group 3, 2.5-mm instant expansion followed by 0.5 mm per day for 7 days, and group 4, 4-mm instant expansion followed by 0.5 mm per day for 4 days. After 6 weeks of retention, sutural separation and sutural bone modeling were assessed by microcomputed tomography and quantified. Statistical analysis was performed using Kruskal Wallis and Mann-Whitney U tests and the Spearman rho correlation (P <0.05).
RESULTS: Median amounts of sutural separation ranged from 2.84 to 4.41 mm for groups 1 and 4, respectively. Median bone volume fraction ranged from 59.96% to 69.15% for groups 4 and 3, respectively. A significant correlation (r = 0.970; P <0.01) was observed between the amounts of instant expansion and sutural separation.
CONCLUSIONS: Pending histologic verifications, our findings suggest that the protocol involving 2.5 mm of instant expansion followed by 0.5 mm per day for 7 days is optimal for accelerated sutural expansion. When 4 mm of instant expansion was used, the sutural bone volume fraction was decreased.
RESEARCH DESIGN AND METHODS: Outcomes of 736 patients with T2DM who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at an academic center (2004-2012) and had ≥5 years' glycemic follow-up were assessed. Of 736 patients, 425 (58%) experienced diabetes remission (HbA1c <6.5% [48 mmol/mol] with patients off medications) in the 1st year after surgery. These 425 patients were followed for a median of 8 years (range 5-14) to characterize late relapse of diabetes.
RESULTS: In 136 (32%) patients who experienced late relapse, a statistically significant improvement in glycemic control, number of diabetes medications including insulin use, blood pressure, and lipid profile was still observed at long-term. Independent baseline predictors of late relapse were preoperative number of diabetes medications, duration of T2DM before surgery, and SG versus RYGB. Furthermore, patients who relapsed lost less weight during the 1st year after surgery and regained more weight afterward. Prediction models were constructed and externally validated.
CONCLUSIONS: While late relapse of T2DM is a real phenomenon (one-third of our cohort), it should not be considered a failure, as the trajectory of the disease and its related cardiometabolic risk factors is changed favorably after bariatric surgery. Earlier surgical intervention, RYGB (compared with SG) and more weight loss (less late weight regain) are associated with less diabetes relapse in the long-term.
METHODS: In this multicenter randomized trial, critically ill patients will be randomized to receive supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition to achieve a high amount of enteral protein (range of 2-2.4 g/kg/day) or no supplemental enteral protein to achieve a moderate amount of enteral protein (0.8-1.2 g/kg/day). The primary outcome is 90-day all-cause mortality; other outcomes include functional and health-related quality-of-life assessments at 90 days. The study sample size of 2502 patients will have 80% power to detect a 5% absolute risk reduction in 90-day mortality from 30 to 25%. Consistent with international guidelines, this statistical analysis plan specifies the methods for evaluating primary and secondary outcomes and subgroups. Applying this statistical analysis plan to the REPLENISH trial will facilitate unbiased analyses of clinical data.
CONCLUSION: Ethics approval was obtained from the institutional review board, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia (RC19/414/R). Approvals were also obtained from the institutional review boards of each participating institution. Our findings will be disseminated in an international peer-reviewed journal and presented at relevant conferences and meetings.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04475666 . Registered on July 17, 2020.