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Obesity ; 29(SUPPL 2):86, 2021.
Artigo em Inglês | EMBASE | ID: covidwho-1616064


Background: Growing interest in very low carbohydrate diets, and in particular the ketogenic diet, has been met with some resistance. Important gaps exist regarding what diet to compare to the ketogenic diet. The objective of this study was to compare a Well Formulated Ketogenic Diet (WFKD) with a Mediterranean-Plus diet (Med-Plus;Mediterranean with emphasis on eliminating added sugars and refined grains), in a crossover study, stratified by diabetes status (T2D vs Prediabetes). Methods: The intervention involved having participants follow the WFKD and Med-Plus, for 12 weeks each, in random order. All meals were provided for the first 4 weeks of each diet phase (food delivery);then participants were responsible for purchasing and preparing their own foods (self-provided). The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes included weight, glucose as measured by continuous glucose monitor (CGM), and cardiometabolic risk factors, such as fasting insulin, glucose, and lipids. Results: Among participants randomized (n = 42), 33 had complete data at both diet phases (some missing data attributable to COVID disruptions). Participants were 60 ± 9 (mean ± sd) years of age, 61% men, with BMI 31 ± 5 kg/m2. Adherence for both diets was higher during the food delivery than the self-provided phase, but similar between diets for both phases. HbA1c concentrations were not significantly different between diets, but average CGM glucose levels were significantly lower during the WFKD compared to Med-Plus (p = 0.03). Additionally, WFKD induced a significantly greater decrease in triglycerides (-16% vs -5%, p = 0.02) and greater increase in LDL-C levels (10% vs -5%, p = 0.01), compared to Med-Plus. Weight change on WFKD vs Med-Plus was -8% vs -7% (p = 0.05). Sensitivity analyses largely confirmed the main findings. Conclusions: Participants improved in glucose control and weight management on both diets relative to baseline;however, glucose control was superior on the WFKD. Some caution is warranted when interpreting these results due to pandemic disruptions and a small sample size. A fair comparison of the two diets should also take into consideration non-glycemic effects.

European Heart Journal ; 42(SUPPL 1):3177, 2021.
Artigo em Inglês | EMBASE | ID: covidwho-1554235


Background: The COVID-19 pandemic has curtailed clinical trial activity significantly. Decentralized clinical trial (DCT) designs may lower cost, expand trial access, and reduce exposure risk for patients and staff. Whether such designs can be used for large, pivotal drug trials is not known. Purpose: We performed a feasibility study to inform whether a large phase 3 Cardiovascular DCT can achieve high quality trial results and also withstand health crises such as the COVID-19 pandemic. The DeTAP (Decentralized Trial in Afib Patients) was a single-arm, observational study that integrated a suite of digital health technologies, including paired home sensor devices, into a 100% virtual trial experience for atrial fibrillation (AF) patients on anticoagulation. Methods: We recruited 100 AF patients over age 55 on oral anticoagulation (OAC) by traditional methods or by social media ads placed Californiawide. Subjects completed an online prescreening, uploaded their active OAC prescription, and completed an e-consent via SMS message link. Participants downloaded a customized study app to integrate surveys and data from study-supplied wireless blood pressure (BP) and 6 lead EKG sensors (Figure 1A). Participants completed pre- and post-study engagement surveys, weekly OAC adherence surveys, 4 study televisits, 4 ECG/BP readings, and 4 post-study surveys over a 6 month period. The primary endpoints were protocol engagement-based measurements that quantified percent completion of: 1) televisits 2) surveys, 3) ECG/BP readings requirements. Secondary endpoints were the % changes in: 1) OAC adherence (OACA), 2) nuisance bleeding (NB), 3) individual patient engagement surveys. Results: 100 participants were recruited in 26 days (traditional: 6 in 2 weeks;social media: 94 in 12 days) with a dramatic surge in enrollment driven by social media ads (Figure 1B, Table). A recruitment overflow occurred with >200 eligible candidates on a waitlist. All key study completion metrics showed high compliance: televisit (91%);surveys (85%);ECG/BP completion (90%). Overall OACA was unchanged, but for subjects who reported low initial OACA, there was significant improvement at 6 months (85±16% to 98±6%;p=0.002). 47 participants (57%) reported NB, which did not correlate with OACA. Participant engagement measure scores (PAM-13) trended higher (baseline, 70%;6 months, 74%, p=0.32). Lastly, study participants exhibited strong interest in participating in a larger experimental drug DCT study (90%) in the future. Conclusion: The DeTAP study, conducted fully during the COVID-19 pandemic, demonstrates that a decentralized CV medical intervention trial is feasible and can achieve rapid recruitment, high study retention, physiologic and adverse event reporting, and high study engagement via the proper integration of digital technologies and a dedicated DCT study coordination effort. These findings could be informative for virtualizing large pivotal clinical trials at scale.