Summary: In healthy male participants aged 18-65 years with overweight or obesity (BMI 25.0-34.9 kg/m²), including Japanese and non-Asian individuals, single ascending subcutaneous doses of zalfermin (2-180 mg), a novel long-acting FGF21 analog demonstrated dose-proportional pharmacokinetics with approximately 120-hour half-life and significant improvements in plasma lipid profiles compared to placebo, though it was associated with mild to moderate gastrointestinal adverse events at higher doses, with no serious adverse events or deaths. PICO Description Population Healthy male participants (n=98) aged 18-65 years with BMI of 25.0-34.9 kg/m², including both Japanese and non-Asian individuals to assess cross-ethnic pharmacokinetics. Intervention Single subcutaneous doses…
Author: FWA
Summary: In adults with metabolic syndrome, a diet substituting animal protein with 70% plant-based protein significantly improved anthropometric indices, reduced blood pressure and atherogenic indices, and increased adropin levels compared to a diet with 70% animal-based protein, with no statistically significant difference in overall MetS component changes between groups. PICO Description Population Adults diagnosed with metabolic syndrome (MetS), mean age approximately 44 years. Intervention A diet composed of 70% plant-based protein and 30% animal-based protein over a 10-week period, under slight calorie restriction. Comparison A corresponding diet with the reverse proportion: 70% animal-based protein and 30% plant-based protein, also under…
Summary: In patients with diabetic foot ulcers (DFUs) receiving home healthcare, telemedicine-based home healthcare interventions focusing on wound management and patient self-care education significantly promoted wound healing and improved self-management behaviour compared to conventional outpatient face-to-face care in clinical settings, though it was associated with no major reported adverse effects, with suggestions for further app development to optimize care delivery. PICO Description Population Patients diagnosed with diabetic foot ulcers (DFUs) receiving home healthcare, representing individuals requiring ongoing wound management who may face barriers to frequent clinic visits. Intervention Telemedicine-based home healthcare interventions incorporating remote wound assessment, patient self-care education, and…
Summary: In patients with diabetic macular edema (DME) enrolled in the Phase III VISTA trial (n=443 eyes), intravitreal aflibercept injections (IAI) administered with machine learning-enabled OCT segmentation analysis over 100 weeks significantly improved ellipsoid zone (EZ) integrity and reduced retinal fluid volume compared to laser photocoagulation treatment, though it was associated with potential injection-related adverse events such as intraocular inflammation and elevated intraocular pressure. PICO Description Population Patients with diabetic macular edema (DME) enrolled in the Phase III VISTA trial, representing individuals with vision-threatening diabetic eye disease requiring intervention. Intervention Intravitreal aflibercept injections (IAI) with longitudinal assessment using a machine…
Summary: In patients with type 2 diabetes mellitus and chronic kidney disease, finerenone (a non-steroidal mineralocorticoid receptor antagonist) administered according to study protocol significantly reduced albuminuria but did not alter arterial stiffness as measured by pulse wave velocity compared to placebo control with standard care, though it was associated with potential hyperkalemia requiring monitoring, with renal benefits attributed to reduction in intraglomerular pressure rather than vascular effects. PICO Description Population Patients with type 2 diabetes mellitus and chronic kidney disease, representing a high-risk population for both cardiovascular and renal disease progression. Intervention Finerenone, a non-steroidal selective mineralocorticoid receptor antagonist, administered…
Summary: In patients with complex diabetic foot ulcers (DFUs) involving exposed bone, tendon, muscle, and/or joint capsule with controlled osteomyelitis (N=118), adjunctive cryopreserved ultra-thick human amniotic membrane derived from umbilical cord (cUC) applied at baseline and reapplied every ≥4 weeks if healing stalled for up to 4 applications demonstrated comparable healing rates at 26 weeks (66.1% vs 59.8%, p=0.40) and 50 weeks (77.1% vs 71.6%, p=0.29) with trend toward higher long-term healing compared to standard of care alone including surgical debridement, bone resection, wound dressings, offloading, and 6-week systemic antibiotics, with comparable adverse event rates (89.8% vs 87.3%). PICO Description…
Summary: In patients with complex diabetic foot ulcers (DFUs) involving exposed bone, tendon, muscle, and/or joint capsule with controlled osteomyelitis, adjunctive cryopreserved ultra-thick human amniotic membrane derived from umbilical cord (cUC) demonstrated comparable healing rates to standard of care (SOC) alone, which included debridement, wound management, offloading, and systemic antibiotics, though it was associated with similar adverse event rates. PICO Description Population Adults with complex diabetic foot ulcers (DFUs) exhibiting exposed bone, tendon, muscle, and/or joint capsule, with controlled osteomyelitis. Intervention Adjunctive treatment with cryopreserved ultra-thick human amniotic membrane derived from umbilical cord (cUC), applied at baseline and reapplied every…
Summary: In young patients with obesity and generalized gingivitis, systemic administration of cerium oxide nanoparticles (Cerera) for 10 days following professional dental hygiene demonstrated significant reductions in oxidative and nitrosative stress markers, increased catalase activity, and normalization of oral colonization resistance compared to local treatment with Nanosept solution (CNPs combined with chlorhexidine) applied twice daily for 5 days, with both groups achieving gingivitis resolution without adverse effects. PICO Description Population Young patients diagnosed with obesity and generalized gingivitis, representing a population with both systemic metabolic dysfunction and local oral disease. Intervention Systemic administration of Cerera (cerium oxide nanoparticles) for 10…
Summary: In adults with obesity and/or type 2 diabetes (mean age 47.9 years, 74% female) referred for physical activity intervention, the Kiplin digital health program combining face-to-face sessions, online supervised sessions, and app-based gamified modules over 3 months demonstrated significantly greater increases in daily steps (+1085 during intervention, +1775 at follow-up) and moderate-to-vigorous physical activity compared to standard hospital-based supervised physical activity with 36 in-person sessions over 12 weeks, with notable individual variability in response patterns and comparable cost-effectiveness. PICO Description Population Adults with obesity and/or type 2 diabetes (mean age 47.9 years, 74% female) referred to University Hospital of…
Summary: In adults with obesity seeking to increase physical activity and improve weight management, a digital health physical activity program integrating gamification elements (points, achievements, challenges, social features) demonstrated significantly increased physical activity levels with potential for sustained behavior change compared to standard usual care without digital or gamified components, though it was associated with marked individual heterogeneity in response, with some participants thriving while others showed minimal engagement. PICO Description Population Adults with obesity enrolled to assess physical activity engagement and weight management outcomes. Intervention Digital health physical activity program integrating gamification elements including points, achievements, challenges, leaderboards, and…