Mayo Clinic proceedings
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Mayo Clinic proceedings · Feb 2024
ReviewClinical Trials for Special Populations: Children, Older Adults, and Rare Diseases.
Research cannot maximize population health unless it improves health for all members of the public, including special populations such as children, older adults, and people living with rare diseases. Each of these categories require special considerations when planning and performing clinical trials, and common threads of ethical conduct of research in vulnerable populations appear throughout. In this review, definitions of each of the three categories of special population (children, older adults, and rare diseases) are discussed in terms of US research regulations, the unique challenges to conducting clinical trials for these special populations, critical ethical issues, and opportunities for innovative ways to design and operationalize clinical trials in special populations. Additional critical attention is focused on factors that influence the generalizability of study results to reduce health disparities, as well as the importance of community engagement and advocacy groups that can help to educate potential trial participants of the benefits of clinical trial participation.
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Mayo Clinic proceedings · Feb 2024
Progression to Insulin Therapy in Patients With Type 2 Diabetes According to Cardiorespiratory Fitness, Body Mass Index, and Statin Therapy.
To evaluate the association between statin therapy, cardiorespiratory fitness (CRF), body mass index (BMI), and progression to insulin therapy in type 2 diabetes mellitus (T2DM). ⋯ In patients with T2DM, the statin-related progression to insulin therapy was associated with relatively low CRF and high BMI levels. The progression rate was mitigated by increased CRF regardless of BMI. Clinicians should foster regular exercise for patients with T2DM to enhance CRF and to lessen the rate of progression to insulin therapy.