Journal of investigative medicine : the official publication of the American Federation for Clinical Research
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Clinical research involving healthy volunteers is important for advancing medical knowledge but raises a variety of ethical issues, many of which stem from the fact that such studies pose risks to research participants without the prospect of medical benefits to them. Ethical issues in research with healthy volunteers are identified and analyzed with the help of an ethical framework consisting of seven ethical requirements for clinical research. These ethical requirements include (1) scientific or social value; (2) scientific validity; (3) fair subject selection; (4) favorable risk-to-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for enrolled subjects.
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Smoking is associated with a decrease in body weight in patients without diabetes mellitus and an increase in insulin resistance and hemoglobin A1c (HbA1c) levels in patients with type 1 diabetes mellitus. Whether smoking is associated with an increase in HbA1c and/or a decrease in body mass index (BMI) in type 2 diabetes mellitus is unresolved, however. Therefore, the objective of this study was to determine the effect of smoking on HbA1c levels and BMI in a cross-section of outpatients with type 2 diabetes mellitus. ⋯ The results of this study suggest that smoking does not have a significant direct effect on BMI or HbA1c in patients with type 2 diabetes mellitus. This conclusion suggests that the relationship between these factors is much more complex than in people without diabetes or in patients with type 1 diabetes mellitus.