Showing 4 ideas for tag "2"

Goal 2: Reduce Human Disease

Can Psychological Science Improve Weight Loss?

Will sensitivity to the psychological aspects of obesity, including lifestyle priorities and motivations, improve the efficacy of long-term effectiveness of weight loss and obesity prevention interventions?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

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A primary focus on principles of psychology may result in significantly improved control of the obesity epidemic. Effective interventions could reduce the risk of diabetes, sleep apnea, and hypertension. This research could also affect clinical practice guidelines for weight loss and obesity treatment.

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Psychological science has been successful in developing effective treatments for a number of conditions, including sleep disorders, depressive symptoms, anxiety and phobias. Many of the behavioral principles employed in such interventions (e.g., cognitive restructuring, motivational methods) could be translated for the prevention and treatment of obesity within a reasonable time frame. Additional attention should be directed to the needs of population subgroups in which obesity is most prevalent.
In their Viewpoint article on weight loss intervention research, Pagoto and Appelhans (JAMA, 2013, see attachment) question whether a continued focus on dietary factors in research on weight loss and obesity is warranted. Their commentary raises the importance of attention to the individual psychological characteristics that influence adherence to weight loss interventions rather than dietary composition.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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Goal 2: Reduce Human Disease

Macrovascular disease in Type 1 and Type 2 diabetes mellitus

Do the etiology and vascular pathology of macrovascular disease differ in Type 1 and Type 2 diabetes?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

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Large scale impact on the rethinking of the paradigm of diagnosis, delay (prevention) and potential treatment of CVD due to the high prevalence of Type 2 diabetes and the not so low prevalence of Type 1 diabetes in the nation.

Feasibility and challenges of addressing this CQ or CC

Given the number of patients with Type 2 diabetes who undergo CABG, and the potentially increasing number of Type 1 diabetes patients who live longer and undergo diagnostic testing for CAD, the potential sources of human coronary artery tissue is expected to be sufficient to perform some initial case-control or Type 1 vs Type studies. In addition to coronary arteries, other large arteries could be studied (e.g. cerebral [autopsies], carotid, aortic, femoral, popliteal, dorsalis pedis].
Small post-mortem studies have demonstrated that the atherosclerotic plaque in patients with Type 1 diabetes mellitus is more vulnerable to rupture than the plaque in patients with Type 2 diabetes mellitus. In addition, it has been suggested that CAC score or number of plaques is not as important as the composition of the plaque in predicting cardiovascular events in patients with Type 1 diabetes, since the plaque is more unstable in Type 1 than in Type 2 diabetes mellitus. Thus, some researchers have questioned whether CAC is a good biomarker of CAD in Type 1 diabetes mellitus.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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Goal 2: Reduce Human Disease

Treatment Options for Diabetics and Impact on Cardiovascular Health

As a clinician, over the years I have noted major differences in adverse cardiovascular outcomes in diabetics who are treated with insulin +/- oral agents compared to those only treated with oral agents. Cardiovascular events occur much less often and at a much later timeframe in diabetics ("Type 2/adult onset") treated with insulin as the primary method. Even with newer agents, there may be slight improvement, but... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

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Delaying the onset of injury to vasculature in Type 2 diabetics would have a major impact on quality of life for the diabetic and costs to the healthcare system. Dialysis and related costs are around $200,000/yr and interfere with life and ability to work, leg ulcers are often chronic and in many cases result in amputation.

Feasibility and challenges of addressing this CQ or CC

This study could be performed in the clinical setting or could be completed with chart review to determine diabetics on insulin on insulin and review outcomes. If access to charts for patients continuously treated for five years or longer were available, this study could be done in a shorter timeframe and at less cost. A long term and costly alternative would be to begin a clinical trial. Medical claims data may be an alternative, but it would be important to identify onset of diabetes and treatment for a minimum of five years.

Name of idea submitter and other team members who worked on this idea Patricia Gladowski

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Goal 2: Reduce Human Disease

Risk-benefit of oral hypoglycemic medication in type 2 diabetes

Is an increase in macrovascular endpoints outweighed by the benefit in microvascular end points in new oral type 2 diabetes drugs?

 

It would go against the current regulatory paradigm in type 2 diabetes. Although drug companies do not like the current paradigm, they would prefer to go back to the pre-rosiglitazone state of affairs, in which new drugs had only to prove that they lowered blood glucose and HbA1c.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

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Trials along this line would create a new and more rational paradigm to evaluate the cardiovascular safety of new oral hypoglycemic agents in type 2 diabetes in the context of their incremental benefit in preventing microvascular complications.

Feasibility and challenges of addressing this CQ or CC

Some of the newer oral meds for treating type 2 diabetes, starting with rosiglitazone, have shown no benefit on clinical macrovascular end points, particularly heart failure. The FDA has responded to this by requiring new drugs to undergo large non-inferiority trials demonstrating that these drugs cause no more than a 30% increase in macrovascular endpoints as a precondition for approval. Yet there is no requirement that microvascular events (renal dysfunction and failure, neuropathy, retinopathy and visual loss) even be documented in these trials. So we are allowing new agents like alogliptin and sitogliptin to be marketed without any direct evidence that they do anything good for patients other than lowering glucose and HbA1c levels and with some evidence of adverse CV effects. While it is reasonable to assume that surrogates like lower glucose and HbA1c will translate to reduction in microvascular events, this assumption is based on old studies using different classes of drugs in a different disease population and environment. Even if HbA1c and glucose remain good qualitative surrogates, there is no way to quantitatively compare benefits versus risks of new hypoglycemic drugs compared to placebo or other drugs. Novel statistical methods to look at weighted composites of microvascular and macrovascular endpoints would enable the key question of net benefit to be addressed with a reasonable sample size.

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