Showing 7 ideas for tag "diabetes"

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?

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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

SLEEP DISORDERS AS A MODIFIABLE RISK FACTOR FOR CHRONIC DISEASE

There is developing evidence that sleep disorders, in particular obstructive sleep apnea and inadequate sleep, can influence the course of other chronic diseases. Observational studies show that CPAP treatment of patients with pre-diabetes who have OSA reduces the incidence of future diabetes. Moreover, animal and human data indicate that insufficient sleep and sleep apnea can affect the rate of progression of neurodegenerative... more »

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

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This question will have considerable impact. Sleep apnea is an independent risk factor for insulin resistance. Moreover, observational studies show that treatment of OSA reduces the rate of future diabetes compared to that which occurs in untreated OSA. Therefore, identifying OSA and treating this could have a profound impact on reducing the rate of diabetes, i.e., a preventative strategy.

Both sleep loss and obstructive sleep apnea have also been shown to be risk factors for subsequent development of Alzheimer’s disease. This has been shown in mouse models and in epidemiological studies to address whether insufficient sleep and sleep apnea are independent risk factors for development of Alzheimer’s disease, in particular accelerating their onset. Determining whether this is so and whether interventions to treat these sleep disorders delay onset of diabetes and Alzheimer’s disease would have profound public health significance.

Feasibility and challenges of addressing this CQ or CC

These disorders are extremely common so that recruitment of subjects is not challenging. Moreover, new technology reduces protocol burden to assess individuals. All studies can be done in the patients’ home. There are existing cohort studies focused on diabetes and the Alzheimer’s Center program that could be used for these studies. Thus, the studies are extremely feasible in the near term.

Name of idea submitter and other team members who worked on this idea Sleep Research Society

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Goal 2: Reduce Human Disease

Intervening on Metabolic Derangements Induced by Allogeneic Hematopoietic Stem Cell Transplantation

Can standardized screening, pharmacological/behavioral prevention, and optimized treatment of metabolic complications after allogeneic hematopoietic stem cell transplantation improve outcomes and decrease transplant-related morbidity and mortality?

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

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The development of type 2 diabetes mellitus (DM) is a significant complication for long-term cancer survivors including patients treated with allogeneic hematopoietic stem cell transplantation (HCT). New onset, post-transplant DM (PTDM) occurs in up to 60% of HCT recipients, often precedes the development of acute GVHD, and negatively impacts survival. Type 2 DM is a complex disorder characterized by hyperglycemia, insulin resistance, and relative insulin insufficiency. The transition from insulin resistance to diabetes is associated with an inflammatory milieu characterized by the accumulation of IFN-γ secreting T cells (Th1 cells) and depletion of immunosuppressive Foxp3+ regulatory T cells in visceral organs and adipose tissue. Similarities exist between the immunology of insulin resistance and GVHD. However, the initiating events and mechanisms that culminate in PTDM development remain understudied, and formal recommendations for screening and treatment are lacking. All pregnant women undergo screening for diabetes, which complicates 2-10% of pregnancies in the United States. About 30% of renal transplant patients develop diabetes (NODAT), and current recommendations include weekly fasting blood glucose measurements. No such recommendations exist for HCT recipients, of whom up to 60% will develop de novo PTDM. Through clinical investigation, effective strategies for screening, preventing, and optimally treating PTDM can be developed and HCT outcomes improved.

Feasibility and challenges of addressing this CQ or CC

It is time to make up for lost (scientific) ground. It will require the efforts of a large network like the BMT-CTN to quickly address problems, answer important scientific questions, and raise awareness for a frequent but understudied complication following HCT.

Name of idea submitter and other team members who worked on this idea Brian Engelhardt and Madan Jagasia, Vanderbilt University

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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.

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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 »

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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.

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

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Goal 2: Reduce Human Disease

Environmental induction of congenital heart defects and finding means of prevention

Congenital heart defects (CHDs) continue to be the leading cause of death among all infants with birth defects. It is reported that approximately 10% of cardiac congenital anomalies have a genetic basis. An equal percentage, or ~10%, is due to environmental factors. For ~60% the etiology is unknown and considered to have a multifactorial basis, eg, environmental agents having a role against a specific genetic background,... more »

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

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College drinking is up especially among young women. Women of both high and low income levels drink, may be smoking marijuana, or are exposed to other environmental toxicants. Are there gender effects, as it has been reported that in the US, more male babies undergo severe cardiac surgeries than female. Few grants are presently funded that take a teratological approach to understanding mechanisms underlying induction of congenital heart defects that can occur before a women realizes being pregnant. The embryo may already have been harmed by then and the effects last a lifetime for the child. High dose folate may be preventative of CHDs and this needs to be better defined and the effects of high folate doses on the adult and fetus need to be analyzed. A possible role for gender should be defined.

Feasibility and challenges of addressing this CQ or CC

A recommended goal is to emphasize the submission of grants specifically addressing the etiology of congenital heart defects due to environmental factors and their prevention, using cell and molecular teratological approaches. Reinstate a study section on Teratology and Toxicology of Birth Defects made up of PIs working in those fields. There used to be four such study sections and were all removed years back. One such section should be reinstated. Current study sections lack such individuals on the panels due to this area receiving little funding. The neural field is way ahead in funding this topic and as a result the heart tends not to be mentioned in available literature that is provided to women of child-bearing age. Yet the risk for heart anomalies is equally as high and important as are effects on neural development. Similarly, both have lifelong consequences for the individual physically and psychologically and in cost to society with repeating hospitalizations and surgeries. Effects on the heart may be so severe that death occurs already in utero and may not always be counted among the epidemiological studies.

Name of idea submitter and other team members who worked on this idea Kersti K. Linask, PhD

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