Since diabetic complications occur in those that show more glycative and oxidative stress, we have validated their predictive power in ground-breaking outcome trials to create diagnostic blood tests for clinical use.
To study the clinical efficacy and utility of these tests we will identify those at high risk (HR) before DKD and CVD are apparent. Primary endpoints are achievement of rigorous glycemic and proposed treatment... more »

Submitted by: NEI Collaborative Clinical Research Program Officers

Diabetes often leads to end-organ complications, one of which is diabetic retinopathy and vision loss. This has a significant impact on quality of life for the diabetic patient. Finding genetic determinants would be predictive for this outcome within the diabetic population and may potentially lead to therapeutic interventions.

A major advance in diabetes treatment is the finding that specific glucose-lowering drugs reduce the risk of cardiovascular disease. The results were tempered by the increased risk of amputations for the groups that received the SGLT2 inhibitor, canagliflozin. The generalizability of this finding is unknown. An understanding of the association of specific diabetes drugs with lower extremity complications will allow... more »

Diabetic kidney disease (DKD) is the leading cause of end-stage renal disease (ESRD), the most serious and expensive stage of chronic kidney disease (CKD). Pre-ESRD stages of CKD are also associated with significant health care burden. DKD can progress to ESRD with or without albuminuria. Better understanding of risk factors attributable to the development of albuminuric and non-albuminuric DKD, and to their progression... more »

Although the presence of a relationship between physical activity and diabetic foot ulcers is widely accepted, there is limited understanding of this relationship. Most studies to date have included sample sizes less than 100 participants and monitored physical activity for less than 6 months (often for only a period of several weeks). This prospective longitudinal study will evaluate the association of physical activity... more »

Transient ischemic attack (TIA) is a frequent precursor to stroke. Studies of modern treatments (e.g., carotid endarterectomy and carotid artery stenting) do not consider TIA as an indicator for treatment, nor which treatments may be more effective following a TIA. All of Us provides a unique opportunity to not only examine the interaction between TIA and treatment to prevent subsequent strokes, but also to suggest... more »

Empaglifozin, a highly selective sodium-glucose cotransport 2 (SGLT2) inhibitor, has been shown to significantly reduce major adverse cardiovascular (CV) events and hospitalization for heart failure in patients with type 2 diabetes (T2DM) and established CV disease. The generalizability of this finding to lower risk population is unknown. We propose to compare cardiovascular outcomes in a more heterogeneous population... more »

This is 26-wk study of 60 patients in 2:1 ratio, cohort 1 on standard of care (SOC) & IV Insulin Infusion vs SOC alone for diabetes. Patients labs (HA1c, C-peptide, Insulin, CrClearance), BP, HR, and evidence of Neuropathy, retinopathy, nephropathy, Fatigue and hypertension will be measured at the beginning of the study, then every 12 weeks thereafter. After the first 12 weeks, the cohort 2 will cross-over to cohort... more »

Peripheral neuropathy is common in persons with diabetes and those over 40, and can be measured with validated claims data. The main disease risk factors, other than hyperglycemia, are unknown. We propose a first in kind study to simultaneously address how behavioral (diet, exercise, sleep), environmental (air quality, food access), and genetic factors influence the development of neuropathy and whether these factors... more »

Diabetes places people at risk for problems with skin integrity, and complications that can risk the patient's limbs and life. Friction and shear forces are known extrinsic factors in pressure injuries and diabetic foot wounds, but this is not consistently addressed as part of the treatment plan. This can contribute to complications, and a higher cost of care. Better understanding of this gap in treatment may allow increased... more »