Disease Prevention in Clinical Practice Base on Patient Specific Physiology

Summary

It is well known that the Type 2 diabetes and vascular disease are preceded by over ten years by metabolic dysfunction and anatomic changes that can be quantified. In order to develop effective preventive strategies and reduce the cost burden to the health care system, recognition of the earliest pathophysiology of Type 2 diabetes and vascular disease is clinically relevant. The interval retrospective evaluation of data from patient records, reflect the effectiveness of the various treatments implemented in clinical practice.

Prevalence of "prediabetes" among American adults is estimated to be \~84 million, or one out of three Americans. Over a 5-7 year period approximately one third of these prediabetic individuals will progress to type 2 diabetes. Prediabetes is a heterogenous group comprised of individuals with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and increased A1c (5.7-6.4%). Although different pathophysiologies are present in individuals with IFG and IGT, their conversion rate to overt type 2 diabetes mellitus (T2DM) is similar.

Insulin resistance is a common causal feature of many of the pathophysiologic mechanisms linking macrovascular disease and type 2 diabetes. Because hyperglycemia is the major factor responsible for the development of microvascular complications, it logically follows that prevention of progression of prediabetes to overt diabetes should retard/prevent the development of the microvascular complications. From the measurement of plasma glucose, insulin, and c-peptide levels during the oral glucose tolerance test, one can derive measures of the two core defects responsible for the development of T2DM, i.e. insulin resistance and beta cell dysfunction as well as the degree of dysglycemia.

By combining a standard medical evaluation with the evaluation of cardiovascular biomarkers, patients at intermediate risk of vascular disease can be identified. In these patients, carotid intima media thickness (IMT) and carotid plaque evaluation is offered to attempt to clarify risk.

The hypothesis of this observational study is that the characterization of the physiology and anatomy of patients at risk of developing type 2 diabetes and/or cardiovascular disease can stratify risk of developing disease and direct treatment strategies tailored to the identified physiologic defect, leading to improvements in the delay or prevention of disease.

Conditions

• PreDiabetes
• Insulin Resistance
• Type2 Diabetes
• NASH - Nonalcoholic Steatohepatitis
• Diastolic Dysfunction
• Dementia
• Atrial Fibrillation
• Cancer
• Atherosclerosis
• Carotid Plaque

Interventions

OTHER

Lifestyle modification in routine care of patients

Diabetes Prevention Program Lifestyle recommendations and non-investigational pharmacotherapy in routine care of patients

Sponsors & Collaborators

• Pacific Coast Family Medical Group

  lead OTHER

Principal Investigators

• John P Armato, MD · Providence St Josephs Health

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-05

Primary Completion

2027-09-30

Completion

2027-09-30