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Diabetes Project

Diabetes is considered by many to be an epidemic in the United States. It is a particularly devastating disease among the native American populations. The prevalence, increasing incidence, associated mortality and morbidity all point to diabetes as one of the most serious health challenges facing us.

There are two main forms of diabetes. Type 1 diabetes is due primarily to autoimmune-mediated destruction of pancreatic beta-cell islets, resulting in absolute insulin deficiency. People with type 1 diabetes must take exogenous insulin for survival to prevent the development of ketoacidosis. Its frequency is low relative to type 2 diabetes, which accounts for over 90% of cases globally. Type 2 diabetes is characterized by insulin resistance and/or abnormal insulin secretion, either of which may predominate. People with type 2 diabetes are not dependent on exogenous insulin, but may require it for control of blood glucose levels if this is not achieved with diet alone or with oral hypoglycemic agents.

Diabetes mellitus affects more than 6% of the US population, with the great majority having type 2 diabetes mellitus (DM). In some older groups, the prevalence of DM and its metabolic forerunner, impaired glucose tolerance (IGT), approaches 25%. Throughout the past decade, 1990 to 1998, diagnosed diabetes rose 33 percent (4.9 percent to 6.5 percent) among U.S. adults. A follow-up study by the CDC showed that in 1999 alone, increases in diabetes were noted in every category examined including sex, age, race, education, weight and smoking status. Prevalence increased among both women (7.4 percent to 7.6 percent) and men (5.5 percent to 6.0 percent) and among all ethnic groups including whites (5.9 percent to 6.2 percent), blacks (8.9 percent to 9.9 percent), Hispanics (7.7 percent to 8.0 percent) and all others (6.6 percent to 7.7 percent). Approximately 800,000 new cases of diabetes are diagnosed each year. It is the seventh leading cause of death in this country and a major contributor to serious health problems such as heart disease, stroke, blindness, high blood pressure, kidney disease, and amputations. When the long-term complications of this disease and their costs are considered, the implications of these statistics are sobering.

The importance of blood glucose control in preventing microvascular complications of DM, such as retinopathy and nephropathy, is now recognized. The American Diabetes Association's recommended targets for glycemic control include a preprandial blood glucose level of 80 to 120 mg/dL (4.4 to 6.7 mmol/L), a bedtime blood glucose level of 100 to 140 mg/dL (5.6 to 7.8 mmol/L), and an HbA1c level of less than 7%. More stringent guidelines have recently been offered by the American College of Endocrinology and the American Association of Clinical Endocrinologists: preprandial blood glucose levels less than 110 mg/dL (6.1 mmol/L), 2-hour postprandial glucose levels less than 140 mg/dL (7.8 mmol/L), and HbA1c levels at 6.5%. These recommendations are based on findings from 3 landmark studies: the Diabetes Control and Complications Trial, the Kumamoto Study, and the United Kingdom Prospective Diabetes Study (UKPDS), which have shown unequivocally that maintaining blood glucose concentrations as close to normal as possible in both type 1 and type 2 DM decreases the incidence of microvascular complications. Whether such a relationship exists for macrovascular complications, such as myocardial infarction and stroke, is less clear.

About thirty percent of patients with insulin- or non-insulin-dependent diabetes have delayed gastric emptying (diabetic gastroparesis). Some of them complain of epigastric pain, nausea, vomiting or postprandial fullness (diabetic dyspepsia), although only a minority are severely symptomatic. The clinical situation is further complicated by the overlap of symptoms of gastroparesis with those of functional bowel disorders, such as nonulcer dyspepsia (NUD) and irritable bowel syndrome (IBS).

Diabetic gastroparesis is clinically relevant not only by virtue of the symptoms induced but also because it may contribute to inadequate glycemic control and impaired absorption of orally administered drugs. Recent data suggest that abnormal blood glucose control, not only autonomic neuropathy, contribute to the pathogenesis of disordered gastric motility. In most cases, diabetic gastroparesis is diagnosed clinically in the absence of demonstrable lesions of the upper gastrointestinal tract.

The “gold standard” method of measuring gastric emptying time is scintigraphy. A solid or semi-solid meal may be used. This technique allows normal feedback regulation to occur during the test period. A blood glucose concentration should be obtained at the time of the test. The test involves the exposure to a radiation dose. The use of scintigraphy is very expensive (about $1,000 per evaluation) and consequently the clinical use is rare. The combination of expense and radiation exposure makes this test impractical for the serial assessment of gastric performance.

MED Foundation is supporting research in cooperation with the Western Research Company (a company with a long history of successful projects funded by the National Institutes of Health from Tucson Arizona) in the development of an economical, noninvasive test for the evaluation and diagnosis of gastroparesis. The goal is to develop a test that is practical and affordable that can then be accessible to all diabetic sufferers.