Selected ongoing clinical trials. (Featured CME Topic: Diabetes Mellitus).

Selected ongoing clinical trials (*)

* ACHILLES TENDON LENGTHENING IN PATIENTS WITH DIABETES TO PREVENT FOOT ULCERS.

This Phase I, randomized, prospective, controlled clinical trial will compare the effect of surgery to lengthen the Achilles tendon with the foot in a cast to using a cast alone. It will also examine how foot strength, joint movement, and the overall ability to walk, balance, and climb stairs are affected. Both men and women with a history of diabetes mellitus are eligible.

* ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES (ACCORD).

This factorial design, randomized control study will attempt to prevent major cardiovascular events in type 2 diabetes mellitus patients using intensive glycemic control, intensive lipid and blood pressure control, and insulin resistance-lowering therapy. Both men and women aged 50-75 years with type 2 diabetes mellitus are eligible.

* STUDY OF THE EFFECTS OF VITAMIN C ON PATIENTS WITH TYPE 2 DIABETES.

This Phase II clinical trial will determine the effects of vitamin C on both insulin sensitivity and endothelium function of patients with type 2 diabetes. The study will also determine the effects of vitamin C in patients with vitamin C deficiency. Both men and non-pregnant women between the ages of 18 and 65 years in good general health, except for type 2 diabetes are eligible.

* METHODS FOR MEASURING INSULIN SENSITIVITY

The purpose of this natural history study is to develop better methods for measuring the way body tissue responds to insulin and sugar in patients with high blood pressure, diabetes, and those who are overweight. Both men and women aged 18 to 65 years in good general health, those with hypertension, and diabetic patients are eligible.

* RANDOMIZED TRIAL OF HEALTH EVENTS COSTS IN DIABETIC BLACKS.

This randomized, controlled trial will determine the effects of a nurse case manager/ community health worker team on metabolic control on the occurrence of diabetes-related health events, health care utilization, and on direct health care costs. African American men and women aged 30 years or older who are diagnosed with type 2 diabetes mellitus are eligible.

* NEW DAY: NUTRITION, EXERCISE, WEIGHT LOSS, DIABETES, AND YOU.

This Phase III, multi-disciplinary, behavioral, group-based clinical trial will examine whether the addition of individual sessions of a motivational intervention to a state-of-the-art behavioral group weight loss intervention improves weight loss and glycemic control outcomes in women with type 2 diabetes. Women aged 19 years and older who have a body mass index of 27-50 and type 2 diabetes treated with oral medications are eligible.

* INVESTIGATION OF SUBATMOSPHERIC PRESSURE DRESSING ON PRESSURE ULCER HEALING.

This Phase II, randomized, open label study will: conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing (SPD) in healing pressure ulcers vs conventional saline wet-to-moist dressing techniques; establish indications and contraindications in using SPD to treat pressure ulcers; and develop a noninvasive, clinically usable optical digitizer to measure wound geometry. Both men and women aged 18 years and older with wounds and ulcers are eligible.

* AGING AND CELLULAR MECHANISM FOR INSULIN ACTION AFTER EXERCISE TRAINING.

This randomized, uncontrolled, single-group study will determine whether the metabolic and cellular mechanisms contributing to improved insulin action after aerobic or resistive exercise are different in older, obese, insulin-resistant veterans. Males aged 50 to 80 years that are overweight, are non-smokers, and are sedentary are eligible.

* A CLINICAL TRIAL TO PREVENT THE COMPLICATIONS OF INSULIN RESISTANCE (INCLUDING TYPE-2 DIABETES).

This Phase II, randomized, double-blind, placebo-controlled study will aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood. It will also prevent the subsequent progression towards impaired glucose tolerance and type 2 diabetes. Obese boys and girls aged five years and older are eligible.

* DISEASE MANAGEMENT AND EDUCATIONAL INTERVENTION OUTCOMES IN HIGH-RISK DIABETICS.

This randomized, open-label study will produce reliable and valid data to examine whether interventions of diabetes self-management education programs and the utilization of advanced practice nurse case managers are cost effective, while improving patient and system outcomes. Both men and women who have had a recent [HbA.sub.1c] >9.5 are eligible.

* ISLET TRANSPLANTATION USING STEROID-SPARING IMMUNOSUPPRESSION FOR DIABETES MELLITUS TYPE 1.

This Phase II clinical trial will determine whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy. Both men and women between the ages of 18 and 65 years with type 1 diabetes mellitus are eligible.

* GENETIC STUDIES OF INSULIN AND DIABETES.

This natural history study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of insulin. Both men and women with hyperinsulinernia or a clinical presence of diabetes are eligible.

* GENETIC INFLUENCE ON SUSCEPTIBILITY TO TYPE 1 DIABETES MELLITUS.

This multi-center, natural history study will attempt to explain what makes certain individuals susceptible to type 1 diabetes mellitus, which may lead to the development of improved treatments for the disease. Both men and women aged 18 years and older with type 1 diabetes mellitus and healthy volunteers are eligible.

* INGESTED INTERFERON ALPHA: PROLONGED OR PERMANENCE OF THE "HONEYMOON" PHASE IN NEWLY DIAGNOSED DIABETES MELLITUS.

This Phase II, double-blind, randomized trial will attempt to interfere with the autoimmune beta-cell destruction early on in order to preserve residual endogenous insulin production. Both men and women between the ages of three and 25 years with type 1 diabetes mellitus of less than six weeks in duration are eligible.

* EPIDEMIOLOGY OF HEARING LOSS IN DIABETIC AND NON-DIABETIC VETERANS.

This cross-sectional, random sample study will determine if individuals with diabetes are at an increased risk of hearing impairment or tinnitus. Both men and women aged 21 to 80 years diagnosed with diabetes are eligible.

* ACUTE GLYCEMIC EFFECTS OF A VERY-LOW-FAT DIET IN TYPE 2 DIABETES.

This randomized, single-blind study will gather preliminary information on the effect of a very-low-fat diet on blood metabolism in people with type 2 diabetes. Both men and women aged 45 years and older with type 2 diabetes, not tightly controlled, are eligible.

* DOES ISLET TRANSPLANTATION ELIMINATE HYPOGLYCEMIA?

This non-randomized, single-blind study will determine if islet transplantation will eliminate low blood sugar. Both men and women aged 18 years and older who are clinically stable, insulin dependent islet transplant recipients and nondiabetic healthy individuals are eligible.

* IMPROVING COMPLIANCE WITH METFORMIN.

This is a Phase II, randomized, controlled trial of adherence that will involve monitoring and managing focused intervention in patients taking metformin. Men and women aged 18 years and older who are taking metformin are eligible.

* IMPROVING HEALTH OUTCOMES OF DIABETIC VETERANS: A DIABETIC SELF-MANAGEMENT PROGRAM.

This randomized, open-label study will explore the role of self-efficacy in helping veterans move toward healthy behaviors. Veterans with diabetes who are receiving health care are eligible.

* PROSPECTIVE CONTROLLED STUDY OF POSTTRANSPLANT DIABETES.

This study will determine whether people are predisposed to develop diabetes mellitus after kidney transplantation. Both men and women aged 18 years and older with a fasting plasma glucose of < 126 mg/dL are eligible.

(*.) Prepared by Elaine McClellan-Holm.