Biomedical subjects
Publications and source records attributed to T E Prout.
The pathogenesis of IDDM and NIDDM indicates a distinct difference between these diseases. Viral illness is implicated in IDDM, linked with evidence for an immune deficiency. NIDDM is not linked to viral illness or autoimmunity but is highly influenced by the inheritance of a defect in insulin production.
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Recruitment is never easy, but insurmountable difficulties may arise if this problem is not addressed during the planning phase. Preparation for recruitment must then be started long before the study actually begins. These preparations include building local interest in the participating hospital, visiting local hospitals and medical groups, and informing the general public when feasible. As active recruitment begins, access to the study must be kept open and logistical problems must be solved on a daily basis. Frequent reassessment may demonstrate a failure to maintain goals. Innovative methods for reviving the campaign must then be put in place. Above all, share all successful recruitment methods with others in the study.
Informed consent is vital to the conduct of clinical trials. The evolution of this process is reviewed. In the United States, specific steps must now be taken to assure institutional review bodies that all precautions have been taken to inform patients before they are enrolled in studies. These include (1) the procedure to be followed in the study, (2) the benefits for the individual, (3) the discomforts and risks that are reasonably expected, (4) the alternative methods of therapy, (5) the willingness of the investigator to answer inquiries, and (6) the right to refuse or to withdraw from the study without prejudice. The conditions are discussed in detail.
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A 25-year-old man with systemic sarcoidosis had neovascularization of the optic nerve heads and associated bilateral vitreous hemorrhages. Oral administration of prednisone produced a prompt resolution of these unusual neovascular fronds and cleared the vitreous hemorrhages.
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Plans to recruit patients for a clinical trial must begin early and must utilize a variety of workable techniques if patients are to be acquired at an acceptable rate. Publicity campaigns must be directed toward winning the confidence and good will of the public and of interested physicians.
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In spite of the continuing debate, it is possible to summarize the present state of our knowledge and to draw the following conclusions: 1. Microangiopathy of diabetes can be produced by pure insulin-deficiency in human subjects and experimental animals. 2. Evidence supports the concept that the pathology is due mainly to the deranged metabolism following insulin deprivation. 3. Repair of the insulin deficiency in animals has been shown to prevent the vascular damage associated with insulin deficiency. 4. Present methods of therapy have not been successful in preventing vascular complications in the noninsulin-dependent middle-aged diabetic patient; and, based on the findings of the University Group Diabetes Program, there is reason to believe that new methods of therapy must be realized to improve this outlook. 5. The efficacy of "compulsive control" for prevention of microangiopathy in insulin-dependent diabetic patients has not been adequately studied. Based on the results of animal experiments, the prudent physician should make every attempt to restore a normal physiological cellular environment in these patients with the expectation that this will offer the patient the best opportunity to minimize degenerative complications. Prospective observations are needed on the effects of hypoglycemic episodes which may be inevitable under these circumstances, but there is no evidence at present to suggest that mild hypoglycemia is of itself detrimental. 6. All individuals interested in the prevention of the complications of diabetes using available therapeutic methods should work to encourage a prospective clinical trial carefully designed from both an ethical and scientific point of view to obtain answers to the questions raised here.
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It is frequently difficult to establish a diagnosis of hyperthyroidism in association with pregnancy. Signs and symptoms suggestive of hyperthyroidism may occur in normal pregnancy. Moreover, tests to rule out hyperthyroidism under these conditions are not readily available. Mild hyperthyroidism is not a hazard to an otherwise normal pregnancy and does not require therapy on the basis of this presumption. Hyperthyroidism of a clinically significant degree is safely treatable by medical means without hazard to the fetus. Hyperthyroidism is an uncommon cause for the failure of pregnancy to proceed to term. Treatment with thyroid based on a presumption of this diagnosis is justified, but such patients should be studied carefully after delivery to establish the true state of thyroid function for the future. Other conditions of thyroid dysfunction, including thyroiditis, thyroid carcinoma, nontoxic goiter, and ovarian struma rarely interfere with an otherwise normal pregnancy.
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Glucose tolerance, insulin secretion, and responses to arginine infusion were studied in 17 adults with severe protein-calorie malnutrition (PCM) in Calcutta, India. Patients were selected for the severity of their malnutrition and for absence of other diseases. After 2-4 mo of refeeding there was complete clinical recovery, and control studies were performed. Glucose tolerance, as assessed by intravenous glucose-tolerance test (IVGTT), was reduced in PCM. Insulin response, both to glucose and to arginine infusion, was clearly reduced. The K value of the IVGTT correlated well with the ratio of mean to basal serum insulin during the first 40 min of the test. Basal serum insulin was nearly unchanged in PCM as compared with after recovery, although one patient studied serially showed a temporary drop in basal insulin during the first week of refeeding. In PCM, plasma amino acid levels failed to fall in response to arginine-induced insulin secretion as they did in the control studies. It appears that insulin secretory response is severely reduced in PCM and that a degree of insulin resistance in relation to body weight is present. These changes result in diminished glucose tolerance and probably in a reduced rate of tissue utilization of amino acids. Such alterations may be of adaptive significance in chronic PCM.
The increase in cardiovascularortality associated with the use of oral hypoglycemic agents is emphasized. It is important that clinical pharmacologists take a more positive stand against the use of medications that have added risks that are not offset by actual benefits to the patient.
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