Gyula Tamás

Effect of valsartan on the incidence of diabetes and cardiovascular events

BACKGROUND It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. METHODS In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of 5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization for unstable angina; and a core composite outcome that excluded unstable angina and revascularization. RESULTS The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group (hazard ratio in the valsartan group, 0.86; 95% confidence interval [CI], 0.80 to 0.92; P<0.001). Valsartan, as compared with placebo, did not significantly reduce the incidence of either the extended cardiovascular outcome (14.5% vs. 14.8%; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.43) or the core cardiovascular outcome (8.1% vs. 8.1%; hazard ratio, 0.99; 95% CI, 0.86 to 1.14; P=0.85). CONCLUSIONS Among patients with impaired glucose tolerance and cardiovascular disease or risk factors, the use of valsartan for 5 years, along with lifestyle modification, led to a relative reduction of 14% in the incidence of diabetes but did not reduce the rate of cardiovascular events. (ClinicalTrials.gov number, NCT00097786.)

Effect of nateglinide on the incidence of diabetes and cardiovascular events

BACKGROUND The ability of short-acting insulin secretagogues to reduce the risk of diabetes or cardiovascular events in people with impaired glucose tolerance is unknown. METHODS In a double-blind, randomized clinical trial, we assigned 9306 participants with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors to receive nateglinide (up to 60 mg three times daily) or placebo, in a 2-by-2 factorial design with valsartan or placebo, in addition to participation in a lifestyle modification program. We followed the participants for a median of 5.0 years for incident diabetes (and a median of 6.5 years for vital status). We evaluated the effect of nateglinide on the occurrence of three coprimary outcomes: the development of diabetes; a core cardiovascular outcome that was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure; and an extended cardiovascular outcome that was a composite of the individual components of the core composite cardiovascular outcome, hospitalization for unstable angina, or arterial revascularization. RESULTS After adjustment for multiple testing, nateglinide, as compared with placebo, did not significantly reduce the cumulative incidence of diabetes (36% and 34%, respectively; hazard ratio, 1.07; 95% confidence interval [CI], 1.00 to 1.15; P=0.05), the core composite cardiovascular outcome (7.9% and 8.3%, respectively; hazard ratio, 0.94, 95% CI, 0.82 to 1.09; P=0.43), or the extended composite cardiovascular outcome (14.2% and 15.2%, respectively; hazard ratio, 0.93, 95% CI, 0.83 to 1.03; P=0.16). Nateglinide did, however, increase the risk of hypoglycemia. CONCLUSIONS Among persons with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors, assignment to nateglinide for 5 years did not reduce the incidence of diabetes or the coprimary composite cardiovascular outcomes. (ClinicalTrials.gov number, NCT00097786.)

Carbohydrate metabolism and cardiovascular risk factors 4 years after a pregnancy complicated by gestational diabetes

AIMS The aim of the present study was to determine the prevalence of abnormal glucose tolerance and the metabolic syndrome in a cohort of previously gestational diabetic (GDM) women 4 years after delivery. METHODS Sixty-eight prior GDM and a control group of 39 women with normal glucose tolerance during pregnancy were invited to participate in a follow-up study. RESULTS The prevalence of diabetes, impaired glucose tolerance and impaired fasting glucose (IFG) was 21%, 16%, and 6% among prior GDM women and 0%, 15%, and 0% among controls respectively (P=0.0039). Independently of the metabolic syndrome criteria used this status was found more frequently among women with prior GDM (all P<0.05). The prevalence of the metabolic syndrome showed a dose-response relationship with the level of weight categories (P<0.005) as well as with the level of glucose intolerance (P=0.024). CONCLUSION According to our results a disturbed carbohydrate metabolism and a clustering of cardiovascular risk factors might be observed in previous GDM women 4 years after delivery.

Autonomic Neuropathy in Newly Diagnosed Diabetes Mellitus

Two papers in the July 1992 issue of Diabetes Care (1,2) discuss neuropathy in patients with newly diagnosed diabetes. Recently, severe earlyonset polyneuropathy has been reported in IDDM (3). We examined autonomic function in 50 newly diagnosed diabetic patients in four groups: 21 had IDDM (group 1), 14 had NIDDM (group 2), 10 had GDM (group 3; 9 of the patients had NIDDM on retyping after delivery), 5 newly diagnosed diabetic patients (group 4) had chronic alcoholic liver disease, another risk factor for autonomic failure (4). We evaluated heart rate responses to deep breathing, Valsalva maneuver, and standing up, and blood pressure responses to standing up and sustained handgrip (5,6). Cardiovascular reflex testing was performed within 10 days after diabetes diagnosis in groups 1, 2, and 4 and in the period starting insulin therapy in group 3.

Effect of somatostatin on the pancreatitis-like biochemical changes due to endoscopic pancreatography: preliminary report.

Abstract Endoscopic retrograde cholangiopancreatography (ERCP) may cause severe, occasionally lethal, acute pancreatitis. Fortunately, this is a rare complication. However, pancreatitis-like abnormalities associated with increased blood amylase and lipase activity are frequently encountered. 1–5 Attempts t to ameliorate or prevent the enzyme abnormalities accompanying pancreatography, e.g., by aprotinin or glucagon, have been so far unsuccessful. 6 Somatostatin is known to inhibit the endocrine function of the pancreas, i.e., the release of insulin and glucagon. Recently, somatostatin has been demonstrated to also block the exocrine activity of the pancreas and to be of value in a few cases of acute pancreatitis. 7–10 Based on these reports, it seemed worth investigating the effect of the simultaneous administration of somatostatin on the pancreatitis-like biochemical abnormalities accompanying ERCP.

Studies of dental and oral changes of pregnant diabetic women

SummaryThe longitudinal examination of 132 pregnant diabetic women under care showed a 96.2% prevalence of gingivitis. The intensity of gingivitis was most marked in weeks 11 to 15, and 24 to 26 of pregnancy, and the correlation with changes in oral hygiene was statistically significant (p<0.001). On the other hand, the severity of diabetes had no effect on the degree of gingival inflammation. As for caries, the mean DMF values increased during diabetic pregnancy, the number of carious (D) and filled (F) teeth to a higher, that of extracted (M) teeth to a lesser degree, than in diabetic non-pregnant women.

Autonomic Neuropathy and Corrected QT Interval Prolongation: There is a relationship

poorly controlled insulin-dependent diabetes mellitus (IDDM) (1,2). Many drugs have been suggested as active treatment (clonidine, somatostatine, loperamide, calcium-channel blockers, intestinal antibiotics, tricyclic antidepressants, and anticholinergic agents), but clinical responses are often unsatisfactory, and diarrhea (with incontinence) may last for days or weeks despite medical efforts. Here we describe the case of a 48-year-old man, who has suffered from IDDM since he was 21. His HbAlc ranged from 8.4 to 9.3% over the last 12 months, even though he was on multiple insulin injection therapy. His diabetes complications included background retinopathy, impotence, and peripheral and autonomic neuropathy (which was diagnosed through electromyogram and cardiovascular tests). Some months ago, he presented with several episodes of incontinence and diarrhea, which were treated at separate times with loperamide, rifamixine, verapamil, clonidine, amytriptiline, or anticholinergic drugs, without evidence of clinical relief.

Screening for Idiopathic Hemochromatosis Among Diabetic Patients

levels were normal, as was his fasting C-peptide level. An EEG was normal. The patient was placed in the guardianship of the court and discharged to his grandmothers care. Three months later he was seizure free, remained off insulin, and was doing well. IDDM is so readily recognized that once a child has been assigned this diagnosis it is rarely questioned. The case presented here emphasizes the need for the physician to maintain a degree of skepticism when discrepancies are present between the clinical picture and the assigned diagnosis. Our patients normal HbA1c and easily controlled blood glucose levels on such a small dose of insulin prompted our original suspicions. The entity of Munchausens syndrome by proxy IDDM has not previously been reported. In addition, our patient probably had two distinct unrelated forms of Munchausens by proxy, IDDM and seizures. His mother may also have fictitious diabetes, although this cannot be proved.

Osteoprotegerin Levels in Women With Prior Gestational Diabetes Mellitus

Osteoprotegerin (OPG), an inhibitor of bone resorption, seems to be elevated in patients with diabetes as well as in nondiabetic subjects with cardiovascular disease (1). Following a pregnancy complicated by gestational diabetes mellitus (GDM), women present with an increased prevalence of glucose intolerance and an unfavorable cardiovascular risk profile, although definite cardiovascular diseases or late diabetes complications have only rarely been confirmed (2). Hence, our aim was to study OPG levels and their association with other cardiovascular risk factors in a sample of 30 former GDM (by World Health Organization criteria) and 14 age-matched women with normal glucose tolerance during pregnancy in an average 4 years after delivery. During the study investigation an assisted questionnaire was completed, followed by a detailed physical examination, …

Management of diabetics with the use of a microprocessor: Comparison of insulin treatments based on blood and urine glucose levels

SummaryThe insulin treatment of 8 insulin-dependend diabetics was controlled with a microprocessor (Better Control Medical Computer, BCMC, Inc., Toronto, Canada) with information derived from blood or first voided urine glucose concentrations assessed by reagent strips four times a day, before the three main meals and bedtime snack. The microprocessor recommends modification of the insulin doses so as to reach a pre-prandial blood glucose value of 110 mg/dl or a urine glucose concentration of 0.1 g/dl. During the first two weeks self-management was uniformly applied by the patients, based on their blood glucose concentration. Subsequently, it was continued by the patients who were divided into two groups, one using the blood, the other the urine glucose concentrations, each for three weeks, alternately. During microprocessor treatment the patients’ mean blood glucose profiles decreased from 152±37 mg/dl to 126±28 mg/dl. No difference was found between treatments based on blood or urine glucose concentrations concerning either the mean blood glucose profiles or the number of hypoglycemic episodes in the presence of an average glucose threshold and good renal function. The first voided urine glucose concentration and mean and maximal blood glucose values obtained at the time of urine filtration were closely correlated (r=0.82 and 0.86, p<0.001).