bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical Efficacy of Fidarestat, a Novel Aldose Reductase Inhibitor, for Diabetic Peripheral Neuropathy
Authors: Hotta Nigishi , Toyota Takayoshi , Matsuoka Kempei , Shigeta Yukio , Kikkawa Ryuichi , Kaneko Toshio , Takahashi Akira , Sugimura Kimiya , Koike Yasuo , Ishii Jun , Sakamoto Nobuo ,   The SNK-860 Diabetic Neuropathy Study Group
Published: March 2007

OBJECTIVE—The purpose of this study was to evaluate the efficacy of fidarestat, a novel aldose reductase (AR) inhibitor, in a double-blind placebo controlled study in patients with type 1 and type 2 diabetes and associated peripheral neuropathy.
RESEARCH DESIGN AND METHODS—A total of 279 patients with diabetic neuropathy were treated with placebo or fidarestat at a daily dose of 1 mg for 52 weeks. The efficacy evaluation was based on change in electrophysiological measurements of median and tibial motor nerve conduction velocity, F-wave minimum latency, F-wave conduction velocity (FCV), and median sensory nerve conduction velocity (forearm and distal), as well as an assessment of subjective symptoms.
RESULTS—Over the course of the study, five of the eight electrophysiological measures assessed showed significant improvement from baseline in the fidarestat-treated group, whereas no measure showed significant deterioration. In contrast, in the placebo group, no electrophysiological measure was improved, and one measure significantly deteriorated (i.e., median nerve FCV). At the study conclusion, the fidarestat-treated group was significantly improved compared with the placebo group in two electrophysiological measures (i.e., median nerve FCV and minimal latency). Subjective symptoms (including numbness, spontaneous pain, sensation of rigidity, paresthesia in the sole upon walking, heaviness in the foot, and hypesthesia) benefited from fidarestat treatment, and all were significantly improved in the treated versus placebo group at the study conclusion. At the dose used, fidarestat was well tolerated, with an adverse event profile that did not significantly differ from that seen in the placebo group.
CONCLUSIONS—The effects of fidarestat-treatment on nerve conduction and the subjective symptoms of diabetic neuropathy provide evidence that this treatment alters the progression of diabetic neuropathy.
The Effect of Evening Alcohol Consumption on Next-Morning Glucose Control in Type 1 Diabetes
Authors: Turner Benjamin C. , Jenkins Emma , Kerr David , Sherwin Robert S. , Cavan David A. 
Published: March 2007

OBJECTIVE—Alcohol is associated with acute hypoglycemia in patients with type 1 diabetes. After drinking alcohol in the evening, delayed hypoglycemia has also been described, although its cause is unknown. We performed a controlled study to investigate this phenomenon.
RESEARCH DESIGN AND METHODS—We admitted six men with type 1 diabetes (aged 19–51 years, HbA1c 7.0–10.3%) on two occasions, from 5:00 p.m. to 12:00 noon the following day. They received regular insulin injections before standardized meals, at 6:00 p.m. and 8:00 a.m., and a basal insulin infusion (0.15 mU · kg−1 · min−1) from 11:00 p.m. They drank either dry white wine (0.75 g/kg alcohol) or mineral water at 9:00 p.m. over 90 min. Blood glucose, alcohol, insulin, cortisol, growth hormone, and glucagon levels were measured.
RESULTS—Blood ethanol reached a mean (SEM) peak of 19.1 (1.2) mmol/l and was undetectable by 8:00 a.m. There were no significant differences in evening or overnight blood glucose levels between the studies. In the morning, fasting and postprandial blood glucose levels were significantly lower after consumption of wine (postprandial peak 8.9 [1.7] vs. 15 [1.5] mmol/l, P &lt; 0.01), and from 10:00 a.m., five subjects required treatment for hypoglycemia (nadir 1.9–2.9 mmol/l). None of the subjects had hypoglycemia after consumption of water. After consumption of wine, growth hormone secretion was significantly reduced between midnight and 4:00 a.m. (area under the curve 2.1 [1.1] vs. 6.5 [2.1] μg · l–1 · h–1, P = 0.04). There were no differences in insulin or other hormone levels.
CONCLUSIONS—In type 1 diabetes, moderate consumption of alcohol in the evening may predispose patients to hypoglycemia after breakfast the next morning. This is associated with reduced nocturnal growth hormone secretion. Patients should be informed of this risk and advised regarding appropriate preventative measures.
Projection of Diabetes Burden Through 2050
Authors: Boyle James P. , Honeycutt Amanda A. , Narayan K.M. Venkat , Hoerger Thomas J. , Geiss Linda S. , Chen Hong , Thompson Theodore J. 
Published: March 2007

OBJECTIVE—To project the number of people with diagnosed diabetes in the U.S. through 2050, accounting for changing demography and diabetes prevalence rates.
RESEARCH DESIGN AND METHODS—We combined age-, sex-, and race-specific diagnosed diabetes prevalence rates—predicted from 1980–1998 trends in prevalence data from the National Health Interview Survey—with Bureau of Census population demographic projections. Sensitivity analyses were performed by varying both prevalence rate and population projections.
RESULTS—The number of Americans with diagnosed diabetes is projected to increase 165%, from 11 million in 2000 (prevalence of 4.0%) to 29 million in 2050 (prevalence of 7.2%). The largest percent increase in diagnosed diabetes will be among those aged ≥75 years (+271% in women and +437% in men). The fastest growing ethnic group with diagnosed diabetes is expected to be black males (+363% from 2000–2050), with black females (+217%), white males (+148%), and white females (+107%) following. Of the projected 18 million increase in the number of cases of diabetes in 2050, 37% are due to changes in demographic composition, 27% are due to population growth, and 36% are due to increasing prevalence rates.
CONCLUSIONS—If recent trends in diabetes prevalence rates continue linearly over the next 50 years, future changes in the size and demographic characteristics of the U.S. population will lead to dramatic increases in the number of Americans with diagnosed diabetes.
Effects of Sibutramine in Obese Female Subjects With Type 2 Diabetes and Poor Blood Glucose Control
Authors: Gokcel Adnan , Karakose Hatice , Ertorer Eda Melek , Tanaci Nedret , Tutuncu Neslihan Bascil , Guvener Nilgun 
Published: March 2007

OBJECTIVE—In this study, we evaluated the efficacy of sibutramine in combination with hypoglycemic drugs in obese type 2 diabetic women whose glucose levels were poorly regulated.
RESEARCH DESIGN AND METHODS—Female patients with type 2 diabetes, poorly controlled glucose levels, and HbA1c &gt;8% were randomly assigned to one of two groups. In addition to their prescribed hypoglycemic agents (maximum doses of sulfonylureas and metformin), one group (n = 30) received a placebo twice daily for 6 months and the other (n = 30) received sibutramine 10 mg b.i.d. for the same period.
RESULTS—One patient in the sibutramine group was excluded during the study period because of hypertension; thus, a total of 29 data sets were analyzed for this group. In the placebo group, five patients had to be excluded because of low treatment efficacy, leaving a total of 25 who completed the study. Comparing the changes that occurred over 6 months in the sibutramine and placebo groups, the former showed significantly greater reductions in fasting blood glucose (P &lt; 0.0001), second-hour postprandial blood glucose (P &lt; 0.0001), insulin resistance (P &lt; 0.0001), waist circumference (P &lt; 0.0001), BMI (P &lt; 0.0001), HbA1c (P &lt; 0.0001), diastolic blood pressure, pulse rate, uric acid levels, and all elements of the lipid profile except HDL cholesterol and apolipoprotein A1.
CONCLUSIONS—The addition of sibutramine to oral hypoglycemic therapy resulted in significant weight loss and improvement in metabolic parameters in this patient group. Sibutramine is an effective adjunct to oral hypoglycemic therapy in obese women with type 2 diabetes.
Reduced Cardiovascular Morbidity and Mortality in Hypertensive Diabetic Patients on First-Line Therapy With an ACE Inhibitor Compared With a Diuretic/β-Blocker–Based Treatment Regimen
Authors: Niskanen Leo , Hedner Thomas , Hansson Lennart , Lanke Jan , Niklason Anders ,   for the CAPPP study group
Published: March 2007

OBJECTIVE—The Captopril Prevention Project (CAPPP) evaluated the effects of an ACE inhibitor–based therapeutic regimen on cardiovascular mortality and morbidity in hypertension. One planned subanalysis of the CAPPP was to evaluate the outcome in the diabetic patient group.
RESEARCH DESIGN AND METHODS—In the CAPPP, 572 (4.9% of 10,985 hypertensive patients) had diabetes at baseline and were studied according to a prospective, randomized, open, blinded, end point trial design. Patients aged 25–66 years with diastolic blood pressure ≥100 mmHg were included and randomized to receive either captopril or conventional antihypertensive treatment (diuretics and/or β-blockers).
RESULTS—The primary end point, fatal and nonfatal myocardial infarction and stroke as well as other cardiovascular deaths, was markedly lower in the captopril than in the conventional therapy group (relative risk [RR] = 0.59; P = 0.018). Specifically, cardiovascular mortality, defined as fatal stroke and myocardial infarction, sudden death, and other cardiovascular death, tended to be lower in the captopril group (RR = 0.48; P = 0.084), and no difference was observed between the study groups for stroke (RR = 1.02; P = 0.96). Myocardial infarctions were less frequent in the captopril group than in the conventional therapy group (RR = 0.34; P = 0.002). Furthermore, total mortality was lower in the captopril as compared with the conventional therapy group (RR = 0.54; P = 0.034). Patients with impaired metabolic control seemed to benefit the most from ACE inhibitor–based therapy.
CONCLUSIONS—Captopril is superior to a diuretic/β-blocker antihypertensive treatment regimen in preventing cardiovascular events in hypertensive diabetic patients, especially in those with metabolic decompensation.
Rapid Progression of Albumin Excretion Is an Independent Predictor of Cardiovascular Mortality in Patients With Type 2 Diabetes and Microalbuminuria
Authors: Spoelstra-de Man Angélique M.E. , Brouwer Catherine B. , Stehouwer Coen D.A. , Smulders Yvo M. 
Published: March 2007

OBJECTIVE—In patients with type 2 diabetes, microalbuminuria is associated with an increase in predominantly cardiovascular mortality. Considerable interindividual variability in the rate of progression of microalbuminuria exists. The prognostic significance of rate of progression of microalbuminuria with regard to cardiovascular and renal clinical end points is, however, unknown. The purpose of this study was to determine the prognostic significance of rate of progression of microalbuminuria for cardiovascular end points and renal function.
RESEARCH DESIGN AND METHODS—In a previous prospective cohort study, progression of microalbuminuria (expressed as mean yearly change in albumin-to-creatinine ratio) was assessed in 58 patients with type 2 diabetes. During a median follow-up of 7 years after progression of microalbuminuria was determined, we registered all-cause mortality and coronary heart disease mortality as primary end points and coronary heart disease (fatal or nonfatal), peripheral vascular disease, ischemic stroke, retinopathy, macroalbuminuria, and change in serum creatinine as secondary end points.
RESULTS—Seven subjects died during the study; five of these subjects died of coronary heart disease. Cox’s regression analysis identified progression of microalbuminuria as a significant predictor of all-cause mortality (hazard ratio 1.46 per point increase in albumin-to-creatinine ratio per year, P &lt; 0.001), coronary heart disease mortality (hazard ratio 2.32, P = 0.006), and macroalbuminuria (hazard ratio 1.79, P &lt; 0.001). Adjustment for multiple cardiovascular risk factors did not affect these results. Identical analyses for baseline level of microalbuminuria instead of progression rate of microalbuminuria did not show significant hazard ratios. In addition, progression of microalbuminuria significantly predicted an increase in serum creatinine (r = 0.29, P = 0.04).
CONCLUSIONS—In patients with type 2 diabetes and microalbuminuria, the rate of progression of albumin excretion seems to be a powerful independent predictor of mortality caused mainly by coronary heart disease.
A Foot Care Program for Diabetic Unilateral Lower-Limb Amputees
Authors: Carrington Anne L. , Abbott Caroline A. , Griffiths Joan , Jackson Nicky , Johnson Sylvia R. , Kulkarni Jai , Van Ross Ernest R.E. , Boulton Andrew J.M. 
Published: March 2007

OBJECTIVE— To assess the efficacy of a specialist foot care program designed to prevent a second amputation and to assess peripheral vascular disease (PVD) and peripheral neuropathy in diabetic unilateral lower-limb amputees.
RESEARCH DESIGN AND METHODS— Investigations were carried out in 143 diabetic lower-limb unilateral amputees referred to a subregional rehabilitation center for prosthetic care from a catchment area of ∼3 million people. Peripheral vascular and nerve assessment, education, and podiatry were provided for each patient.
RESULTS— For the patients referred to the foot care program,there were no baseline differences between the patients who proceeded to a bilateral amputation (n = 22) and those who remained as unilateral amputees (n = 121) in their level of foot care knowledge and mean neuropathy scores. Mean ankle-brachial pressure index was significantly lower for the bilateral amputees (0.75 ± 0.04) compared with the unilateral amputees (0.90 ± 0.03, mean ± SEM, P &lt; 0.05), but there was no difference in the level of oxygen in the skin. However, the level of carbon dioxide was significantly lower in patients with bilateral amputation (24.21 ± 2.16 vs. 31.20 ± 0.85 mmHg, P &lt;0.03). Overall, the establishment of a specialist foot care program made no impact on contralateral limb amputation (22 of 143, 15.4%) compared with matched patients without the program (21 of 148, 14%) over a 2-year outcome period for each patient.
CONCLUSIONS— PVD is more closely associated with diabetic bilateral amputation than neuropathy or level of foot care knowledge. Preventative foot care programs for diabetic unilateral amputees should therefore place greater emphasis on peripheral vascular assessment to identify patients at risk and on the development of timely intervention strategies.
Factors Influencing Glycemic Control in Young People With Type 1 Diabetes in Scotland
Authors:   Scottish Study Group for the Care of the Young Diabetic
Published: March 2007

OBJECTIVE— To evaluate differences in HbAlcconcentrations between centers and to assess the factors associated with glycemic control in young people with type 1 diabetes in Scotland.
RESEARCH DESIGN AND METHODS— Data on 1,755 patients (94% of those registered) were collected from 18 centers providing care to children&lt;15 years of age. At every clinic visit, a duplicate HbAlcsample was measured in a reference laboratory, and clinical information was collected prospectively.
RESULTS— Average HbAlc concentration was 9.1%(range 5.0-15.0). The following significant associations with HbAlclevel were identified: age, insulin regimen, BMI, season, social circumstances, and family history. HbAlc concentrations were significantly worse in older children (age 10-15 years 9.5% vs. other ages 8.8%, P &lt; 0.001), those using two injections per day (2/day 9.1%vs. 3/day 8.8%, P &lt; 0.01), children without both parents at home(9.4 vs. 9.0%, P &lt; 0.001), a sibling with diabetes (9.7% vs. no family history 9.1%, P &lt; 0.001). HbAlc concentration ranged from 8.1 to 10.2% between centers, after adjustment for factors associated with poor HbAlc (P &lt; 0.001).
CONCLUSIONS— The overall glycemic control of diabetic young people in Scotland is equivalent to a Diabetes Control and Complications Trial HbAlc concentration of 8.7%, placing the majority at a high risk of the complications of diabetes in adulthood. Although factors were significantly associated with poor HbAlc, adjustment for these did not explain the differences between centers. We suggest that factors not analyzed in DIABAUD2 (e.g., deployment of resources, organization of the clinical structure, strategies of care, and clinic philosophy) are the determinants of HbAlc. We speculate that the style of utilization of optimum resources is the key to achieving good glycemic control.
Comparison of the Soluble Basal Insulin Analog Insulin Detemir With NPH Insulin
Authors: Hermansen Kjeld , Madsbad Sten , Perrild Hans , Kristensen Allan , Axelsen Mads 
Published: March 2007

OBJECTIVE— Insulin detemir (NN304) is a soluble basal insulin analog developed to cover basal insulin requirements. This trial aimed to compare the blood glucose—lowering effect of insulin detemir with that of NPH insulin (NPH) and to evaluate the two treatments with regard to intrasubject variation of fasting blood glucose, incidence of hypoglycemia,dose requirements, and safety.
RESEARCH DESIGN AND METHODS— This multicenter open randomized crossover trial in 59 type 1 diabetic subjects comprised a 2-week run-in period on a basal-bolus regimen with NPH insulin once daily, followed by two 6-week periods of optimized basal-bolus therapy with either once-daily insulin detemir or NPH insulin.
RESULTS— The area under the curve, in the time interval 23:00-8:00, derived from 24-h serum glucose profiles, was not statistically significantly different for the two treatment periods (insulin detemir:NPH ratio 89.2:83.5, P = 0.59). The intrasubject variation in fasting blood glucose during the last 4 days of treatment was lower for insulin detemir compared with NPH (P &lt; 0.001). Mean dose requirements of insulin detemir were 2.35 times higher (95% CI 2.22-2.48) compared with NPH. During the last week of treatment, fewer subjects experienced hypoglycemic episodes on insulin detemir (60%) compared with NPH treatment (77%)(P = 0.049).
CONCLUSIONS— Insulin detemir was as effective as NPH in maintaining glycemic control when administered at a higher molar dose. The results indicate that insulin detemir may provide more predictable fasting blood glucose with lower intrasubject variation and reduced risk of hypoglycemia compared with NPH.
Relationship Between Plasma Sialic Acid Concentration and Microvascular and Macrovascular Complications in Type 1 Diabetes
Authors: Crook Martin A. , Pickup John C. , Lumb Peter J. , Georgino Francesco , Webb David J. , Fuller John H. ,   The EURODIAB IDDM Complications Study Group
Published: March 2007

OBJECTIVE— To test the hypothesis that an increased plasma concentration of sialic acid, a marker of the acute-phase response, is related to the presence of diabetic micro- and macrovascular complications in type 1 diabetes.
RESEARCH DESIGN AND METHODS— We investigated the relationship between plasma sialic acid concentration and nephropathy, retinopathy,neuropathy, and coronary heart disease (CHD) in a cross-sectional survey of 1,369 people with type 1 diabetes. Subjects were participants in the EURODIAB IDDM Complications Study, which involved 31 centers in 16 European countries.
RESULTS— There was a significantly increasing trend of plasma sialic acid with severity of retinopathy (P &lt; 0.001 in men) and with degree of urinary albumin excretion (P &lt; 0.001 men, P &lt; 0.01 women). Plasma sialic acid correlated with increasing plasma creatinine concentration (P &lt; 0.009 men, P &lt;0.0002 women), and men with neuropathy had a higher plasma sialic acid concentration than those without (P &lt; 0.006). There was no significant correlation between plasma sialic acid and CHD in either sex. Elevated plasma sialic acid concentrations were also associated with several risk factors for diabetic vascular disease: diabetes duration,HbAlc, plasma triglyceride and cholesterol concentrations,waist-to-hip ratio, hypertension and smoking (in men), and low physical exercise (in women). In multiple logistic regression analysis, plasma sialic acid was independently related to proliferative retinopathy and urinary albumin excretion rate in men.
CONCLUSIONS— We conclude that an elevated plasma sialic concentration is strongly related to the presence of microvascular complications in type 1 diabetes, especially retinopathy and nephropathy. Further study of acute-phase response markers and mediators as indicators or predictors of diabetic microvascular complications is therefore justified.
Contribution of Nerve-Axon Reflex-Related Vasodilation to the Total Skin Vasodilation in Diabetic Patients With and Without Neuropathy
Authors: Hamdy Osama , Abou-Elenin Karim , LoGerfo Frank W. , Horton Edward S. , Veves Aristidis 
Published: March 2007

OBJECTIVE— To examine the contribution of nerve-axon reflex-related vasodilation to total acetylcholine-induced vasodilation in the skin of normal and diabetic subjects.RESEARCH DESIGN AND METHODS— The skin microcirculation was evaluated at the forearm level in 69 healthy subjects and 42 nonneuropathic diabetic patients and at the foot level in 27 healthy subjects and 101 diabetic patients (33 with neuropathy, 23 with Charcot arthropathy, 32 with peripheral vascular disease and neuropathy, and 13 without complications). Two single-point laser probes were used to measure total and neurovascular vasodilation response to the iontophoresis of 1% acetylcholine, 1% sodium nitroprusside, and deionized water.RESULTS— The neurovascular response to acetylcholine was significantly higher than the response to sodium nitroprusside and deionized water (P &lt; 0.01). At the forearm level, the contribution of neurovascular response to the total response to acetylcholine was 35% in diabetic patients and 31% in control subjects. At the foot level, the contribution was 29% in diabetic patients without neuropathy and 36% in control subjects, while it was significantly diminished in the three neuropathic groups. A significantly lower nonspecific nerve-axon-related vasodilation was observed during the iontophoresis of sodium nitroprusside,which does not specifically stimulate the C nociceptive fibers.CONCLUSIONS— Neurovascular vasodilation accounts for approximately one-third of the total acetylcholine-induced vasodilation at both the forearm and foot levels. The presence of diabetic neuropathy results in reduction of both the total vasodilatory response to acetylcholine and the percentage contribution of neurovascular vasodilation to the total response. Acetylcholine and sodium nitroprusside cause vasodilation in the skin microcirculation through different pathways.