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At least 361 records · Page 20Linked to original sources
PubMed2006

[Type 2 diabetes mellitus and health-related quality of life: results from the Hortega Study].

OBJECTIVE: To evaluate which health-related quality of life (HRQOL) aspects are affected by type 2 diabetes mellitus (DM) and influence of glycemic control and associated cardiovascular risk factors (CVRF). METHOD: A descriptive cross-sectional study was carried out in the health coverage area of our hospital. Following a multiphase sampling a final sample of 495 people, representative of the general population, was analyzed. HRQOL was evaluated with the Short-Form 36 (SF-36). RESULTS: After adjustment for sociodemographic variables (age, sex, education level, marital status, number of persons residing together, labor situation, social class and rural or urban ambience), comorbidity and CVRF (smoking, systolic blood pressure, LDL-cholesterol level and body mass index), the patients with DM presented lower scores on four SF-36 scales: physical function, bodily pain, general health and vitality. Among people with diabetes systolic blood pressure, body mass index and glycosylated hemoglobin, but not lipid levels, were negatively correlated to some SF-36 scores. CONCLUSIONS: In our population patients with DM present a poorer HRQOL, specifically in the physical dimensions, but neither their social function nor their mental health was affected. Hypertension, obesity and poor glycemic control are associated with worst subjective state of health.

Aged↗
PubMed2000

Progression of microalbuminuria to proteinuria in type 1 diabetes: nonlinear relationship with hyperglycemia.

While small clinical trials have shown that improved glycemic control reduces the risk of progression of microalbuminuria to proteinuria, two recent clinical trials did not confirm this finding. We sought to reconcile the contradictory evidence by examining the dose-response relationship between hyperglycemia and progression of microalbuminuria to proteinuria in individuals with type 1 diabetes and microalbuminuria (n = 312) who were followed for 4 years with repeated assessments of urinary albumin excretion. Since 33 patients did not participate in follow-up (10.6%), data for 279 patients were analyzed. Urinary albumin excretion level worsened to proteinuria in 40 (4.1 per 100 person-years). To examine the dose-response relationship, baseline HbA1c was divided into four roughly equal groups using the cut points 8, 9, and 10%. The incidence rate varied significantly among the four groups (P = 0.008). Among those with HbA1c <8.0%, the incidence rate of progression was only 1.3 per 100 person-years, while it was 5.1, 4.2, and 6.7 per 100 person-years in the three other groups. We used generalized additive models to examine the dose-response curve using HbA1c as a continuous variable and found that the risk of progression rises steeply between an HbA1c of 7.5-8.5% and then remains approximately constant across higher levels. In conclusion, the results of this study suggest that, in patients with microalbuminuria, the risk of progression to overt proteinuria can be reduced by improved glycemic control only if the HbA1c is maintained below 8.5%. Moreover, below that value, the risk declines as the level of HbA1c decreases.

Adolescent↗
PubMed1995

Diabetes guidelines, outcomes, and cost-effectiveness study: a protocol, prototype, and paradigm.

It is a milestone for our profession to have practice guidelines tested in a clinical trial that also provides cost-effectiveness data. Dietetics practitioners now have a model for studies examining MNT in other disorders and diseases. We also have an array of questions that can be asked in future studies. The challenges include examining the long-term management of diseases using MNT; determining changes in quality-of-life issues; and segmenting subjects according to variables likely to affect outcomes, such as duration of the disease. As a result of this and other studies related to diabetes (both completed and in progress), millions of people with NIDDM will be guided to achieve the best glycemic control possible within the framework of their lifestyles. The results of the DCCT may have implications for persons with NIDDM (18), as well as for dietitians (8). The UK Prospective Diabetes Study results should be released in the near future (19), and the VA Cooperative Study on Glycemic Control and Complications in Type II Diabetes (20) is examining intensive therapy for this population. Each of these studies emphasizes a treatment approach that places management of the disease in the hands of the client. This approach clearly is a paradigm shift: no longer are we talking about "diabetic diets." But then, maybe we just need to read a little history. In 1906, Hutchison (21) wrote," ... there is no such thing as 'a diabetic diet.'" And think about the information (or lack thereof) available to him.

Blood Glucose↗
PubMed2006

Counterregulatory deficits occur within 24 h of a single hypoglycemic episode in conscious, unrestrained, chronically cannulated mice.

Hypoglycemia-induced counterregulatory failure is a dangerous complication of insulin use in diabetes mellitus. Controlled hypoglycemia studies in gene knockout models, which require the use of mice, would aid in identifying causes of defective counterregulation. Because stress can influence counterregulatory hormones and glucose homeostasis, we developed glucose clamps with remote blood sampling in conscious, unrestrained mice. Male C57BL/6 mice implanted with indwelling carotid artery and jugular vein catheters were subjected to 2 h of hyperinsulinemic glucose clamps 24 h apart, with a 6-h fast before each clamp. On day 1, blood glucose was maintained (euglycemia, 178 +/- 4 mg/dl) or decreased to 62 +/- 1 mg/dl (hypoglycemia) by insulin (20 mU x kg(-1) x min(-1)) and variable glucose infusion. Donor blood was continuously infused to replace blood sample volume. Baseline plasma epinephrine (32 +/- 8 pg/ml), corticosterone (16.1 +/- 1.8 microg/dl), and glucagon (35 +/- 3 pg/ml) were unchanged during euglycemia but increased significantly during hypoglycemia, with a glycemic threshold of approximately 80 mg/dl. On day 2, all mice underwent a hypoglycemic clamp (blood glucose, 64 +/- 1 mg/dl). Compared with mice that were euglycemic on day 1, previously hypoglycemic mice had significantly higher glucose requirements and significantly lower plasma glucagon and corticosterone (n = 6/group) on day 2. Epinephrine tended to decrease, although not significantly, in repeatedly hypoglycemic mice. Pre- and post-clamp insulin levels were similar between groups. We conclude that counterregulatory responses to acute and repeated hypoglycemia in unrestrained, chronically cannulated mice reproduce aspects of counterregulation in humans, and that repeated hypoglycemia in mice is a useful model of counterregulatory failure.

Animals↗
PubMed2002

Effect of gender on counterregulatory responses to euglycemic exercise in type 1 diabetes.

A marked sexual dimorphism in neuroendocrine and metabolic responses to moderate, prolonged exercise occurs in healthy humans. It is unknown whether similar differences occur in type 1 diabetes mellitus (T1DM). Fifteen patients with T1DM (7 women and 8 men) were studied during 90 min of euglycemic exercise at 50% of the maximum rate of O(2) consumption. Men and women were matched for age, glycemic control, duration of diabetes, and exercise fitness, and had no history or evidence of autonomic neuropathy. Hypoglycemia was scrupulously avoided during the week preceding tests. Exercise was performed under constant infusion of regular insulin (1 U/h) and a variable 20% dextrose infusion, as needed to maintain euglycemia. At 15-min intervals, neuroendocrine, metabolic (glucose kinetics, intermediate metabolism, lipolysis), and cardiovascular responses were assessed. Indirect calorimetry was performed during the last 10 min of exercise. Plasma glucose and insulin did not differ between genders at baseline or during exercise. Key neuroendocrine responses were significantly reduced in women, compared with men, during exercise (epinephrine, 360 +/- 104 vs. 666 +/- 126 pM; norepinephrine, 2.3 +/- 0.8 vs. 4.1 +/- 1.0 nM; GH, 10 +/- 5 vs. 22 +/- 8 micro g/liter). Glucagon, cortisol, and pancreatic polypeptide responses were similar between genders. Despite reduced catecholamine responses in women, no gender differences were observed in endogenous glucose production (EGP) or exogenous glucose infusion rate during exercise. The lipolytic response to exercise (blood glycerol), on the other hand, was greater in women than in men. In conclusion, a marked sexual dimorphism exists in counterregulatory responses to exercise in T1DM, including key neuroendocrine (catecholamine, GH) and metabolic (lipolysis) responses. Other responses, including glucagon and EGP, were similar between genders, suggesting that the glucagon to insulin ratio may be the primary determinant of EGP during moderate intensity exercise in T1DM.

Adult↗
PubMedDate not supplied

Some engineering aspects of insulin delivery systems.

The characteristics of electronically controlled insulin delivery systems are presented. Early experiments with an external system have shown promise in providing improved glycemic control over conventional methods of single or multiple subcutaneous insulin injections. The encouraging results with external insulin delivery systems have led to the development and early testing in dogs of an implantable system with remote controls to permit variable insulin flow rates. A number of questions remain to be answered before widespread experimentation with external and implanted insulin delivery systems is possible. There appears to be no major development problems with the engineering aspects of such systems.

Animals↗
PubMed1996

[Lipoprotein(a) concentrations in type I diabetes mellitus].

OBJECTIVES: To determine the distribution of lipoprotein(a) levels and prevalence of hyperLp(a) in diabetes mellitus type I (IDDM). To analyze the effect of glycemic control and microalbuminuria on Lp(a) levels. METHODS: Cross-sectional study of 263 subjects with IDDM with a mean age of 19.2 +/- 11.6 years and an evolutive course of 6.3 +/- 6.5 years. Apart from Lp(a), measurements were obtained from serum levels of lipids, apolipoproteins AI and B, fructosamine, glycosilated hemoglobin (HbA1c), and albuminuria in all patients. RESULTS: Mean serum concentrations of Lp(a) were 16.5 +/- 18.1 mg/dl and 18.5% of patients had Lp(a) levels > 30 mg/dl [hyperLp(a)]. With a multivariate regression analysis, the only variable correlated with Lp(a) levels was cholesterol LDL (p < 0.001). Patients with hyperLp(a) did not differ from the other patients in any of the other variables analyzed, and patients with HbA1c higher and lower than 8% had similar mean serum Lp(a) concentrations (14.0 +/- 16 vs. 17.9 +/- 20). Lp(a) concentration was also similar among patients with albuminuria higher and lower than 20 micrograms/min (16.6 +/- 20 vs. 17.7 +/- 16). CONCLUSIONS: Control of glycemia and microalbuminuria have no effect on Lp(a) concentrations in diabetes mellitus type I. HyperLp(a) is not indicative of a poor glycemic control.

Adolescent↗
PubMed2004

[Usefulness of miglitol in patients with diabetes mellitus type 2 and insufficient control of the blood glucose].

OBJECTIVE: Miglitol belongs to the group of the inhibitors of the alpha-glucosidases and in several studies has demonstrated its usefulness in the improvement of the glycemic control in the different types of diabetic patients. The goal of our study was to analyze the usefulness of miglitol in the blood glucose and lipid control in a group of patients with diabetes type 2 treated with sulfonylureas and insulin, with insufficient glycemic control. PATIENTS AND METHODS: A group of 33 patients with diabetes mellitus type 2 treated with sulfonylureas and insulin and with insufficient glycemic control (HbA1c>7.5%) was studied. All patients were treated with miglitol during 3 months with progressive doses: the first week 50 mg twice a day, subsequently and during one month 50 mg three times a day. At the beginning of the study and up to three months the following variables were measured; weight, height, BMI (body mass index), systolic and diastolic blood pressure, HbA1c, number of episodes of peripheral hypoglycemia, basal glucose, albuminuria, total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides, as well as transaminases (GOT, GPT, gamma GT and bilirubin). RESULTS: The median age was 64.1 +/- 12.5 years, and the median length of diabetes mellitus was 9.1 +/- 7 years. The median value of BMI was 27.7 +/- 6.9 kg/cm2. The blood glucose and HbA1c values decreased 4.8% and 5.8%, respectively. A decrease in the number of hypoglycemia episodes (39.4% previous quarter versus 3% quarter wih miglitol) was observed. Also decreased the dose of sulfonylureas needed by the patients (86.2 +/- 24.3 mg/day versus 64.6 +/- 21.9 mg/day; p<0.05) (25%). Total cholesterol, HDL-cholesterol, and LDL-cholesterol levels were not modified, but indeed a reduction of the levels of triglycerides (145.2 +/- 111 mg/dl versus 133.1 +/- 79 mg/dl; p<0.05) (8.3%) was detected. Fifteen percent of patients showed side effects (digestive discomfort) that disappeared two or three weeks after beginning the treatment. CONCLUSIONS: Miglitol is a useful drug in order to improve the glycemic control in diabetic type 2 patients treated previously with other drugs and with insufficient control of the blood glucose. Its side effects are limited and transitory.

1-Deoxynojirimycin↗
PubMed1999

Risk factors for the progression of microalbuminuria in Japanese type 2 diabetic patients--a 10 year follow-up study.

To clarify risk factors for the progression of microalbuminuria in Japanese type 2 diabetic patients, the longitudinal study for 10 years was conducted on 67 outpatients with type 2 diabetes, who had shown no overt proteinuria at baseline. The urinary albumin index (UAI) has been determined based on the mean of at least two random urine samples each year. Categories were defined as normoalbuminuria (UAI < 30.0 mg/g x Cr.), microalbuminuria (30.0 < or = UAI < 300.0), and macroalbuminuria (UAI > or = 300.0). Progression was defined as worsening of the category and/or more than doubling of the baseline UAI value. Multiple logistic regression analysis was performed using age, duration of diabetes, HbA1c, blood pressure, BMI, serum lipids, smoking habits, and alcohol consumption as independent variables and the progression of microalbuminuria as a dependent variable. Age and HbA1c were estimated as significant and independent variables. Furthermore, genetic polymorphisms of angiotensin I-converting enzyme (ACE) and angiotensinogen were analyzed to evaluate the genetic contribution. The D/D genotype of ACE was significantly more common in progressors than in non-progressors. These results suggest that glycemic control and age are important risk factors and the D/D genotype of ACE acts as a risk factor for the progression of microalbuminuria in Japanese type 2 diabetic patients.

Adult↗
PubMedDate not supplied

Near normoglycemia for 1 year has no effect on platelet reactivity, factor VIII, and von Willebrand factor in insulin-dependent diabetes mellitus: a controlled trial.

The impact of prolonged near-normoglycemia on platelet reactivity (spontaneous and induced platelet aggregation), factor VIII, and von Willebrand factor in patients with insulin-dependent diabetes mellitus (IDDM) was evaluated in a prospective, randomized, controlled clinical trial. Twenty IDDM patients with no or only minor clinical signs of microvascular disease were randomly assigned to 1 year of continuous subcutaneous insulin infusion (CSII) or unchanged conventional insulin treatment (CIT). Hemoglobin A1c declined during the 12 month observation period from 7.3 +/- 1.2% to 6.4 +/- 0.9% (2p less than 0.01) in the CSII group, while this measure of glycemic control was unchanged in the CIT group: 7.2 +/- 1.1% vs 8.0 +/- 1.6% (NS). Platelet reactivity, factor VIII, and von Willebrand factor concentrations were identical in the two groups at entry into the study, and no significant changes in these variables were seen in either group. Thus, the present results do not support the concept of increased platelet reactivity following CSII treatment.

Adult↗
PubMed1982

Total implantation of a remotely controlled insulin minipump in a human insulin-dependent diabetic.

This study reports our first total implantation of an insulin minipump in a severely unstable 23-year-old female insulin-dependent diabetic. The implantable unit includes a stepping motor, a percutaneously refillable insulin reservoir (10 ml, U 100 special insulin), a battery with a life span of one year, and a method for prevention of overdosage. Variable continuous basal and superimposed 1-hour high rates are programmed and checked via an external remote controller. The pump was inserted in the lateral muscles of the abdomen and the insulin delivery catheter terminated in the peritoneal cavity. Excellent glycemic control was reached rapidly and has continued seven months after implantation (mean blood glucose is 123 +/- 62 mg/dl; glycosylated hemoglobin is 7.0 +/- 1.2%), with the unit providing the only source of insulin. The only negative aspects were a chronic lymphorrhea in the first two months, and a need for frequent and laborious insulin refills (every 20 days). Only slight local discomfort was experienced. Thus, although further miniaturization and autonomy are expected, these preliminary results show that with careful instruction and followup, implanted pumps could represent a reliable and safe alternative to conventional insulin therapy for selected diabetics.

Adult↗
PubMed2006

Does periodontal care improve glycemic control? The Department of Veterans Affairs Dental Diabetes Study.

OBJECTIVES: Report results of a randomized-clinical trial of the efficacy of periodontal care in the improvement of glycemic control in 165 veterans with poorly controlled diabetes over 4 months. METHODS: Outcomes were change in Haemoglobin A1c (HbA1c) in the Early Treatment versus untreated (Usual Care) groups and percent of participants with decreases in HbA1c. Analyses included simple/multiple variable linear/logistic regressions, adjusted for baseline HbA1c, age, and duration of diabetes. RESULTS: Unadjusted analyses showed no differences between groups. After adjustment for baseline HbA1c, age, and diabetes duration, the mean absolute HbA1c change in the Early Treatment group was -0.65% versus -0.51% in the Usual Care group (p=0.47). Adjusted odds for improvement by 0.5% in the Early Treatment group was 1.67 (95% confidence interval: 0.84, 3.34, p=0.14). Usual Care subjects were twice as likely to increase insulin from baseline to 4 months (20% versus 11%, p=0.12) and less likely to decrease insulin (1% versus 6%, p=0.21) than Early Treatment subjects. Among insulin users at baseline, more increased insulin in the Usual Care group (40% versus 21%, p=0.06). CONCLUSIONS: No significant benefit was found for periodontal therapy after 4 months in this study; trends in some results were in favour of periodontal treatment.

Age Factors↗
PubMedDate not supplied

Computer-assisted insulin dosage adjustment.

We report our first experience with a new microprocessor device for assisting individuals with diabetes in the adjustment of insulin therapy. The computer weighs 200 g and can receive, store, and analyze patient-entered capillary blood glucose (CBG) data on an ongoing basis. Changes in the injected mixtures of short- and intermediate-acting insulins are recommended according to algorithms designed to bring the premeal CBG levels to any desired target value set by the physician. Throughout the present study, the premeal target glucose level was set to 110 mg/dl. Seven (type I) insulin-dependent diabetic individuals ranging in age from 11 to 43 yr were selected to participate in the first use of a BCMC (Better Control Medical Computers, Inc., Toronto, Ontario, Canada) computer on an outpatient basis. All subjects were concerned about diabetes control and were fully informed about as well as thoroughly practiced in the use of manual insulin dosage adjustment schemes, based on approximately equal to 4 times daily CBG estimation, as currently taught in our diabetes clinics. During the last 7 days of the control period of self-adjustment, their mean +/- SEM CBG levels (measured before breakfast, lunch, dinner, and bedtime snack) were, respectively, 178 +/- 20, 187 +/- 35, 208 +/- 22, and 207 +/- 13 mg/dl. Immediately after the control period they were given the device and were instructed in the procedure for entering glycemic data and following manufacturer's recommendations in regard to insulin dosages. This experimental period lasted 8 wk and the outcome was assessed as before. Thus, 8 wk after starting daily use of the instrument, all glycemic values measured as before had fallen significantly (P less than 0.005-0.05) closer to normal: 116 +/- 9, 110 +/- 6, 148 +/- 15, and 135 +/- 9 mg/dl, respectively. Concurrently there was also a significant (P less than 0.01) reduction in the variability of glycemia measured before the main meals.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1992

Effect of improved diabetes control on the expression of lipoprotein lipase in human adipose tissue.

Patients with diabetes commonly manifest hypertriglyceridemia along with decreased adipose tissue lipoprotein lipase (LPL) activity, and improved diabetes control tends to reverse these abnormalities. To better understand the mechanism of regulation of LPL in diabetes, 11 diabetic patients (3 type I, 8 type II) were brought under improved glycemic control, and adipose tissue LPL gene expression was assessed by performing paired fat biopsies. Six of the 11 patients attained improved control with insulin, with a decrease in glycohemoglobin (glyc Hgb) from 13.8 +/- 0.9 to 10.4 +/- 0.6%; 5 patients attained improved control with glyburide (glyc Hgb fell from 14.2 +/- 2.4 to 8.8 +/- 0.6%), and together they demonstrated a lowering of serum triglycerides and total cholesterol. No changes were observed in HDL cholesterol. Improved diabetes control resulted in a significant increase in LPL activity in both the heparin-releasable (HR) and extractable (EXT) fractions of adipose tissue, as well as in LPL immunoreactive mass. The change in LPL activity with improved control was variable, and showed a positive correlation with the HDL levels prior to treatment (r = 0.74, P less than 0.02). When adipose tissue was pulse-labeled with [35S]methionine, there was an increase in isotope incorporation into LPL after treatment, indicating an increase in LPL synthetic rate. However, improved diabetes control resulted in no significant change in LPL mRNA levels. Thus, improved glycemic control resulted in an increase in LPL activity which correlated with each patient's basal high density lipoprotein. This increase in LPL activity was accompanied by an increase in LPL immunoreactive mass, and an increase in LPL synthesis.(ABSTRACT TRUNCATED AT 250 WORDS)

Adipose Tissue↗
PubMed1997

Effect of a bicultural community health worker on completion of diabetes education in a Hispanic population.

OBJECTIVE: To determine the effect of a bicultural community health worker (CHW) on completion of diabetes education in an inner-city Hispanic patient population and to evaluate the impact of completion of the education program on patient knowledge, self-care behaviors, and glycemic control. RESEARCH DESIGN AND METHODS: Patients were randomized into CHW intervention and non-CHW intervention groups. All patients received individualized, comprehensive diabetes education from a certified diabetes nurse educator after baseline demographic information, diabetes knowledge, diabetes self-care practices, and glycohemoglobin levels were assessed. Rates of education program completion were determined. Diabetes knowledge, self-care practices, and glycohemoglobin levels were reassessed at program completion and at a later postprogram follow-up medical appointment and compared to baseline. Logistic regression analysis and the Mantel-Haenszel chi 2 statistic were used to determine the effect of the CHW assignment on program completion. Analyses of covariance were performed with end-of-treatment behavior scores, knowledge scores, and glycohemoglobin levels as outcome variables, controlling for baseline values and testing for the effect of CHW assignment. RESULTS: Of 64 patients enrolled in the study, 40 (63%) completed and 24 (37%) dropped out before completing the diabetes education program. Of the patients having CHW intervention, 80% completed the education program, compared with 47% of patients without CHW intervention (P = 0.01). "Dropouts" were younger (age 47.5 +/- 12.5 years [mean +/- SD]) compared with patients who completed the program (55.9 +/- 9.9 years) (P = 0.004). Dropout status showed no significant relationship to educational level achieved or literacy level. For the program "completers," knowledge levels and selected self-care practices significantly improved, and glycohemoglobin levels improved from a baseline level of 11.7% to 9.9% at program completion (P = 0.004) and 9.5% at the postprogram follow-up (P < 0.001). The effect of the CHW assignment on program completion, controlling for financial status and language spoken, was extremely robust (P = 0.007). The effect of the CHW on knowledge, self-care behavior, or glycohemoglobin outcome variables was not statistically significant. CONCLUSIONS: These findings suggest that intervention with a bicultural CHW improved rates of completion of a diabetes education program in an inner-city Hispanic patient population irrespective of literacy or educational levels attained. Our data further suggests that completion of individualized diabetes educational strategies leads to improved patient knowledge, self-care behaviors, and glycemic control.

Adult↗
PubMed1997

Autonomic neuropathy and cardiovascular risk factors in insulin-dependent and non insulin-dependent diabetes.

In 97 IDDM and 64 NIDDM patients aged under 65 years, we evaluated the relationship between autonomic neuropathy (AN) and retinopathy, nephropathy, glycemic control and cardiovascular risk factors. Diabetes duration and HbA1 were significantly higher and body mass index was significantly lower in IDDM patients with AN compared to those without. In NIDDM only age was significantly higher in neuropathic patients. AN was associated with retinopathy in both IDDM (chi2 = 10, P < 0.03) and NIDDM patients (chi2 = 14, P < 0.007), while only in IDDM albumin excretion was significantly higher in patients with AN. Blood pressure (BP) was significantly higher in both IDDM and NIDDM patients with AN compared to those without. There were no differences in smoking and serum lipids between patients with and those without AN. We performed a multiple regression analysis using autonomic score, index of cardiovascular tests impairment, as the dependent variable and age, diabetes duration, body mass index, HbA1, albumin excretion, cholesterolemia, triglyceridemia, systolic BP, and retinopathy as independent variables. With this model in IDDM autonomic score was only related to body mass index (r = -0.29, P < 0.05), to HbA1 (r = 0.46, P < 0.001), and to systolic BP (r = 0.24, P < 0.05), while in NIDDM it was only related to systolic BP (r = 0.54, P < 0.001). In conclusion, AN was related to age in NIDDM, and to diabetes duration and glycemic control in IDDM. AN was associated with retinopathy, with nephropathy (only in IDDM), and with BP levels, but not with dyslipidemia, smoking, or obesity. Excess mortality rate observed in diabetic AN cannot be referred to an association with cardiovascular risk factors.

Adult↗
PubMed2006

Long-term clinical effects of epalrestat, an aldose reductase inhibitor, on diabetic peripheral neuropathy: the 3-year, multicenter, comparative Aldose Reductase Inhibitor-Diabetes Complications Trial.

OBJECTIVE: We sought to evaluate the long-term efficacy and safety of epalrestat, an aldose reductase inhibitor, on diabetic peripheral neuropathy. RESEARCH DESIGN AND METHODS: Subjects with diabetic neuropathy, median motor nerve conduction velocity (MNCV) >or=40 m/s, and HbA(1c) <or=9% were enrolled in this open-label, multicenter study and randomized to 150 mg/day epalrestat or a control group. After excluding the withdrawals, 289 (epalrestat group) and 305 (control group) patients were included in the analyses. The primary end point was change from baseline in median MNCV at 3 years. Secondary end points included assessment of other somatic nerve function parameters (minimum F-wave latency [MFWL] of the median motor nerve and vibration perception threshold [VPT]), cardiovascular autonomic nerve function, and subjective symptoms. RESULTS: Over the 3-year period, epalrestat prevented the deterioration of median MNCV, MFWL, and VPT seen in the control group. The between-group difference in change from baseline in median MNCV was 1.6 m/s (P < 0.001). Although a benefit with epalrestat was observed in cardiovascular autonomic nerve function variables, this did not reach statistical significance compared with the control group. Numbness of limbs, sensory abnormality, and cramping improved significantly with epalrestat versus the control group. The effects of epalrestat on median MNCV were most evident in subjects with better glycemic control and with no or mild microangiopathies. CONCLUSIONS: Long-term treatment with epalrestat is well tolerated and can effectively delay the progression of diabetic neuropathy and ameliorate the associated symptoms of the disease, particularly in subjects with good glycemic control and limited microangiopathy.

Adult↗