bluuebunny/crossref_metadata_2025_split huggingface dataset:
An Asian Multicenter Clinical Trial to Assess the Efficacy and Tolerability of Acarbose Compared With Placebo in Type 2 Diabetic Patients Previously Treated With Diet
Authors: Chan Juliana CN , Chan Kin-Wei A , HO Larry LT , Fuh Martin MC , Horn Lee Chung , Sheaves Richard , Panelo Araceli A , Kim Duk-Kyu , Embong Mustaffa ,   For the Asian Acarbose Study Group
Published: March 2007

OBJECTIVE
To assess the efficacy, safety, and tolerability of acarbose versus placebo during a 24-week treatment period in Asian type 2 diabetic patients with dietary failure.

RESEARCH DESIGN AND METHODS
After a 6-week screening period, 126 multiethnic Asian type 2 diabetic patients (64 men, 62 women; mean age ± SD, 53.4 ± 10 years) were randomized to receive acarbose (n = 63) or placebo (n = 63). The dosage was increased from 50 mg t.i.d. at week 0 to 100 mg t.i.d. at week 4. Patients were then followed up at weeks 10, 16, and 24. At each visit, body weight, blood pressure, and metabolic indexes were measured. At weeks 0 and 24, fasting plasma glucose and insulin were measured before and 1 h after the administration of an individually tailored breakfast.

RESULTS
Using the intention-to-treat analysis, there were greater reductions in (mean [95% CI]) HbA1c (−0.70 [−1.00 to −0.39] vs. −0.27% [−0.54 to 0]; P = 0.04), fasting plasma glucose (−0.37 [−0.75 to 0.02] vs. 0.41 mmol/1 [−0.08 to 0.90]; P = 0.017) and 1-h plasma glucose (−0.77 [−1.44 to −0.10] vs. 0.65 mmol/1 [−0.07 to 1.36]; P = 0.05) in the acarbose group compared with the placebo group. With acarbose treatment, 78% of patients achieved an HbA1c &lt;8% compared with 56% in the placebo group (P = 0.003). There was a greater reduction in body weight (−1.31 [−2.46 to −0.15] vs. 0.16 kg [−3.36 to 0.10]; P = 0.02) and higher incidence of flatulence (56 vs. 37%; P = 0.032) in the acarbose than in the placebo group. Using baseline HbA1c and race as covariates, there were no significant interethnic differences in treatment responses (P = 0.232 for treatment-race interaction; P &lt; 0.001 for treatment effect). The dropout rates were similar between the two groups (acarbose, 11 of 63; placebo, 6 of 63). There were no significant laboratory adverse events in either group.

CONCLUSIONS
In this multicenter study involving six ethnic groups, acarbose 100 mg t.i.d. was an effective, safe, and generally well-tolerated therapy in Asian type 2 diabetic patients with dietary failure. In some patients with troublesome gastrointestinal symptoms, a lower dosage may be necessary.
Rigiscan Evaluation of Specific Nervous Impairment in Patients With Diabetes and Erectile Disorders
Authors: Bax Giuseppe , Marin Narciso , Piarulli Francesco , Lamonica Mario , Bellio Fabiana , Fedele Domenico 
Published: March 2007

OBJECTIVE
A proposed new, minimally invasive, and painless method for studying impairment of the autonomic system of the penile region in type 2 diabetes patients.

RESEARCH DESIGN AND METHODS
Thirteen subjects were selected from 150 patients with type 2 diabetes and erectile dysfunction who were studied in accordance with the National Institutes of Health consensus. The 13 subjects (group A), aged 55 ± 8 years, had acceptable metabolic control (HbA1c, &lt;8%); no arterial or venous diseases or initial Peyronie's disease, as evaluated by penile Doppler ultrasonography and intracavernous prostaglandin E1 injection; and penile tumescence at the base (PTB) &lt;30 mm. Group B consisted of 13 control subjects with the same characteristics, including mean age (53.1 ± 9 years), metabolic control (HbA1c, 7.3 ± 0.7%), and duration of disease (8.3 ± 0.7 years), but PTB was =30 mm. Student's t test was used to evaluate differences in the results of autonomic cardiovascular tests, somatic tests (vibration perception threshold [VPT]), and diabetic neuropathy score (DNS) in both groups. The coefficient of variation of PTB was evaluated using the Rigiscan device (Dacomed, Minneapolis, MN), and Bayes' test was used to test sensitivity, specificity, and positive predictive values of the cardiovascular tests.

RESULTS
Patients with PTB &lt;30 mm had significant (P &lt; 0.05) impairment of parasympathetic tests (lying to standing, P &lt; 0.02; standing to lying, P &lt; 0.04; squat test, P &lt; 0.03) compared with subjects with higher PTB values. No difference in DNS and VPT at the base and tip of the penis was found between the two groups. The variability of the test is 10% in normal subjects and 15% in both groups of patients. PTB sensitivity was 54%, specificity 89%, and positive predictive value 79%.

CONCLUSIONS
In patients with diabetes and without vascular diseases, the PTB evaluated by Rigiscan is related to impairment of the autonomic nervous system. A PTB value &lt;30 mm may be considered a useful, noninvasive marker in studying parasympathetic damage of the penile region.
Potential Economic Benefits of Lower-Extremity Amputation Prevention Strategies in Diabetes
Authors: Ollendorf Daniel A , Kotsanos James G , Wishner William J , Friedman Mark , Cooper Tamara , Bittoni Marisa , Oster Gerry 
Published: March 2007

OBJECTIVE
To estimate the potential economic benefits of selected strategies from published literature—educational interventions, multidisciplinary clinics, and insurance coverage for therapeutic shoes—to reduce the incidence of lower-extremity amputation among individuals with diabetes.

RESEARCH DESIGN AND METHODS
We developed a model to estimate the expected incidence and associated costs of lower-extremity amputation in a hypothetical cohort of 10,000 people with diabetes. Prevention strategies were assumed to be targeted at individuals with a history of foot ulcer, and benefits were estimated over a period of 3 years.

RESULTS
The total potential economic benefits (discounted at 5%) of strategies to reduce amputation risk ranged from $2.0 to $3.0 million ($2,900 to $4,442 per person with a history of foot ulcer) over 3 years. Benefits were highest for educational interventions. Most benefits were found to accrue among individuals aged ≥ 70 years.

CONCLUSIONS
Strategies to reduce the risk of lower-extremity amputation may generate substantial economic benefits and should be a standard component of routine diabetes care. Benefits may best be achieved through a partnership of government, private payers, health care service providers and producers, and individuals with diabetes.
Effect of Glycemic Control on Glucose Counterregulation During Hypoglycemia in NIDDM
Authors: Levy Carol J , Kinsley Brendan T , Bajaj Mandeep , Simonson Donald C 
Published: March 2007

OBJECTIVE
We examined the effect of glycemic control of NIDDM on counterregulatory hormone responses to hypoglycemia and compared the effect with that seen in patients with IDDM.

RESEARCH DESIGN AND METHODS
Eleven subjects with NIDDM and eight age- and weight-matched control subjects and ten subjects with IDDM and ten age- and weight-matched control subjects were studied. All subjects underwent a stepped hypoglycemic-hyper-insulinemic clamp study during which plasma glucose levels were lowered in a stepwise manner from 5.0 to 2.2 mmol/l in steps of 0.6 mmol/l every 30 min. Counterregulatory hormones (epinephrine, norepinephrine, glucagon, ACTH, cortisol, and growth hormone [GH]) were measured, and a symptom survey was administered during the last 10 min of each 30-min interval.

RESULTS
The threshold for release of epinephrine, norepinephrine, ACTH, and cortisol occurred at higher plasma glucose levels in NIDDM than in IDDM patients (P &lt; 0.05–0.01). The glucose threshold for release of epinephrine and norepinephrine correlated with glycemic control as measured by glycosylated hemoglobin (P &lt; 0.05–0.01). However, for a given level of glycemic control, the threshold for release of epinephrine and norepinephrine occurred at a higher glucose level in NIDDM versus IDDM patients (P &lt; 0.05–0.01). At the nadir level of hypoglycemia, glucagon, ACTH, and cortisol levels were all higher in NIDDM compared with IDDM subjects, whereas GH levels were lower.

CONCLUSIONS
Glycemic control alters counterregulatory responses to hypoglycemia in NIDDM as has been previously reported in IDDM. However, at similar levels of glycemic control, NIDDM patients release counterregulatory hormones at a higher plasma glucose level than patients with IDDM. In addition, subjects with NIDDM maintain their glucagon response to hypoglycemia. These data suggest that patients with NIDDM may be at reduced risk of severe hypoglycemia when compared with a group of IDDM patients in similar glycemic control, thus providing a more favorable risk-benefit ratio for intensive diabetes therapy in NIDDM.
Dissociation of Microangiopathy and Macroangiopathy in Patients With Type 2 Diabetes
Authors: Yamamoto Maki , Egusa Genshi , Okubo Masamichi , Yamakido Michio 
Published: March 2007

OBJECTIVE
Although persistent hyperglycemia contributes greatly to the progression of diabetic micro- and macroangiopathy, microangiopathy progresses more rapidly than macroangiopathy in some type 2 diabetic patients, with the opposite being true in others. This study was conducted to identify factors responsible for such dissociation.

RESEARCH DESIGN AND METHODS
Patients with proliferative diabetic retinopathy and a carotid intima-media thickness (IMT) level ≤1.0 mm were classified as the microangiopathy group (MIG); those with an IMT level &gt;1.1 mm and without retinopathy or with background retinopathy were assigned to the macroangiopathy group (MAG). Only middle-aged patients, 50–69 years old, were included in this study. There were 54 patients in the MIG and 68 patients in the MAG.

RESULTS
Patients in the MIG were significantly younger at the onset of diabetes, and those in the MAG had a significantly higher mean ratio of apoprotein (apo) B to apoAI. The percentage of patients with a family history of diabetes was significantly higher in the MIG. Maternal inheritance was common among these patients. Those with obesity, a family history of diabetes, and younger onset of hypertension were more common in the MAG. In the multiple logistic regression analyses, maternal inheritance and early onset of diabetes were independent risk factors for the acceleration of microangiopathy. A personal history of obesity and a family history of hypertension were independently related to the development of macroangiopathy.

CONCLUSIONS
Our results suggest that patients with early onset and maternal inheritance of diabetes may have a high risk for the progression of diabetic microangiopathy, while patients with hyperlipidemia, a history of obesity, and a family history of hypertension seem prone to the development of atherosclerosis.
Meal-Generated Oxidative Stress in Type 2 Diabetic Patients
Authors: Ceriello Antonio , Bortolotti Nadia , Motz Enrico , Crescentini Adriana , Lizzio Sebastiano , Russo Assunta , Tonutti Laura , Taboga Claudio 
Published: March 2007

OBJECTIVE
Free radical production has been reported to be increased in diabetic patients and to be involved in the pathogenesis of diabetic complications. In this study, a standardized meal was administered to 10 type 2 diabetic patients and 10 healthy matched normal subjects to evaluate its effects on plasma oxidative stress generation.

RESEARCH DESIGN AND METHODS
In diabetic patients, at baseline and after the meal, plasma malondialdehyde (MDA), vitamin C, protein SH groups, uric acid, vitamin E, and total plasma radical-trapping parameter, which evaluates plasma antioxidant capacity due to known and unknown antioxidants present in the plasma as well as their mutual cooperation, were measured.

RESULTS
After the meal, plasma MDA and vitamin C increased, while protein SH groups, uric acid, vitamin E, and total plasma radical-trapping parameter decreased more significantly in the diabetic subjects than in control subjects.

CONCLUSIONS
This finding shows that in the absorptive phase, free radicals are produced in diabetic patients. Since plasma glucose, but not insulin, rose significantly more in diabetic subjects than in control subjects, hyperglycemia may play an important role in the generation of postprandial oxidative stress in diabetic patients.
Increased Left Ventricular Mass in Normotensive Type 1 Diabetic Patients With Diabetic Nephropathy
Authors: Sato Asako , Tarnow Lise , Parving Hans-Henrik 
Published: March 2007

OBJECTIVE
Diabetic nephropathy increases the risk of premature cardiovascular disease and sudden death, particularly in type 1 diabetic patients. One possible mechanism for this risk may be left ventricular hypertrophy. In our study, we aimed to evaluate left ventricular structure and function in normotensive type 1 diabetic patients with and without nephropathy.

RESEARCH DESIGN AND METHODS
M-mode and Doppler echocardiography was performed in 17 type 1 diabetic patients with nephropathy (albuminuria [median (range)], 345 (135–2,846) mg/24 h) and compared with 34 normotensive, normoalbuminuric (10 [3–30] mg/24 h) type 1 diabetic patients matched for arterial blood pressure (mean ± SD) ([134/77] ± [13/7] vs. [129/78] ± [12/7] mmHg), age (40 ± 11 vs. 42 ± 10 years), duration of diabetes (28 ± 7 vs. 28 ± 6 years), and BMI (24.2 ± 4.2 vs. 24.6 ± 2.4 kg/m2).

RESULTS
Left ventricular mass (LVM) index was significantly higher in patients with nephropathy compared with patients with normoalbuminuria (100.8 ± 10.3 vs. 88.2 ± 21.0 g/m2, respectively; P = 0.02). Greater ventricular septum width was demonstrated in the nephropathic group compared with the control group (9.4 ± 1.0 vs. 8.2 ± 1.3 mm, respectively; P = 0.002). No significant difference in posterior wall thickness was apparent. The nephropathic group tended to have reduced diastolic function (E/A ratio, 1.2 ± 0.3 vs. 1.4 ± 0.4; P = 0.09). Fractional shortening was normal and about the same in the two groups. The groups did not differ with respect to serum creatinine or hemoglobin, while metabolic control (assessed by HbA1c) and plasma renin and prorenin levels were elevated in the nephropathic group compared with the normoalbuminuric group.

CONCLUSIONS
A blood pressure-independent increase in LVM may contribute to the increased cardiac morbidity and mortality in normotensive type 1 diabetic patients with diabetic nephropathy. Glycemic abnormalities and activation of the renin-angiotensin system may lead to the ventricular enlargement.
Flexible Meal-Related Dosing With Repaglinide Facilitates Glycemic Control in Therapy-Naive Type 2 Diabetes
Authors: Moses Robert G. , Gomis Ramon , Frandsen Kirstine Brown , Schlienger Jean-Louis , Dedov Ivan 
Published: March 2007

OBJECTIVE— This double-blind randomized placebo-controlled parallel group study assessed the efficacy and safety (with particular regard to body weight and hypoglycemia) of repaglinide when used in a flexible mealtime dosing regimen in a situation close to everyday clinical practice.
RESEARCH DESIGN AND METHODS— A total of 408 patients with type 2 diabetes considered poorly controlled by diet, but without a history of previous antidiabetic medication, were randomized to receive 0.5 mg repaglinide at mealtimes (increased to 1 mg after 4 weeks depending on blood glucose response) or placebo for 16 weeks. Patients were free to choose a flexible meal pattern, adjusting the dosing schedule from two to four preprandial doses per day in accordance with a “one meal, one dose; no meal, no dose” principle. Additional snacks were not a requirement of the treatment schedule.
RESULTS— Treatment with repaglinide significantly improved glycemic control with respect to baseline and placebo, reducing HbAlc by 1.14% from baseline and fasting plasma glucose by 1.8 mmol/l. Improvement in glycemic control was independent of the meal pattern adopted by patients, including those most commonly taking two or four meals daily, with no correlation between meal pattern and risk of hypoglycemia. The improvement in glycemic control was also independent of degree of obesity and age ≤65 or &gt;65 years. There was no significant body weight increase in the repaglinide group.
CONCLUSIONS— Mealtime dosing with repaglinide is effective in improving overall glycemic control in type 2 diabetic patients for which control is suboptimal using diet alone. Patients are able to vary their meal pattern from a conventional regimen of three meals daily without compromising control or increasing the risk of adverse events.
Efficacy, Safety, and Pump Compatibility of Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes
Authors: Bode Bruce W. , Strange Poul 
Published: March 2007

OBJECTIVE— The purpose of this study was to compare the efficacy, safety, and pump compatibility of insulin aspart (a rapid-acting insulin analog) and buffered regular human insulin in patients with type 1 diabetes undergoing continuous subcutaneous insulin infusion (CSII)therapy.
RESEARCH DESIGN AND METHODS— This was a single-center randomized openlable study. Patients received CSII therapy with insulin aspart(n = 19) or buffered regular human insulin (n = 10) for 7 weeks. Bolus doses of insulin aspart were administered immediately before meals and buffered regular human insulin 30 min before meals.
RESULTS— Insulin aspart and buffered regular human insulin were both effective in controlling average daily blood glucose levels (8.2± 1.9 and 8.5 ± 2.1 mmol/l, respectively) (mean ± SD) and maintaining serum fructosamine (343 ± 25.7 and 336 ± 27.4μmol/l) and HbAlc (6.9 ± 0.6 and 7.1 ± 0.6 %)levels. Possible obstructions and set leakages were infrequently reported in both groups. Similar numbers of patients experienced hypoglycemia (blood glucose &lt;2.5 mmol/l): 14 (74%) insulin aspart patients versus 6 (60%)buffered regular human insulin patients. Patients receiving insulin aspart had fewer hypoglycemic events per patient (2.9) than those patients receiving buffered regular human insulin (6.2). There were no differences between the two insulins in the occurrence of hyperglycemic events (blood glucose &gt;19 mmol/l) or in the number and type of adverse events.
CONCLUSIONS— Insulin aspart and buffered regular human insulin were effective and well tolerated and provided similar pump compatibility when used in CSII therapy.
Insulin Resistance and Insulin Secretory Dysfunction Are Independent Predictors of Worsening of Glucose Tolerance During Each Stage of Type 2 Diabetes Development
Authors: Weyer Christian , Tataranni P. Antonio , Bogardus Clifton , Pratley Richard E. 
Published: March 2007

OBJECTIVE— Although prospective studies indicate that insulin resistance and insulin secretory dysfunction predict type 2 diabetes, they provide limited information on the relative contributions of both abnormalities to worsening glucose tolerance at different developmental stages of the disease. We therefore assessed the predictive effect of insulin resistance and insulin secretory dysfunction separately for the progression from normal glucose tolerance (NGT) to impaired glucose tolerance (IGT) and from IGT to diabetes.
RESEARCH DESIGN AND METHODS— Insulin-stimulated glucose disposal (M) (hyperinsulinemic clamp), acute insulin secretory response (AIR) (25-g intravenous glucose tolerance test), and body composition(hydrodensitometry or dual-energy X-ray absorptiometry) were measured in 254 Pima Indians with NGT and in 145 Pima Indians with IGT, who were then followed for 0.5-13 years.
RESULTS— After follow-ups of 4.4 ± 3.1 and 5.5 ±3.4 years, 79 (31%) of the subjects with initial NGT had developed IGT, and 64(44%) of the subjects with initial IGT had developed diabetes. In proportional-hazards analyses with adjustment for age, sex, and percent body fat, low M and low AIR were independent predictors of both the progression from NGT to IGT (relative hazards [95% CI] for 10th vs. 90th percentile: M 2.4 [1.2-4.7], P &lt; 0.02; AIR 2.1 [1.1-4.1], P &lt; 0.04) and from IGT to diabetes (M 2.5 [1.3-5.0], P &lt; 0.01; AIR 1.8 [0.99-3.3], P = 0.055).
CONCLUSIONS— During each stage of the development of type 2 diabetes, insulin resistance and insulin secretory dysfunction are independent predictors of worsening glucose tolerance and are, therefore, both targets for the primary prevention of the disease.
Postchallenge Hyperglycemia in a National Sample of U.S. Adults With Type 2 Diabetes
Authors: Erlinger Thomas P. , Brancati Frederick L. 
Published: March 2007

OBJECTIVE—Postchallenge hyperglycemia (PCH) is known to contribute to suboptimal glycemic control in adults with non–insulin-requiring type 2 diabetes. The objective of this study was to estimate the prevalence of PCH among individuals with diabetes.
RESEARCH DESIGN AND METHODS—We conducted a cross-sectional analysis of data from the Third National Health and Nutrition Examination Survey (1988–1994) in adults aged 40–74 years with diabetes who were not using insulin (i.e., they used oral hypoglycemics or received no pharmacological therapy). Each respondent underwent a standard 75-g oral glucose tolerance test. PCH was defined as a 2-h glucose level ≥200 mg/dl.
RESULTS—Overall, PCH was present in 74% of those with diagnosed diabetes. Although it was present in virtually all (99%) of the diabetic adults under suboptimal glycemic control (HbA1c ≥7.0%), PCH was also common (39%) among those under optimal control (HbA1c &lt;7.0%). Likewise, among sulfonylurea users, PCH was present in 99% of those under suboptimal control and in 63% of those under good control. Similar patterns were observed in those with undiagnosed diabetes. Isolated PCH (2-h glucose ≥200 mg/dl and fasting glucose &lt;126 mg/dl) was present in 9.8% of the adults with diagnosed diabetes.
CONCLUSIONS—These data suggest that PCH is common among diabetic adults in the U.S., even in the setting of “optimal” glycemic control and sulfonylurea use. Interventions designed to lower postprandial glucose excursions may help improve overall glycemic control in the general population of U.S. adults with diabetes.
Mediators of Lifestyle Behavior Change in Native Hawaiians
Authors: Mau Marjorie K. , Glanz Karen , Severino Richard , Grove John S. , Johnson Bruce , Curb J. David 
Published: March 2007

OBJECTIVE—To examine the association of stage of change with diet and exercise behaviors in response to a lifestyle intervention for Native Hawaiians (NHs).
RESEARCH DESIGN AND METHODS—A family (‘ohana) support lifestyle intervention was compared with a standard intervention in NHs with or at risk for diabetes in two rural communities in Hawaii (n = 147). Stage of change, as a hypothesized mediator of behavior change, and dietary and exercise behaviors were measured at baseline and at 1 year postintervention.
RESULTS—Stage of change was significantly associated with positive dietary and exercise behaviors. NHs receiving the ‘ohana support (OS) intervention were more likely to advance from pre-action to action/maintenance for fat intake and physical activity than the group who received the standard intervention. Participants in the OS group who advanced from pre-action to action/maintenance showed more improvement in fat intake and physical activity than those in the standard group.
CONCLUSIONS—These initial findings suggest that stage of change is an important factor in mediating lifestyle behavior changes in persons with or at risk for diabetes and merits further study among minority populations at high risk for diabetes.