bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Effect of Short Periods of Caloric Restriction on Weight Loss and Glycemic Control in Type 2 Diabetes
Authors: Williams Katherine V , Mullen Monica L , Kelley David E , Wing Rena R 
Published: March 2007

OBJECTIVE
To determine whether an intermittent very-low-calorie diet (VLCD) improves weight loss and glycemic control more than moderate caloric restriction alone.

RESEARCH DESIGN AND METHODS
Individuals with type 2 diabetes (n = 54) who were ≥ 20% over ideal body weight participated in a 20-week behavioral weight control program. Subjects were randomized to either a standard behavioral therapy (SBT) group or to one of two VLCD groups. SBT subjects received a 1,500−1,800 kcal/day diet throughout. Both VLCD groups followed a VLCD for 5 consecutive days during week 2, followed by either intermittent VLCD therapy for 1 day/week for 15 weeks (1-day) or for 5 consecutive days every 5 weeks (5-day), with a 1,500−1,800 kcal/day diet at other times.

RESULTS
Both VLCD groups lost more weight than the SBT group over the 20 weeks (P = 0.04). Although the groups did not differ in fasting plasma glucose (FPG) changes at 20 weeks, more subjects in the 5-day group attained a normal HbA1c when compared with the SBT group (P = 0.04). This benefit was independent of the effects of weight loss. The best predictor of overall change in FPG and HbA1c was the FPG response during the first 3 weeks of the program.

CONCLUSIONS
Periodic VLCDs improved weight loss in diabetic subjects. A regimen with intermittent 5-day VLCD therapy seemed particularly promising, because more subjects in this group attained a normal HbA1c. Moreover, the glucose response to a 3-week period of diet therapy predicted glycemic response at 20 weeks, and it was a better predictor of the 20-week response than initial or overall weight loss.
The STOP-NIDDM Trial: An international study on the efficacy of an α-glucosidase inhibitor to prevent type 2 diabetes in a population with impaired glucose tolerance: rationale, design, and preliminary screening data
Authors: Chiasson Jean-Louis , Gomis Roman , Hanefeld Markolf , Josse Robert G , Karasik Avraham , Laakso Markku ,   The Stop-Niddm Trial Research Group
Published: March 2007

OBJECTIVE
To describe the rationale and design, and to discuss the preliminary screening data, of the Study to Prevent NIDDM (STOP-NIDDM Trial), an international study on the efficacy of the α-glucosidase inhibitor acarbose in preventing or delaying the development of type 2 diabetes in a population with impaired glucose tolerance (IGT).

RESEARCH DESIGN AND METHODS
A total of 1,418 subjects diagnosed with IGT according to the World Health Organization's criteria and having a fasting plasma glucose concentration ≥5.6 mmol/l were randomized in a double-blind fashion to receive either acarbose (100 mg t.i.d.) or placebo for a predictive median follow-up period of 3.9 years. The primary outcome is the development of type 2 diabetes diagnosed using a 75-g oral glucose tolerance test according to the new criteria. The secondary outcomes are changes in blood pressure, lipid profile, insulin sensitivity, cardiovascular events, and morphometric profile.

RESULTS
Screening was performed in a high-risk population. As of 1 March 1997, 4,424 subjects had been screened, and data were available for 3,919 (88.5%) subjects. Of these subjects, 1,200 (30.6%) had glucose intolerance. Of the subjects with glucose intolerance, 521 (13.3%) had previously undetected type 2 diabetes, and 679 (17.3%) had IGT. Of the IGT population, 412 (60.7%) subjects were eligible for the study. This population had the following characteristics: the mean age was 54.8 years, 52% of the subjects were female, 53% had more than one risk factor for type 2 diabetes, &gt;90% had a family history of diabetes, 78.2% had a BMI ≥27 kg/m2, 47.5% had high blood pressure, 51.2% had dyslipidemia, and 22.8% of the women had a history of gestational diabetes.

CONCLUSIONS
Screening of a high-risk population yields one eligible subject per every 10 volunteers screened. This study should definitely answer the question of whether acarbose can prevent or delay the progression of IGT to type 2 diabetes mellitus.
Efficacy and Safety of Acarbose in Metformin-Treated Patients With Type 2 Diabetes
Authors: Rosenstock Julio , Brown Ann , Fischer Jerome , Jain Adesh , Littlejohn Thomas , Nadeau Dan , Sussman Allen , Taylor Terry , Krol Alice , Magner James 
Published: March 2007

OBJECTIVE
To demonstrate the efficacy, tolerability, and safety of acarbosecompared with placebo in patients with type 2 diabetes inadequatelycontrolled with diet and metformin (2,000 or 2,500 mg/day in divideddoses).

RESEARCH DESIGN AND METHODS
This study had a multicenter randomized double-blind placebo-controlled parallel-group comparison design. The trial lasted 31 weeks and consisted of a 1-week screening period, a 6-week placebo pretreatment period, and a 24-week period of acarbose or placebo, with a forced titration from 25–50 mg t.i.d. and a titration of 50–100 mg tid that was based on glucose control. The primary efficacy variable wasthe mean change from baseline in HbAlc. Secondary efficacy variables included mean changes from baseline in fasting and postprandial plasma glucose, serum insulin, and triglyceride levels.

RESULTS
The addition of acarbose to patients on background metformin and diet therapy showed a statistically significant reduction in mean HbAlc of 0.65%. There were statistically significant reductions in fasting and postprandial plasma glucose and serum insulin levels compared with placebo. Gastrointestinal side effects were more frequently reported in the acarbose-treated patients. No significant differences in liver transaminase elevations were observed between patients treated with acarbose and those treated with placebo.

CONCLUSIONS
The results of this study demonstrate that the addition of acarbose to patients with type 2 diabetes who are inadequately controlled with metformin and diet is safe and generally well tolerated and that it significantly lowers HbAlc and fasting and postprandial glucoseand insulin levels.
Biological Variation of Glycated Hemoglobin: Implications for diabetes screening and monitoring
Authors: Kilpatrick Eric S , Maylor Paul W , Keevil Brian G 
Published: March 2007

OBJECTIVE
To assess the inherent potential of glycated hemoglobin as a screening test for type 2 diabetes by determining the biological variation in nondiabetic subjects.

RESEARCH DESIGN AND METHODS
HbA1c values were measured by high-performance liquid chromatography (HPLC) in 12 nondiabetic subjects (7 men and 5 women; median age, 40 years [range, 21–55 years]) on 10 fortnightly occasions. The nondiabetic index of individuality (IOI) for HbA1c (i.e., the square root of the ratio of intra- to interindividual variance) was determined. Any test with an IOI of 1.4 has the most potential in disease screening, while one of 0.6 will be of little value.

RESULTS
The analytical variance contributed to 9% of the total test variance, intraindividual variance, 6%; and interindividual variance, 85%. The IOI was, therefore, only 0.27. Thus, nondiabetic HbA1c values vary markedly between subjects, while values in the same individual change little with time. As such, to lie outside the assay reference range, the HbA1c values of some nondiabetic subjects must exceed 12 SD from their usual mean value, while in others a change of only 2 SD would be sufficient.

CONCLUSIONS
This fundamental characteristic of HbA1c means that even if analytical methods improve, glycated hemoglobin measurements will always be of limited value when screening for type 2 diabetes. If similar interindividual differences also exist in diabetic subjects, then patients with the same glycemic control may vary by at least 1–2%, which has implications in setting glycated hemoglobin targets.
Angiotensinogen T235 and ACE Insertion/Deletion Polymorphisms Associated With Albuminuria in Chinese Type 2 Diabetic Patients
Authors: Young Robert P , Chan Juliana C N , Critchley Julian A J H , Poon Emily , Nicholls Gary , Cockram Clive S 
Published: March 2007

OBJECTIVE
Genetic polymorphisms of the renin-angiotensin system (RAS) have been implicated in the pathogenesis of diabetic proteinuria. Ethnic differences in the frequencies of these genotypes have also been reported. To date, most of these studies have been performed in white and Japanese populations. In this study, we examined the associations between albuminuria and RAS genetic polymorphisms in Chinese patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS
In a case-control study, the ACE insertion/deletion (I/D) gene, the angiotensinogen (AGT) gene (M235T), and the angiotensin II (AII) type 1 receptor gene (AT1 A1166C) were examined in 110 Chinese type 2 diabetic patients. Increased urinary albumin excretion (UAE) was defined as ≥ 30 mg/day on at least two occasions during a 6-week study period.

RESULTS
Compared with whites, there were high frequencies of the AGT TT genotype in Chinese control subjects (120/183 = 70%) and type 2 diabetic patients (74/110 = 67%). The frequencies of the MM genotype were 5 and 3%, respectively, and those of the ACE DD genotype were 13 and 10%, respectively. Although 9% of subjects carried the C allele, the AT1 CC genotype was not found in either group. Chinese type 2 diabetic patients with increased albuminuria (n = 56) had higher systolic blood pressure (160 ± 26 mmHg vs 145 ± 27 mmHg, P &lt; 0.001) than the normoalbuminuric patients (n = 54). Both the AGT TT genotype (78.6% [44/56] vs. 55.6% [30/54], odds ratio [OR]: 3.0 [1.3–6.8]) and the T allele (88% [99/112] vs. 77% [83/108], OR: 2.5 [1.3–5.4]) were associated with an increased risk of albuminuria. Patients with the AGT TT genotype (n = 74) had higher 24-h UAE than those with the MT or MM genotypes (n = 36) (median: 37.8 mg/day vs. 17.8 mg/day, P &lt; 0.01). This association remained significant in patients with normotension (56 mg/day [n = 19] for patients with the TT genotype vs. 22 mg/day [n = 14] for those with the MT/MM genotype, P = 0.03). The D allele carriers (DD or DI, n = 61) had higher serum ACE activities (75.5 ± 29 U/l vs. 60.5 ± 36.3 U/l, P &lt; 0.01) than the noncarriers (II genotype). The median 24-h UAE also tended to be higher in the D allele carriers (38.9 mg/day vs. 21.4 mg/day, P = 0.07). The lowest UAE was observed in patients with the MM/MT/II genotype (16.3 mg/day [n = 18]) and the highest, in patients with the TT/DD/DI genotype (52.3 mg/day [n = 43]). No association was found between the TT genotype or D allele and hypertension.

CONCLUSIONS
The high frequencies of the TT genotype and T allele in Chinese populations may contribute to the high prevalence of albuminuria in patients with type 2 diabetes. The possibility of synergism between the AGT TT genotype and the ACE D allele should also be explored.
Glomerular Charge and Size Selectivity Assessed by Changes in Salt Intake in Type 2 Diabetic Patients
Authors: Yoshioka Katsunobu , Imanishi Masahito , Konishi Yoshio , Sato Toshihiko , Tanaka Shiro , Kimura Genjiro , Fujii Satoru 
Published: March 2007

OBJECTIVE
To evaluate glomerular charge selectivity in patients with type 2 diabetes, we studied changes in fractional clearance of proteins with different sizes and charges when patients were placed on two diets with different salt contents.

RESEARCH DESIGN AND METHODS
Nineteen patients with type 2 diabetes and normoalbuminuria (&lt;20 μg/min, n = 8), microalbuminuria (20–100 μg/min, n = 7), or advanced albuminuria (&gt;100 ug/min, n = 4) were placed on a low-salt diet (85 mEq of sodium daily) or a high-salt diet (255 mEq of sodium daily) for 1 week, and then on the other diet, in random order. Fractional clearances of albumin and immunoglobulin G (IgG) were calculated on the last 3 days of each diet.

RESULTS
In patients with normoalbuminuria, the high-salt diet increased the fractional clearance of IgG, which is electrically neutral, but the fractional clearance of albumin, which is anionic, was unaltered, suggesting that the pore charge of the glomerular barrier was unaffected. However, in patients with microalbuminuria, the high-salt diet increased the fractional clearances of IgG and albumin equally, indicating some neutralization of the pore charge. Fractional clearance of IgG in these first two groups was similar when salt intake was low, so pore size was the same in these groups. In patients with advanced albuminuria, fractional clearance of IgG was higher than in the other groups, indicating that size selectivity had worsened.

CONCLUSIONS
In type 2 diabetic patients, charge selectivity is lost before size selectivity as diabetic nephropathy progresses.
Serum Leptin Levels in Smokers With Type 2 Diabetes
Authors: Yoshinari Mototaka , Wakisaka Masanori , Fujishima Masatoshi 
Published: March 2007

OBJECTIVE
To elucidate the molecular mechanism of smoking cessation and its relationship to body weight gain, the effects of smoking on the serum levels of leptin were studied in Japanese patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS
The serum levels of leptin after an overnight fast in 37 adult male Japanese patients with type 2 diabetes (17 smokers and 20 nonsmokers) were assayed using radioimmunoassay In addition, the serum leptin levels in four nondiabetic smokers were measured before and 2 weeks after quitting smoking.

RESULTS
Smokers and nonsmokers did not differ in age, BM1, or levels of blood glucose and fasting insulin but did differ in HDL cholesterol levels (1.07 ± 0.18 vs. 1.32 ± 0.24 mmol/1 for smokers and nonsmokers, respectively, P = 0.002). The mean serum leptin level of smokers did not differ from that of nonsmokers (3.8 ± 1.9 vs. 3.8 ± 1.6 ng/ml). The leptin level correlated with the fasting insulin level and BMI (r = 0.55 and 0.56, P &lt; 0.001 and 0.001, respectively). The leptin levels in four heavy smokers showed no change after the subjects quit smoking (3.3 ± 1.0 vs. 3.8 ± 1.8 ng/ml, before and after quitting, respectively).

CONCLUSIONS
Because smoking did not affect the leptin levels, the effects of quitting smoking on the fuel metabolism appear to be due to some other factors.
Prevalence of Diabetes, Impaired Fasting Glucose, and Impaired Glucose Tolerance in U.S. Adults: The Third National Health and Nutrition Examination Survey, 1988–1994
Authors: Harris Maureen I , Flegal Katherine M , Cowie Catherine C , Eberhardt Mark S , Goldstein David E , Little Randie R , Wiedmeyer Hsiao-Mei , Byrd-Holt Danita D 
Published: March 2007

OBJECTIVE
To evaluate the prevalence and time trends for diagnosed and undiagnosed diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults by age, sex, and race or ethnic group, based on data from the Third National Health and Nutrition Examination Survey, 1988–1994 (NHANES 111) and prior Health and Nutrition Examination Surveys (HANESs).

RESEARCH DESIGN AND METHODS
NHANES III contained a probability sample of 18,825 U.S. adults ≥20 years of age who were interviewed to ascertain a medical history of diagnosed diabetes, a subsample of 6,587 adults for whom fasting plasma glucose values were obtained, and a subsample of 2,844 adults between 40 and 74 years of age who received an oral glucose tolerance test. The Second National Health and Nutrition Examination Survey, 1976–1980, and Hispanic HANES used similar procedures to ascertain diabetes. Prevalence was calculated using the 1997 American Diabetes Association fasting plasma glucose criteria and the 1980–1985 World Health Organization (WHO) oral glucose tolerance test criteria.

RESULTS
Prevalence of diagnosed diabetes in 1988–1994 was estimated to be 5.1% for U.S. adults ≥20 years of age (10.2 million people when extrapolated to the 1997 U.S. population). Using American Diabetes Association criteria, the prevalence of undiagnosed diabetes (fasting plasma glucose ≥126 mg/dl) was 2.7% (5.4 million), and the prevalence of impaired fasting glucose (110 to &lt;126 mg/dl) was 6.9% (13.4 million). There were similar rates of diabetes for men and women, but the rates for non-Hispanic blacks and Mexican-Americans were 1.6 and 1.9 times the rate for non-Hispanic whites. Based on American Diabetes Association criteria, prevalence of diabetes (diagnosed plus undiagnosed) in the total population of people who were 40–74 years of age increased from 8.9% in the period 1976–1980 to 12.3% by 1988–1994. A similar increase was found when WHO criteria were applied (11.4 and 14.3%).

CONCLUSIONS
The high rates of abnormal fasting and postchallenge glucose found in NHANES III, together with the increasing frequency of obesity and sedentary lifestyles in the population, make it likely that diabetes will continue to be a major health problem in the U.S
Incidence and Determinants of Microalbuminuria in Koreans With Type 2 Diabetes
Authors: Park Joong-Yeol , Kim Hong-Kyu , Chung Yun E , Kim Sang W , Hong Sung K , Lee Ki-Up 
Published: March 2007

OBJECTIVE
The incidence of diabetic nephropathy in type 2 diabetes differs widely by race. Although clinical proteinuria is reportedly more common in East Asian type 2 diabetic patients than in their Caucasian counterparts, data on the incidence of microalbuminuria are not available. This study was undertaken to investigate the incidence and the determinants of microalbuminuria in Korean type 2 diabetic patients.

RESEARCH DESIGN AND METHODS
A cohort of 188 Korean type 2 diabetic patients with initial normoalbuminuria were followed prospectively for 5.5 ± 0.9 years in an outpatient clinic of a university hospital. The incidence of elevated urinary albumin excretion (UAE) (&gt;20 μg/min) and its relationship with baseline characteristics and follow-up data were determined.

RESULTS
Of the 146 patients who finished the study, 37 showed persistently elevated UAE during follow-up, giving an incidence of 52/1,000 person-years. Age, duration of diabetes, and baseline UAE were significantly higher in the progressors than in the nonprogressors. More patients in the progressor group had retinopathy at baseline and at the end of follow-up. The mean values of fasting plasma glucose, HbA1, and systolic and diastolic blood pressure during the follow-up period were significantly higher in the progressors than in the nonprogressors. Cox proportional hazards analysis revealed that presence of retinopathy, duration of diabetes, mean fasting plasma glucose, and mean systolic blood pressure during follow-up are independent variables that have a statistically significant influence on the development of microalbuminuria.

CONCLUSIONS
The incidence of microalbuminuria in Korean type 2 diabetic patients is lower than that reported in Pima Indians with type 2 diabetes but is as high as that in Caucasians with type 1 diabetes. Presence of diabetic retinopathy, poor glycemic control, and high blood pressure are risk factors for development of microalbuminuria in Koreans with type 2 diabetes.
The Effect of Glycemic Control in the Pre-Conception Period and Early Pregnancy on Birth Weight in Women With IDDM
Authors: Gold Ann E , Reilly Rena , Little Jill , Walker James D 
Published: March 2007

OBJECTIVE
To examine data from pregnancies in women with IDDM to assess the relative effects of mean glycosylated hemoglobin levels before conception, at booking, and during the 3 trimesters of pregnancy on birth weight. Good glycemic control during pregnancy in women with IDDM is important to minimize the risk of fetal malformation and macrosomia. Recent studies have suggested that glycemic control in the 1st trimester is more important than glycemic control during the 2nd or 3rd trimesters.

RESEARCH DESIGN AND METHODS
The case records of 65 deliveries to women with IDDM were reviewed. Fifty-seven deliveries were included in the present study. Of the deliveries reviewed, 32 women were in their first pregnancy and 25 women were multiparous. Only viable pregnancies were included because the major outcome variable of interest was birth weight. Glycosylated hemoglobin was recorded for each time period.

RESULTS
The median standardized birth weight was 1.1 SD higher than the nondiabetic mean. When pregnancies, in which the birth weight was greater than 1 SD above the nondiabetic mean, were compared with pregnancies, in which birth weight was less than 1 SD above the mean, significant differences were observed between the groups in HbA1 at 6–12 months pre-conception (10.0 ± 2.3 vs. 8.6 ± 1.4%, P = 0.02), at 0–6 months pre-conception (10.2 ± 2.4 vs. 8.7 ± 2.0%, P = 0.03), at booking (9.5 ± 2.2 vs. 8.4 ± 1.6%, P = 0.04), and at 0–12 weeks' gestation (9.5 ± 2.2 vs. 8.0 ± 1.3%, P = 0.04), but HbA1 later in pregnancy did not differ significantly between the groups. Correlational analysis of all 57 pregnancies revealed significant correlations between birth weight and HbA1 at 0–6 months pre-conception (r = 0.44, P = 0.002), at booking (r = 0.43, P = 0.001), at 0–12 weeks' gestation (r = 0.48, P = 0.001), at 12–24 weeks' gestation (r = 0.45, P = 0.001), and at 24 weeks to term (r = 0.34, P = 0.009). However, with stepwise regression analysis, only HbA1 at 0–12 weeks' gestation entered into the equation with a multiple r value of 0.48.

CONCLUSIONS
Glycemic control in the immediate pre-conception period and early 1st trimester appears to have a greater influence on birth weight than does glycemic control during the later weeks of pregnancy.
The Prevalence of Diabetes in a Swedish Population of 280,411 Inhabitants: A report from the Skaraborg Diabetes Registry
Authors: Berger Bo , Stenström Gunnar , Chang Yue-Fang , Sundkvist Göran 
Published: March 2007

OBJECTIVE
To estimate the prevalence of known diabetes in a Swedish county (Skaraborg) and to evaluate capture-recapture methods for validation of the diabetes prevalence.

RESEARCH DESIGN AND METHODS
Four sources were used to find known diabetic patients: 1) the Skaraborg Diabetes Registry (SDR), a case-finding inventory 2) an administrative hospital registry 3) a registry for the retinopathy screening program, and 4) a pharmacy prescription inventory. The capture-recapture method was applied to various combinations of sources to determine the prevalence of diabetes.

RESULTS
The completeness of the SDR was 88.4 ± 1.3%, indicating a diabetes prevalence of 3.20 ± 0.08%. When the SDR was not used as one of the sources, the estimated prevalence varied between 2.2 and 4.5%.

CONCLUSIONS
A case-finding registry is important in reliably estimating the prevalence of diabetes.