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Query: UMLS:C0011860 (type 2 diabetes)
 57,723 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Advanced glycosylation endproduct (AGE) formation has been implicated in the development and progression of nephropathy in type 2 diabetes mellitus. In diabetic animals, aminoguanidine inhibits AGE-mediated cross-linking of proteins in vascular and renal tissue and slows the progression of renal disease. ACTION II is a randomized, double-blind, placebo-controlled trial comparing two dose levels of aminoguanidine with placebo on the progression of nephropathy in 599 type 2 diabetic patients with renal disease from 84 centers in the United States and Canada. The primary endpoint is time to doubling of serum creatinine concentration. Secondary endpoints include the effect of aminoguanidine on time to all-cause mortality, end-stage renal disease (ESRD), cardiovascular morbidity and mortality, rate of change in indices of renal function (iothalamate, Cockcroft and Gault [C&G] calculated creatinine and measured creatinine clearances), proteinuria, retinopathy, circulating and urinary AGE levels, and estimation of the relationship between plasma aminoguanidine concentrations and primary and secondary efficacy endpoints and adverse events. Progression of macrovascular disease was monitored and fundus photography performed. Type 2 diabetic patients aged 30 to 70 years were eligible for the trial if their blood pressure was < or =180 mm Hg systolic and < or =120 mm Hg diastolic, serum creatinine concentration > or =1.0 mg/dL (in women) or > or =1.2 mg/dL (in men), C&G clearance > or =40 mL/min, and proteinuria > or =500 mg/d with diabetic retinopathy or diabetic nephropathy on renal biopsy. Recruitment began in July 1995 and terminated in December 1996. The trial randomized a total of 599 subjects. At baseline, the mean (standard deviation [SD]) age was 58 (7.7) years, diabetes duration 16.5 (7.5) years, body mass index 32 kg/m2 (10-90% range 2642), arterial blood pressure 105 (12) mm Hg, C-peptide concentration 2.55 (1.71) ng/mL, serum glucose concentration 201 (89) mg/dL, hemoglobin A1c 8.7% (1.6), serum creatinine concentration 1.6 (0.5) mg/dL, iothalamate clearance 52 (25) mL/min/1.73 m2, proteinuria 4.1 (4.2) g/d, triglycerides 259 (214) mg/dL, and LDL cholesterol 144 (40) mg/dL. Patients are 72% male, 68% white, 16% black, and 16% Asian American and Native American. At baseline, 76% were receiving concomitant angiotensin-converting enzyme (ACE) inhibitors and 43% lipid-lowering agents. Follow-up in ACTION II was scheduled to continue through December 1998, so that follow-up was to be 2 years after the date of randomization of the final enrolled patient. The trial in fact ended in March 1998. This trial will contribute to our understanding of the natural history of type 2 diabetes mellitus-associated nephropathy and determine whether aminoguanidine will slow the progression of established diabetic renal disease.
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PMID:Design and baseline characteristics for the aminoguanidine Clinical Trial in Overt Type 2 Diabetic Nephropathy (ACTION II). 1050 9

The objective of the Diabetes Prevention Program (DPP) is to prevent or delay the development of type 2 diabetes in those high-risk individuals who have tested positive for impaired glucose tolerance on an oral glucose tolerance test. The DPP is a multicenter randomized clinical trial in the U.S. with three intervention arms--lifestyle, metformin, and placebo--with 1,000 participants in each arm who will be recruited over a 3-year recruitment period and will be followed for 3 years after the study-wide closing date for recruitment, resulting in a 3- to 6-year participant follow-up interval. The primary outcome is the development of diabetes according to the revised American Diabetes Association criteria, confirmed with a repeat test. Recruitment ended in the spring of 1999. As of 14 October 1998, the DPP had screened 133,683 individuals, of whom 26,518 had an oral glucose tolerance test, resulting in 3,048 randomized participants (585 of who were former troglitazone arm participants). Of the randomized participants, approximately 45% belong to an ethnic minority group, 67% are women, and 10% are > or = 65 years old. In conclusion, recruitment of subjects for the DPP has been highly successful, particularly with respect to recruitment of minority participants.
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PMID:Background and recruitment data for the U.S. Diabetes Prevention Program. 1086 Jan 85

This paper presents the baseline epidemiological data from 5548 patients with type 2 diabetes enrolled in a French observational study that aims to examine the safety, tolerability and use of acarbose as prescribed by general practitioners (GPs). Patients were recruited and monitored by a representative sample of GPs. Recruitment did not depend on a patient's suitability for acarbose treatment. The data revealed that the mean age of the patient population was 63 years, and that more than 50% of patients were over 65 years old. The population was markedly overweight [mean body mass index(BMI): males, 28.4 kg/m(2); females, 29.1 kg/m(2)] and the mean duration of diabetes was 10 (+/-7.3) years. Over 37% of patients had at least one diabetic complication, and the frequency of complications increased with both age and the duration of diabetes. The most frequently reported complications were cardiac (17.8%), vascular (14.5%) and ocular (12%). At recruitment, almost 90% of patients were being treated with oral antidiabetic agents (OADs). Sulphonylureas (74%) and biguanides (50%) were the most commonly prescribed agents. Acarbose was used to treat 17% of patients and 1% were receiving insulin. GPs set glycaemic treatment goals for 44% of patients in the study. Fasting glycaemia was the primary goal for 37% of the total study population, and HbA(1c) levels for 21% of patients. Postprandial glycaemia was generally given as a secondary or tertiary goal. In conclusion, this study provides the most up-to-date epidemiological data for patients with type 2 diabetes in France.
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PMID:Epidemiological analysis of patients with Type 2 diabetes in France. 1111 85

The Diabetes Prevention Program (DPP) is a multicenter randomized controlled trial designed to test whether diet and exercise or medication can prevent or delay the onset of type 2 diabetes in persons with impaired glucose tolerance, who are at increased risk of the disease. This paper describes DPP recruitment methods, strategies, performance, and costs. The DPP developed an organizational structure for comprehensive management and continuous monitoring of recruitment efforts. The DPP utilized a variety of recruitment strategies, alone or in combination, and a stepped informed consent procedure leading to randomization. Studywide and clinic-specific recruitment data were monitored, analyzed, and used to modify recruitment approaches. DPP recruitment was completed slightly ahead of schedule, meeting goals for the proportion of women enrolled and nearly meeting goals for the proportion of racial/ethnic minorities. Clinics varied widely in the recruitment strategies they used, and these strategies also varied by participant age, gender, and race/ethnicity. Staff time devoted to recruitment averaged 86.8 hours per week per clinic, with the majority of effort by staff specifically assigned to recruitment. The number of staff hours required to recruit a participant varied by recruitment strategy. Recruitment cost (excluding staff cost) was about 1075 US dollars per randomized participant. The DPP experience offers lessons for those planning similar efforts: (1) a method for ongoing assessment and revision of recruitment strategies is valuable; (2) a range of recruitment strategies may be useful; (3) the most effective methods for recruiting potential subjects may vary according to the gender, age, and race/ethnicity of those individuals; (4) recruitment strategies vary in the amount of staff time required to randomize a participant; and (5) a stepped screening may make it easier to identify and recruit volunteers who understand the requirements of the study.
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PMID:The Diabetes Prevention Program: recruitment methods and results. 1194 42

Lipoprotein (a) is a new independent coronary risk factor, but the role of lipoprotein (a) in type 2 diabetes remains controversial. The objective of this study was to demonstrate the relationship between the level of lipoprotein (a) and the coronary artery diseases (CAD) in type 2 diabetes. Recruitment was carried out in 3 groups of patients: Group 1: 110 control subjects, Group 2: 115 diabetics (D), Group 3: 105 diabetics with CAD (DC). The mean age was, 51 + 7; 52 + 6; 56 + 6 respectively. Total cholesterol, triglyceride, HDL-C, LDL-C, Apo A-I, Apo B and lipoprotein (a) were measured for the patients. The Lp (a) level was significantly higher in the diabetic groups as compared to the controls (p < 0.05), but this level was different between D and DC: 312 + 232 vs 347.8 + (NS). However, when the Lp (a) level is higher than 300 mg/ml, there is a significant difference between DC and D (53% vs 42% p = 0.05). There is no correlation between Lp level and total cholesterol; however, there is a significant variation of Lp (a) level with LDL-C (r = -0.14, P = 0.01). There is a negative correlation between Lp (a) and HDL-C (r = -0.13, p = 0.03), Lp (a) and ApoA-I (r = - 0.11, p = 0.05); but there is a positive correlation between Lp (a) and ApoB (r = 0.14, p = 0.02). Lp(a) level higher than 300 mg/L constitutes a coronary risk factor in type 2 diabetes. This contributes, with the other lipid disorders, to the increase of the coronary risk factors in diabetes.
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PMID:[Lipoprotein (a) and ischemic heart diseases in patients with type 2 diabetes]. 1507 42

The purpose of this study was to evaluate the relationship of recruitment methods to enrollment status in Black women with type 2 diabetes screened for entry into a randomized clinical trial (RCT). Using a cross-sectional study design with convenience sampling procedures, data were collected on recruitment methods to which the women responded (N=236). Results demonstrated that the RCT had a moderate overall recruitment rate of 46% and achieved only 84% of its projected accrual goal (N=109). Chi-square analysis demonstrated that enrollment outcomes varied significantly according to recruitment methods (P=.05). Recruitment methods such as community health fairs (77.8%), private practice referrals (75.0%), participant referrals (61.5%), community clinic referrals (44.6%), community advertising and marketing (40.9%), and chart review (40.4%) demonstrated variable enrollment yields. Results confirm previous findings that indicate that Black Americans may be successfully recruited into research studies at moderate rates when traditional recruitment methods are enhanced and integrated with more culturally sensitive methods. Lessons learned are considered.
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PMID:Recruitment of black women with type 2 diabetes into a self-management intervention trial. 1706 53

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial aims to test whether a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) plus a fibrate is more efficacious in reducing cardiovascular events than a statin plus placebo in patients with type 2 diabetes mellitus with defined glycemic control. This is a blinded component in a 5,518-patient subset of the ACCORD cohort. These participants were randomized to either be (1) treated with simvastatin (titrated to 40 mg/day if necessary to achieve a goal low-density lipoprotein [LDL] cholesterol level of <2.59 mmol/L [100 mg/dL]) plus placebo or (2) treated to the same goal LDL cholesterol level with the statin plus active fenofibrate 160 mg/day or its bioequivalent (or 54 mg/day if the estimated glomerular filtration rate ranges from 30 to <50 mL/min per 1.73 m2). Setting an upper limit of LDL cholesterol qualifying for randomization excluded patients who would not likely achieve the LDL cholesterol goal. Recruitment for ACCORD began in January 2001, and follow-up is scheduled to end in June 2009. Since recruitment began, several clinical trials and consensus statements have been published that led to changes in the details of the lipid treatment algorithm and protocol. This report describes the design of the lipid protocol and modifications to the protocol during the course of the study in response to and in anticipation of these developments. The current protocol is designed to provide an ethically justifiable test of combined statin plus fibrate treatment consistent with the highest level of safety and lipid treatment standards of care.
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PMID:Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. 1759 26

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized, multicenter clinical trial using a double 2 x 2 factorial design in 10,251 participants with type 2 diabetes mellitus at high risk for cardiovascular disease (CVD) events. ACCORD is testing 3 complementary medical treatment strategies that may reduce high rates of major CVD morbidity and mortality in patients with type 2 diabetes. The ACCORD vanguard phase, conducted at 59 clinics in the United States and Canada, recruited 1,174 participants in 20 weeks from January through June 1, 2001, with a recruitment efficiency (R-factor) of 0.65. The recruitment strategies used in this vanguard phase were almost exclusively chart and database review within clinical practices and institutions. Recruitment for the main trial began in February 2003, involved 77 clinics, and resulted in an additional 9,077 participants by October 29, 2005 (total, 10,251). The R-factor during main trial recruitment was 0.96. Although new and refined recruitment strategies were formulated from the vanguard experience, the most powerful determinant of improved recruitment efficiency was the immediate start of enrollment by most clinics at the beginning of the main trial. Recruitment in the main trial required only a brief extension of 3 months and facilitated the nearly complete capture of the expected number of person-years of observation. Described herein are vanguard and main trial recruitment activities, including strategy implementation, screening procedures, randomization results, problems encountered, and lessons learned.
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PMID:Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. 1759 27

The glycemic index (GI) reflects the postprandial glucose response of carbohydrate-containing foods, and adoption of a lower-GI diet may be beneficial in diabetes management. The purpose of this study was to evaluate change in food-group intake by participants after completing an intervention that included instruction about carbohydrate and the GI using a quasi-experimental design. Recruitment occurred from February to August 2005 and September to December 2006. Individuals 40 to 70 years old with type 2 diabetes for 1 year or longer were randomly assigned to an immediate (n=55) or delayed (n=48) treatment group. A 9-week group-based intervention regarding the quantity and type of carbohydrate for diabetes management was provided. Three sets of 24-hour dietary recalls were used to assess food-group intake. Foods were divided into nine main food groups and 166 subgroups based on the Dietary Guidelines for Americans 2005 and the United States Department of Agriculture's Food Guide Pyramid. Analysis of variance was used to examine between-group differences and paired t test compared maintenance of change for the immediate group. Change in dietary GI was significantly different between groups upon completion of the intervention by the immediate group (P<0.05). Participants consumed significantly more servings of whole fruit and nonfat dairy products following the intervention and fewer servings of vegetable fats (all P<0.05). Only whole-fruit consumption significantly declined in the immediate group during the maintenance period (P<0.05). Nutrition education can facilitate adoption of a lower-GI diet among free-living people with diabetes. Maintaining dietary change likely requires further intervention and support.
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PMID:Change in food choices following a glycemic load intervention in adults with type 2 diabetes. 1916 61

Recruitment and retention of persons participating in research is one of the most significant challenges faced by investigators. Although incentives are often used to improve recruitment and retention, evidence suggests that the relationship of the patient to study personnel may be the single, most important factor in subject accrual and continued participation. Peplau's theory of interpersonal relations provides a framework to study the nurse-patient relationship during the research process. In this paper the authors provide a brief summary of research strategies that have been used for the recruitment and retention of subjects and an overview of Peplau's theory of interpersonal relations including its use in research studies. In addition, a discussion of how this theory was used for the successful recruitment and retention of women with type 2 diabetes who participated in a clinical trial using a nurse-delivered psychoeducational intervention for depression is addressed.
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PMID:Improving subject recruitment, retention, and participation in research through Peplau's theory of interpersonal relations. 2147 Oct 39


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