156 results on '"Colwell JA"'
Search Results
2. Aspirin for primary prevention of cardiovascular events in people with diabetes: a position statement of the American Diabetes Association, a scientific statement of the American Heart Association, and an expert consensus document of the American College of Cardiology Foundation.
- Author
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Pignone M, Alberts MJ, Colwell JA, Cushman M, Inzucchi SE, Mukherjee D, Rosenson RS, Williams CD, Wilson PW, and Kirkman MS
- Subjects
- American Heart Association, Aspirin adverse effects, Dose-Response Relationship, Drug, Humans, Platelet Aggregation Inhibitors adverse effects, Risk Factors, Societies, Medical, United States, Aspirin therapeutic use, Cardiovascular Diseases prevention & control, Diabetes Complications complications, Platelet Aggregation Inhibitors therapeutic use
- Published
- 2010
- Full Text
- View/download PDF
3. Aspirin for primary prevention of cardiovascular events in people with diabetes: a position statement of the American Diabetes Association, a scientific statement of the American Heart Association, and an expert consensus document of the American College of Cardiology Foundation.
- Author
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Pignone M, Alberts MJ, Colwell JA, Cushman M, Inzucchi SE, Mukherjee D, Rosenson RS, Williams CD, Wilson PW, and Kirkman MS
- Subjects
- American Heart Association, Diabetes Mellitus physiopathology, Humans, Societies, Medical, United States, Aspirin therapeutic use, Cardiovascular Diseases prevention & control, Diabetes Complications prevention & control, Diabetes Mellitus drug therapy, Platelet Aggregation Inhibitors therapeutic use
- Published
- 2010
- Full Text
- View/download PDF
4. Does aspirin use reduce cardiovascular risk in diabetes?
- Author
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Colwell JA
- Subjects
- Aspirin administration & dosage, Atherosclerosis epidemiology, Atherosclerosis etiology, Cardiovascular Diseases epidemiology, Cardiovascular Diseases etiology, Humans, Platelet Aggregation Inhibitors administration & dosage, Aspirin therapeutic use, Atherosclerosis complications, Atherosclerosis prevention & control, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Platelet Aggregation Inhibitors therapeutic use
- Abstract
The use of aspirin for the primary prevention of cardiovascular events in patients with type 2 diabetes mellitus is controversial. According to the findings of a Japanese trial, aspirin does not reduce the risk of cardiovascular events in this group of patients, unless they are aged 65 years and above.
- Published
- 2009
- Full Text
- View/download PDF
5. Racial disparities in trends for cardiovascular disease and procedures among hospitalized diabetic patients.
- Author
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Mountford WK, Lackland DT, Soule JB, Hunt KJ, Lipsitz SR, and Colwell JA
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- Aged, Aged, 80 and over, Cardiovascular Diseases complications, Cardiovascular Diseases surgery, Cardiovascular Surgical Procedures statistics & numerical data, Databases, Factual, Female, Healthcare Disparities, Hospitalization statistics & numerical data, Hospitalization trends, Humans, Length of Stay, Linear Models, Male, South Carolina epidemiology, Black or African American statistics & numerical data, Cardiovascular Diseases ethnology, Diabetes Complications ethnology, Diabetes Mellitus ethnology, White People statistics & numerical data
- Abstract
Methods: To determine if racial differences exist for trends in diabetes-related cardiovascular disease (CVD) hospitalization rates, we analyzed data from an inpatient hospital discharge database maintained by the South Carolina Office of Research and Statistics. All hospitalizations involving a diagnosis of diabetes were collected from 1996 through 2003. International Classification of Diseases codes were used to determine diagnosis for diabetes, acute myocardial infraction (AMI), stroke, and other CVD outcomes. Multiple linear regression was performed to model the age-standardized rates during the study period. An interaction parameter for race and discharge year was used in the models to determine if the trend slopes varied between African Americans and Caucasians., Results: The diabetes-related hospitalization rates for AMI and stroke declined for both race groups. Although the stroke rates for African Americans were consistently higher than those for Caucasians, the African American trend declined more sharply (P=.027). AMI rates showed sharper declines among Caucasians (P<.001). Rates of CVD procedures (percutaneous transluminal coronary angioplasty and coronary artery bypass graft) were two to three times greater among Caucasians. Cardiomyopathy rates were significantly greater among African Americans and showed a larger increasing trend (P<.001), and findings for congestive heart failure trends were similar (P<.001)., Conclusions: Diabetes-related CVD rates and trends vary considerably by race. Rates of AMI and stroke declined in African Americans and Caucasians from 1996 through 2003, while other CVD rates increased. Further research is needed to understand the underlying components of these disparities.
- Published
- 2008
6. Diabetes-related lower extremity amputation rates fall significantly in South Carolina.
- Author
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Mountford WK, Soule JB, Lackland DT, Lipsitz SR, and Colwell JA
- Subjects
- Adult, Black or African American statistics & numerical data, Aged, Diabetic Foot epidemiology, Female, Health Surveys, Hospitalization statistics & numerical data, Humans, International Classification of Diseases statistics & numerical data, Linear Models, Male, Middle Aged, Patient Education as Topic, Prevalence, Risk Factors, Rural Population statistics & numerical data, Sex Distribution, South Carolina epidemiology, United States epidemiology, Urban Population statistics & numerical data, White People statistics & numerical data, Amputation, Surgical statistics & numerical data, Diabetic Foot surgery
- Abstract
Background: The aims of this study are to compare the diabetes-related lower extremity amputation (LEA) rate trend in South Carolina (SC) to that of the United States (US) and to determine changes in LEA rates in SC according to age, race, gender, and amputation, Methods: National Hospital Discharge Survey (NHDS) and SC hospital discharge data for 1996 to 2002 were analyzed. ICD-9-CM codes identified all diabetic patients and occurrences of LEA. Linear regression was used to compare the LEA rate trends between SC and the US., Results: LEA rates are decreasing throughout the study period. The slope is greater in SC compared with US (US slope = -0.00082; SC slope = -0.0015; P = 0.002), signifying a decrease in LEA rates of 1.5/1000 per year in SC and 0.8/1000 per year in the US. Furthermore, LEA rate decreases in SC are significant throughout all ages, races, genders, and amputation levels., Conclusions: Diabetes-related LEA rates are decreasing in SC more rapidly than in the US. Ongoing community-level education may be assisting in the favorable trends.
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- 2007
- Full Text
- View/download PDF
7. An appraisal of aspirin therapy in diabetes.
- Author
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Colwell JA
- Subjects
- Adult, Drug Resistance, Humans, Aspirin therapeutic use, Coronary Disease prevention & control, Diabetic Angiopathies prevention & control, Platelet Aggregation Inhibitors therapeutic use
- Published
- 2006
- Full Text
- View/download PDF
8. Aspirin for the primary prevention of cardiovascular events.
- Author
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Colwell JA
- Abstract
There is significant evidence that low-dose aspirin is effective in preventing the first myocardial infarction in men and ischemic stroke in women. There is also an increased risk for major gastrointestinal tract hemorrhage and a suggestive, but nonsignificant, increase in the risk for hemorrhagic stroke. If there is a history of ulcer disease or upper-gastrointestinal tract bleeding, Helicobacter pylori should be eradicated (if present) and a proton pump inhibitor used with aspirin therapy. In conclusion, the benefits of low-dose aspirin (75-162 mg/day) in the prevention of myocardial infarction in men and thrombotic stroke in women generally outweigh the risks of serious bleeding in adults with a coronary heart disease risk >1% per year or >1% in 10 years., ((c) 2006 Prous Science. All rights reserved.)
- Published
- 2006
9. Evidence of nephropathy and peripheral neuropathy in US adults with undiagnosed diabetes.
- Author
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Koopman RJ, Mainous AG 3rd, Liszka HA, Colwell JA, Slate EH, Carnemolla MA, and Everett CJ
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- Adult, Aged, Albuminuria diagnosis, Albuminuria epidemiology, Diabetic Nephropathies diagnosis, Diabetic Neuropathies diagnosis, Female, Humans, Male, Middle Aged, Nutrition Surveys, Prevalence, Sensation, United States epidemiology, Diabetic Nephropathies epidemiology, Diabetic Neuropathies epidemiology
- Abstract
Purpose: Nearly one third of diabetes cases in the United States is undiagnosed, with mounting evidence that complications accrue even before clinical diagnosis. We wanted to determine whether persons with undiagnosed diabetes have signs of nephropathy and peripheral neuropathy., Methods: We examined the prevalence of positive screening tests for nephropathy and peripheral neuropathy in adults aged > or = 40 years with undiagnosed diabetes using secondary analysis of survey and examination data from the population-based United States National Health and Nutrition Examination Survey 1999-2002. We defined a positive screening test for nephropathy as a spot urine albumin-creatinine ratio > 30.0 mg/g, representing at least microalbuminuria. We defined > or = 1 insensate area on Semmes-Weinstein monofilament testing as a positive finding for neuropathy. Undiagnosed diabetes was defined as a combination of no history of diagnosed diabetes and a measured fasting glucose > or = 126 mg/dL. We used SUDAAN for chi2 and regression analyses., Results: The prevalence of a positive test when screening for nephropathy among those with undiagnosed diabetes was 26.5% compared with 7.1% in those with no diabetes (chi2, P <.01). After adjusting for age and diagnosed or undiagnosed hypertension, the association of undiagnosed diabetes with nephropathy persisted (odds ratio = 2.35; 95% confidence interval, 1.38-4.01). For peripheral neuropathy, 21.5% with undiagnosed diabetes had positive screening tests compared with 10.1% with no diabetes (chi2, P <.01); however, this effect was not significant after adjustment for age. There was no significant difference in positive screening tests for nephropathy or neuropathy when comparing those with undiagnosed and diagnosed diabetes., Conclusions: A significant proportion of adults with undiagnosed diabetes have signs of nephropathy and peripheral neuropathy. These findings may influence policies about early screening for diabetes.
- Published
- 2006
- Full Text
- View/download PDF
10. Aspirin for the primary prevention of cardiovascular events.
- Author
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Colwell JA
- Subjects
- Aspirin administration & dosage, Aspirin adverse effects, Dose-Response Relationship, Drug, Humans, Meta-Analysis as Topic, Platelet Aggregation Inhibitors administration & dosage, Platelet Aggregation Inhibitors adverse effects, Platelet Aggregation Inhibitors therapeutic use, Practice Guidelines as Topic, Aspirin therapeutic use, Cardiovascular Diseases prevention & control
- Abstract
There is significant evidence that low-dose aspirin is effective in preventing the first myocardial infarction in men and ischemic stroke in women. There is also an increased risk for major gastrointestinal tract hemorrhage and a suggestive, but nonsignificant, increase in the risk for hemorrhagic stroke. If there is a history of ulcer disease or upper-gastrointestinal tract bleeding, Helicobacter pylori should be eradicated (if present) and a proton pump inhibitor used with aspirin therapy. In conclusion, the benefits of low-dose aspirin (75-162 mg/day) in the prevention of myocardial infarction in men and thrombotic stroke in women generally outweigh the risks of serious bleeding in adults with a coronary heart disease risk >1% per year or >1% in 10 years., ((c) 2006 Prous Science. All rights reserved.)
- Published
- 2006
- Full Text
- View/download PDF
11. Is aspirin effective in diabetic patients? Yes.
- Author
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Colwell JA
- Subjects
- Coronary Disease etiology, Coronary Disease prevention & control, Diabetes Complications drug therapy, Diabetes Complications prevention & control, Humans, Treatment Outcome, Aspirin therapeutic use, Diabetes Mellitus drug therapy
- Published
- 2005
- Full Text
- View/download PDF
12. Aspirin therapy in diabetes.
- Author
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Colwell JA
- Subjects
- Aspirin adverse effects, Female, Humans, Male, Stroke prevention & control, Aspirin therapeutic use, Diabetes Mellitus therapy, Diabetic Angiopathies prevention & control, Platelet Aggregation Inhibitors therapeutic use
- Published
- 2004
- Full Text
- View/download PDF
13. Antiplatelet agents for the prevention of cardiovascular disease in diabetes mellitus.
- Author
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Colwell JA
- Subjects
- Drug Therapy, Combination, Humans, Platelet Aggregation Inhibitors pharmacology, Practice Guidelines as Topic, Randomized Controlled Trials as Topic, Cardiovascular Diseases etiology, Cardiovascular Diseases prevention & control, Diabetes Complications, Platelet Aggregation Inhibitors therapeutic use
- Abstract
Patients with diabetes mellitus (DM) have accelerated atherothrombotic disease of coronary, cerebral, leg, and other vessels. The major cause of death is cardiovascular, and the risk for a myocardial infarction (MI) in a patient with DM who has never had a MI is the same as a nondiabetic individual who has already had one. In this paper, we review the major reasons for a prothrombotic state in patients with DM: alterations in the intrinsic coagulation and fibrinolytic systems and many abnormalities of platelet function. Increased platelet thromboxane production as well as activation of platelet receptors for fibrinogen and or adenosine diphosphate (ADP) are often present, and can be treated with aspirin (acetylsalicylic acid) and/or receptor blockers. Review of the major primary prevention trials in DM indicates that a significantly reduced risk for MI or major cardiovascular events may be obtained by enteric-coated aspirin, 81-325 mg/day. There is emerging consensus that this is recommended strategy in adult (aged >30 years) patients with DM who are at high vascular risk. Surveys suggest that this includes virtually every patient with type 2 DM in the US, as well as many patients with complicated type 1 DM. These recommendations are also appropriate for secondary prevention. Data supporting the use of clopidogrel as an alternative drug in the case of aspirin allergy or other contraindications are reviewed. Evidence is presented in support of using aspirin plus clopidogrel in acute coronary syndromes (ACS), and a meta-analysis of six trials of platelet glycoprotein (GP) IIb/IIIa inhibitors and aspirin in diabetic patients with ACS establishes this regimen as an effective choice. Although bleeding episodes are more common with combined antiplatelet therapy for ACS than for aspirin alone, the benefit of a significant reduction in 30-day mortality appears to outweigh the risk of major bleeding. It is concluded that major advances in our understanding of the prothrombotic state in DM have been made. Evidence from controlled clinical trials supports the use of enteric-coated aspirin, 81-325 mg/day, as a primary and a secondary prevention strategy in adults with DM with high vascular risk. In ACS, combination therapy with aspirin plus clopidogrel or alternatively, aspirin plus a platelet GP IIb/IIIa inhibitor is supported by prospective trial data. These approaches should be added to the other multifactorial preventive strategies directed at lowering the risk for major vascular events in patients with DM.
- Published
- 2004
- Full Text
- View/download PDF
14. Aspirin for primary prevention of cardiovascular events in diabetes.
- Author
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Colwell JA
- Subjects
- Humans, Aspirin therapeutic use, Cardiovascular Diseases prevention & control, Diabetic Angiopathies prevention & control, Platelet Aggregation Inhibitors therapeutic use
- Published
- 2003
- Full Text
- View/download PDF
15. The platelet in diabetes: focus on prevention of ischemic events.
- Author
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Colwell JA and Nesto RW
- Subjects
- Aspirin therapeutic use, Cardiovascular Diseases blood, Cardiovascular Diseases etiology, Cardiovascular Diseases prevention & control, Diabetes Mellitus physiopathology, Diabetic Angiopathies physiopathology, Humans, Platelet Aggregation Inhibitors therapeutic use, Blood Platelets physiology, Diabetes Mellitus blood, Diabetic Angiopathies blood, Ischemia prevention & control
- Abstract
Accelerated atherosclerosis and the increased risk of thrombotic vascular events in diabetes may result from dyslipidemia, endothelial dysfunction, platelet hyperreactivity, an impaired fibrinolytic balance, and abnormal blood flow. There is also a correlation between hyperglycemia and cardiovascular (CV) events. The importance of platelets in the atherothrombotic process has led to investigation of using antiplatelet agents to reduce CV risk. A meta-analysis conducted by the Antiplatelet Trialists' Collaboration demonstrated that aspirin reduced the risk of ischemic vascular events as a secondary prevention strategy in numerous high-risk groups, including patients with diabetes. Based on results from placebo-controlled randomized trials, the American Diabetes Association recommends low-dose enteric-coated aspirin as a primary prevention strategy for people with diabetes at high risk for CV events. Clopidogrel is recommended if aspirin allergy is present. There is occasionally a need for an alternative to aspirin or for additive antiplatelet therapy. Aspirin in low doses inhibits thromboxane production by platelets but has little to no effect on other sites of platelet reactivity. Agents such as ticlopidine and clopidogrel inhibit ADP-induced platelet activation, whereas the platelet glycoprotein (Gp) IIb/IIIa complex receptor antagonists block activity at the fibrinogen binding site on the platelet. These agents appear to be useful in acute coronary syndromes (ACSs) in diabetic and nondiabetic patients. A combination of clopidogrel plus aspirin was more effective than placebo plus standard therapy (including aspirin) in reducing a composite CV outcome in patients with unstable angina and non-ST segment elevation myocardial infarction. In a meta-analysis of six trials in diabetic patients with ACSs, intravenous GpIIb-IIIa inhibitors reduced 30-day mortality when compared with control subjects. Results from controlled prospective clinical trials justify the use of enteric-coated low-dose aspirin (81-325 mg) as a primary or secondary prevention strategy in adult diabetic individuals (aged >30 years) at high risk for CV events. Recent studies support the use of clopidogrel in addition to standard therapy, as well as the use of GpIIb-IIIa inhibitors in ACS patients.
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- 2003
- Full Text
- View/download PDF
16. Aspirin therapy in diabetes.
- Author
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Colwell JA
- Subjects
- Aspirin adverse effects, Humans, Meta-Analysis as Topic, Quality Assurance, Health Care, Safety, United States, Aspirin therapeutic use, Diabetes Mellitus drug therapy, Diabetic Angiopathies prevention & control
- Published
- 2003
- Full Text
- View/download PDF
17. Hemoglobin A1c is not the only issue.
- Author
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Colwell JA
- Subjects
- Humans, Cardiovascular Diseases prevention & control, Diabetes Mellitus blood, Diabetes Mellitus therapy, Diabetic Angiopathies prevention & control, Glycated Hemoglobin analysis
- Published
- 2002
- Full Text
- View/download PDF
18. Treatment for the procoagulant state in type 2 diabetes.
- Author
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Colwell JA
- Subjects
- Anti-Inflammatory Agents, Non-Steroidal pharmacology, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Aspirin pharmacology, Aspirin therapeutic use, Blood Coagulation Disorders drug therapy, Blood Coagulation Disorders physiopathology, Blood Platelets drug effects, Blood Platelets physiology, Diabetes Mellitus physiopathology, Female, Fibrinolysis drug effects, Fibrinolysis physiology, Humans, Hypoglycemic Agents pharmacology, Hypoglycemic Agents therapeutic use, Male, Plasminogen Activator Inhibitor 1 physiology, Blood Coagulation Disorders complications, Diabetes Mellitus blood
- Abstract
A procoagulant state has been found to exist in diabetes mellitus. There may be activation of the intrinsic coagulation system, decreased fibrinolytic activity, or alterations in platelet function. Intensive glycemic control with insulin is effective in reducing the impact of this procoagulant state by favorably affecting all three components of the system. Decreased fibrinolytic activity, as influenced by plasma PAI-1 levels, may be favorably affected by weight loss, exercise, a low-GI diet, or by metformin, thiazolidinediones, gemfibrozil, and ACE inhibitor therapy. Insulin has variable effects on plasma PAI-1 activity. Estrogens will lower the elevated PAI-1 levels seen in the menopausal state. Collaborative trial evidence supports the use of low-dose aspirin as a primary or secondary prevention strategy in diabetic persons who are at high cardiovascular risk. A recent study suggests that this category includes virtually every type 2 diabetic individual in the United States. The American Diabetes Association recommends enteric-coated aspirin, 81 to 325 mg/day, as the first choice. In the case of aspirin allergy, clopidrogel is an alternate choice. Thus, recognition of and therapy for a procoagulant state in diabetes mellitus is likely to result in a decrease in the atherothrombotic events that characterize the later stages of this disease.
- Published
- 2001
- Full Text
- View/download PDF
19. Aspirin therapy in diabetes is underutilized.
- Author
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Colwell JA
- Subjects
- Aspirin administration & dosage, Cardiovascular Diseases prevention & control, Diabetic Angiopathies prevention & control, Humans, Aspirin therapeutic use, Diabetes Complications
- Published
- 2001
- Full Text
- View/download PDF
20. Dental endosseous implant assessments in a type 2 diabetic population: a prospective study.
- Author
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Olson JW, Shernoff AF, Tarlow JL, Colwell JA, Scheetz JP, and Bingham SF
- Subjects
- Adult, Age Factors, Aged, Blood Glucose analysis, Dental Implants, Dental Prosthesis Design, Dental Prosthesis, Implant-Supported, Dental Restoration Failure, Denture, Overlay, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 prevention & control, Follow-Up Studies, Glycated Hemoglobin analysis, Humans, Jaw, Edentulous rehabilitation, Jaw, Edentulous surgery, Male, Mandible surgery, Middle Aged, Osseointegration, Prospective Studies, Regression Analysis, Smoking physiopathology, Time Factors, Treatment Outcome, Wound Healing, Dental Implantation, Endosseous, Diabetes Mellitus, Type 2 physiopathology
- Abstract
Diabetes mellitus, a prevalent disorder worldwide, is associated with systemic adverse sequelae, such as wound healing alterations, which may affect osseointegration of dental implants. This prospective multicenter study assessed the success of 2-stage endosseous root-form implants (3 different implant systems) placed in the mandibular symphysis of 89 male type 2 diabetic subjects. The implants were uncovered approximately 4 months after placement, restored with an implant-supported, Hader bar clip-retained overdenture, and maintained at scheduled follow-up data collection examinations for 60 months after loading. Sixteen (9.0%) of the 178 implants failed. Life table methods calculated implant survival at approximately 88%, from prosthesis placement through the 60-month follow-up, and at approximately 90% from implant placement through the observation period. No implants failed between surgical placement and uncovering, 5 failed at uncovering, 7 failed after uncovering before prosthesis placement, and 4 failed after prosthesis placement. Fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) values were determined before implant placement (baseline) and approximately 4 months later at surgical uncovering (follow-up). The 5-year implant outcomes (successes versus failures) were analyzed against the following predictor variables: (1) baseline and follow-up FPG values, (2) baseline and follow-up HbA1c values, (3) subject age, (4) duration of diabetes (years), (5) baseline diabetic therapy, (6) smoking history, and (7) implant length. Regression analysis found only duration of diabetes (P < .025) and implant length (P < .001) to be statistically significant predictors of implant failure. There was no statistically significant difference in failure rates between the 3 different implant systems used. This study supports the use of dental implants in type 2 diabetic patients.
- Published
- 2000
21. Effect of intensive glycemic control on microalbuminuria in type 2 diabetes. Veterans Affairs Cooperative Study on Glycemic Control and Complications in Type 2 Diabetes Feasibility Trial Investigators.
- Author
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Levin SR, Coburn JW, Abraira C, Henderson WG, Colwell JA, Emanuele NV, Nuttall FQ, Sawin CT, Comstock JP, and Silbert CK
- Subjects
- Adult, Aged, Blood Glucose Self-Monitoring, Creatinine urine, Diabetes Mellitus, Type 2 blood, Drug Administration Schedule, Exercise, Follow-Up Studies, Glycated Hemoglobin analysis, Humans, Hypoglycemic Agents therapeutic use, Male, Middle Aged, Smoking Cessation, Time Factors, Albuminuria, Blood Glucose metabolism, Diabetes Mellitus, Type 2 therapy, Diabetes Mellitus, Type 2 urine, Insulin therapeutic use
- Abstract
Objective: Microalbuminuria can reflect the progress of microvascular complications and may be predictive of macrovascular disease in type 2 diabetes. The effect of intensive glycemic control on microalbuminuria in patients in the U.S. who have had type 2 diabetes for several years has not previously been evaluated., Research Design and Methods: We randomly assigned 153 male patients to either intensive treatment (INT) (goal HbA(1c) 7.1%) or to standard treatment (ST) (goal HbA(1c) 9.1%; P = 0.001), and data were obtained during a 2-year period. Mean duration of known diabetes was 8 years, mean age of the patients was 60 years, and patients were well matched at baseline. We obtained 3-h urine samples for each patient at baseline and annually and defined microalbuminuria as an albumin:creatinine ratio of 0.03-0.30. All patients were treated with insulin and received instructions regarding diet and exercise. Hypertension and dyslipidemia were treated with similar goals in each group., Results: A total of 38% of patients had microalbuminuria at entry and were evenly assigned to both treatment groups. INT retarded the progression of microalbuminuria during the 2-year period: the changes in albumin:creatinine ratio from baseline to 2 years of INT versus ST were 0.045 vs. 0.141, respectively (P = 0.046). Retardation of progressive urinary albumin excretion was most pronounced in those patients who entered the study with microalbuminuria and were randomized to INT. Patients entering with microalbuminuria had a deterioration in creatinine clearance at 2 years regardless of the intensity of glycemic control. In the group entering without microalbuminuria, the subgroup receiving ST had a lower percentage of patients with a macrovascular event (17%) than the subgroup receiving INT (36%) (P = 0.03). Use of ACE inhibitors or calcium-channel blockers was similarly distributed among the groups., Conclusions: Intensive glycemic control retards microalbuminuria in patients who have had type 2 diabetes for several years but may not lessen the progressive deterioration of glomerular function. Increases in macrovascular event rates in the subgroup entering without albuminuria who received INT remain unexplained but could reflect early worsening, as observed with microvascular disease in the Diabetes Control and Complications Trial.
- Published
- 2000
- Full Text
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22. Two years of intensive glycemic control and left ventricular function in the Veterans Affairs Cooperative Study in Type 2 Diabetes Mellitus (VA CSDM).
- Author
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Pitale SU, Abraira C, Emanuele NV, McCarren M, Henderson WG, Pacold I, Bushnell D, Colwell JA, Nuttall FQ, Levin SR, Sawin CT, Comstock JP, and Silbert CK
- Subjects
- Blood Pressure, Diabetes Mellitus, Type 2 blood, Drug Therapy, Combination, Follow-Up Studies, Glycated Hemoglobin analysis, Humans, Insulin therapeutic use, Male, Middle Aged, Radionuclide Ventriculography, Sulfonylurea Compounds therapeutic use, Time Factors, Blood Glucose metabolism, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 physiopathology, Hypoglycemic Agents therapeutic use, Ventricular Function, Left
- Abstract
Objective: The Veterans Affairs Cooperative Study in Type 2 Diabetes Mellitus (VA CSDM) was a multicenter randomized prospective study of 153 male type 2 diabetic patients to assess the ability to sustain clinically significant glycemic separation between intensive and standard treatment arms. A trend toward an excess of combined cardiovascular events in the intensive treatment arm of this trial was reported earlier. The present analysis was done to evaluate the effect of 2 years of intensive glycemic control on the left ventricular (LV) function., Research Design and Methods: The patients were randomized to intensive step treatment with insulin alone or with sulfonylurea (intensive treatment arm [INT], n = 75) or to standard once-daily insulin injection (standard treatment arm [STD], n = 78) treatment. A total of 136 patients (standard treatment arm [STD], n = 70; INT, n = 66) had radionuclide ventriculography at entry and at 24 months for the assessment of LV function., Results: There was no difference in the mean LV ejection fraction (at entry: STD 57.1+/-9.51%; INT 58.1+/-8.7%; at 24 months: STD 57.3+/-10.8%, INT 59.5+/-10.7%), peak filling rate (at entry: STD 2.6+/-0.7 end diastolic volume per second, INT 2.4+/-0.8 end diastolic volume per second; at 24 months: STD 2.7+/-1.0 end diastolic volume per second, INT 2.5+/-0.7 end diastolic volume per second), or time to peak filling rate (at entry: STD 195.3+/-69.5 ms, INT 185.6 +/-62.4 ms; at 24 months: STD 182.6+/-64.8 ms, INT 179.2+/-61.2 ms) between the 2 treatment arms. A subgroup analysis of 104 patients (STD, n = 53; INT, n = 51) that omitted individuals with intervening cardiac events/revascularization or a change in cardioactive medications also showed no difference in the LV function at entry and at 24 months between the 2 groups. Abnormal LV ejection fraction at baseline predicted cardiac events (interval between cardiac beats [RR] = 2.5)., Conclusions: Two years of intensive glycemic control does not affect the LV systolic or diastolic function in patients with type 2 diabetes.
- Published
- 2000
- Full Text
- View/download PDF
23. New legislation covers reimbursement and diabetes care guidelines.
- Author
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Colwell JA, Keisler D, Todd-Heckel E, Arnold P, and Jenkins C
- Subjects
- Humans, Practice Guidelines as Topic, South Carolina, Diabetes Mellitus, Reimbursement Mechanisms legislation & jurisprudence
- Published
- 2000
24. Aspirin and risk of hemorrhagic stroke.
- Author
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Colwell JA
- Subjects
- Aspirin therapeutic use, Humans, Platelet Aggregation Inhibitors therapeutic use, Risk, Aspirin adverse effects, Cerebral Hemorrhage etiology, Diabetes Mellitus physiopathology, Platelet Aggregation Inhibitors adverse effects
- Published
- 1999
- Full Text
- View/download PDF
25. Overview of the Diabetes Initiative of South Carolina.
- Author
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Colwell JA, Keisler D, Jenkins C, Boateng Y, Arnold P, Lackland D, Zheng D, Wheeler FC, Rosebrock G, and Smith SH
- Subjects
- Governing Board, Humans, Program Development, Schools, Medical, South Carolina, Diabetes Mellitus prevention & control, Legislation, Medical
- Abstract
Implementation is underway for many of these programs, and there are descriptions of activities elsewhere in this symposium. The Board recognizes that in dealing with the complications of a chronic disease like diabetes, many years of intense effort will be needed before significant results may be appreciated. Progress will be monitored regularly by the Surveillance Council and SCDCP/DHEC, and modifications of the plan will be made by the Board at intervals after review of the data. We are optimistic that over the next decade, this system will make a significant impact to reduce mortality, morbidity, and costs of diabetes, and the result will be an increased quality of life for people affected by diabetes in South Carolina.
- Published
- 1998
26. Diabetes research in South Carolina: past, present, and future.
- Author
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Willi SM, O'Rear D, Garvey WT, Colwell JA, Buse MG, Jaffa A, Lopes-Virella M, Wood D, Mayfield RK, Wallace P, Hermayer KL, Jenkins AJ, Lyons T, and Mayer-Davis E
- Subjects
- Diabetes Complications, Humans, Insulin Resistance, Research, South Carolina, Diabetes Mellitus prevention & control
- Abstract
Medical investigators in South Carolina have been on the "cutting edge" of diabetes research for a number of decades. Despite this fact, our state ranks second in the nation in diabetes prevalence, and diabetes complications are more severe here than anywhere else. It is from the efforts of these investigators that our hope for a brighter future comes. Through a concerted effort toward prevention, improvements in care, and investigation of the pathophysiology of diabetes and its complications, researchers may reduce the substantial burden of diabetes in our state and throughout the world.
- Published
- 1998
27. Response to intensive therapy steps and to glipizide dose in combination with insulin in type 2 diabetes. VA feasibility study on glycemic control and complications (VA CSDM).
- Author
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Abraira C, Henderson WG, Colwell JA, Nuttall FQ, Comstock JP, Emanuele NV, Levin SR, Sawin CT, and Silbert CK
- Subjects
- Adult, Aged, Blood Glucose metabolism, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 2 blood, Drug Administration Schedule, Drug Therapy, Combination, Fasting, Glipizide administration & dosage, Glipizide adverse effects, Humans, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Insulin administration & dosage, Insulin adverse effects, Male, Middle Aged, Prospective Studies, Diabetes Mellitus, Type 2 drug therapy, Glipizide therapeutic use, Glycated Hemoglobin analysis, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Objective: The feasibility study for the VA Cooperative Study on Glycemic Control and Complications in Type 2 Diabetes (VA CSDM) prospectively studied 153 insulin-requiring type 2 diabetes patients, randomized between an intensively treated arm and a standard treatment arm during a mean follow-up of 27 months. The glycemic response to each of the progressive, sequential phases of insulin treatment was assessed, along with the incidence of hypoglycemic reactions and the relative efficacy of different doses of glipizide in combination with fixed doses of insulin., Research Design and Methods: Five medical centers participated; half of the patients were assigned to the intensive treatment arm aiming for normal HbA1c levels. Age of patients was 60 +/- 6 years, duration of diabetes 8 +/- 3 years, and BMI 30.7 +/- 4 kg/m2. A four-step management technique was used, with patients moving to the next step if the operational goals were not met: Phase I, evening intermediate or long-acting insulin; phase II, added day-time glipizide; phase III, two injections of insulin alone; and phase IV, multiple daily insulin injections. Home glucose monitoring measurements were done twice daily and at 3:00 A.M. once a week. Hypoglycemic reactions and home glucose monitoring results were recorded and counted in each of the treatment phases., Results: Baseline HbA1c was 9.3 +/- 1.8%, and fasting plus serum glucose was 11.4 +/- 3.3 mmol/1. Fasting serum glucose fell to near normal in phase I, and remained so in the other treatment phases. An HbA1c separation of 2.1% between the arms was maintained during the course of the study, while the intensive arm kept HbA1c levels below 7.3% (P = 0.001). Most of the decrease in HbA1c occurred with one injection of insulin alone (phase I, -1.4%) or adding day-time glipizide (phase II, -1.9% compared with baseline). HbA1c did not decrease further after substituting two injections of insulin alone, with twice the insulin dose. Multiple daily injections resulted in an additional HbA1c fall (-2.4% compared with baseline). However, two-thirds of the patients were still on one or two injections a day at the end of the study. Changes in home glucose monitoring levels paralleled those of the HbA1c, as did the increments in number of reported hypoglycemic reactions, virtually all either "mild" or "moderate" in character. For the combination of glipizide and insulin (phase II), the only significant effect was obtained with daily doses up to 10 mg a day; there were no significant additional benefits with up to fourfold higher daily doses, and HbA1c levels had an upward trend with doses > 20 mg/day., Conclusions: A simple regime of a single injection of insulin, alone or with glipizide, seemed sufficient to obtain clinically acceptable levels of HbA1c for most obese, insulin-requiring type 2 diabetes patients. Further decrease of HbA1c demanded multiple daily injections at the expense of doubling the insulin dose and the rate of hypoglycemic events. In combination therapy, doses of glipizide > 20 mg/day offered no additional benefit.
- Published
- 1998
- Full Text
- View/download PDF
28. Ethnic differences in the glycemic response to exogenous insulin treatment in the Veterans Affairs Cooperative Study in Type 2 Diabetes Mellitus (VA CSDM).
- Author
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Agrawal L, Emanuele NV, Abraira C, Henderson WG, Levin SR, Sawin CT, Silbert CK, Nuttall FQ, Comstock JP, and Colwell JA
- Subjects
- Adult, Aged, Black People, Body Mass Index, C-Peptide blood, Diabetes Mellitus, Type 2 blood, Hospitals, Veterans, Humans, Male, Middle Aged, Sulfonylurea Compounds therapeutic use, United States, White People, Black or African American, Blood Glucose metabolism, Diabetes Mellitus, Type 2 drug therapy, Ethnicity, Glycated Hemoglobin analysis, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Objective: The Veterans Affairs Cooperative Study in Type 2 Diabetes Mellitus was conducted in NIDDM patients to determine if a significant difference in HbA1c could be achieved between groups receiving standard and intensive treatment. We observed differences in the response to exogenous insulin between African-Americans and other intensively treated patients. Therefore, we assessed the variations of response and correlated factors that might explain such differences., Research Design and Methods: One hundred fifty-three men aged 40-69 years with NIDDM for < or = 15 years were randomized to either the standard therapy (n = 78) or the intensive therapy (n = 75) arm. Of the 75 patients in the intensive therapy group, 57 completed the study on insulin therapy alone. Of these, 18 were African-Americans and 39 were non-African-Americans. We conducted an analysis of the data collected to determine differences in baseline characteristics, glycemic response, insulin requirement, body weight, exercise, and basal C-peptide level, factors that may explain a difference in response to insulin therapy., Results: Glycemic control improved in all patients with intensive insulin therapy. African-Americans achieved a greater improvement in HbA1c compared with non-African-Americans with a similar increment in insulin. This difference could not be explained by differences in body weight, activity, concomitant use of other medicines, or insulin-secretory capacity of the pancreas., Conclusions: We conclude that ethnic differences may exist in the response to insulin therapy. A knowledge of such differences may aid in achieving good glycemic control, especially since minorities have a greater prevalence of and burden from the microvascular complications of diabetes.
- Published
- 1998
- Full Text
- View/download PDF
29. A critical issue. Intensive insulin treatment and macrovascular disease.
- Author
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Abraira C, Colwell JA, Nuttall F, Emanuele N, Comstock J, Levin S, Sawin C, and Silbert C
- Subjects
- Cardiovascular Diseases epidemiology, Clinical Trials as Topic, Diabetes Mellitus drug therapy, Diabetes Mellitus physiopathology, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies prevention & control, Feasibility Studies, Humans, Obesity, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 drug therapy, Insulin therapeutic use
- Published
- 1998
- Full Text
- View/download PDF
30. Prevention of diabetes complications.
- Author
-
Colwell JA
- Subjects
- Biomarkers blood, Diabetic Angiopathies blood, Diabetic Neuropathies blood, Diabetic Retinopathy blood, Glycated Hemoglobin metabolism, Humans, Patient Education as Topic, Prognosis, Quality of Life, Diabetic Angiopathies prevention & control, Diabetic Neuropathies prevention & control, Diabetic Retinopathy prevention & control
- Abstract
Basic and clinical research findings have led to an increased understanding about diabetes and its complications. Therapeutic approaches are now based not only on predicted effects from epidemiologic, correlative, or retrospective analyses, but often on prospective intervention trials comparing a new form of therapy to the standard methods. While this database may never be complete, partially due to the complexity and variability of the diabetic state, we now have excellent data that allow the development of aggressive new guidelines for care. Much of the material presented here reflects the views of the American Diabetes Association, as included in a recent publication (1). These guidelines are under review by a number of other organizations and will be subject to modification for special situations. Thus, the terminology "guidelines," rather than "standards of care," is chosen to indicate the flexibility necessary in developing such recommendations for general usage.
- Published
- 1998
- Full Text
- View/download PDF
31. Preventive care among people with diabetes in biracial population.
- Author
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Zheng D, Learner M, Wheeler FC, Macera CA, Boateng Y, Shepard DM, and Colwell JA
- Subjects
- Adult, Aged, Female, Health Behavior, Humans, Logistic Models, Male, Middle Aged, Prevalence, South Carolina epidemiology, White People, Black or African American, Black People, Diabetes Mellitus ethnology, Preventive Health Services statistics & numerical data
- Published
- 1997
32. Multifactorial aspects of the treatment of the type II diabetic patient.
- Author
-
Colwell JA
- Subjects
- Arteriosclerosis epidemiology, Arteriosclerosis etiology, Arteriosclerosis prevention & control, Aspirin therapeutic use, Cardiovascular Diseases etiology, Cardiovascular Physiological Phenomena, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies etiology, Humans, Hyperglycemia complications, Hyperglycemia drug therapy, Hypoglycemic Agents therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Risk Factors, Thrombosis epidemiology, Thrombosis etiology, Thrombosis prevention & control, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 drug therapy, Diabetic Angiopathies epidemiology, Diabetic Angiopathies prevention & control
- Abstract
People with type II diabetes have a twofold to fourfold increased risk of dying from the complications of cardiovascular disease. Atherosclerosis and vascular thrombosis are major contributors. The increased risk is present before fasting hyperglycemia is seen. These individuals often have a sedentary life-style, poor physical conditioning, insulin resistance, centripetal obesity, hypertension, dyslipidemia, and a prothrombotic state. Chronic hyperglycemia is then added to these risk markers. Microalbuminuria may precede hyperglycemia in type II diabetes, occurs in 30% to 40% of these individuals after diabetes is established, and is a predictor of cardiovascular events. Early intervention in high-risk individuals may delay or prevent fasting hyperglycemia. An all-inclusive approach that focuses on early risk factor (or marker) identification and management to prevent or delay accelerated atherosclerosis and thrombosis in type II diabetes is an attractive strategy. However, the database to support this strategy is limited. In particular, large-scale prospective trial data are not available to support the concept of intensive glycemic regulation to prevent progression of macrovascular disease in type II diabetes. This is in contrast to the situation regarding microvascular disease of the eyes and kidneys. Recently, indirect data of a correlative nature have emerged, and short- and long-term prospective trials at early and late stages of type II diabetes are now being reported. These studies are analyzed and interpreted in this report. In contrast, the database to support an intensive antiplatelet regimen to prevent vascular thrombotic events in people with type II diabetes is large, and these studies are reviewed. They are of a type and magnitude to allow definite recommendations for aspirin therapy in type II diabetes. Aggressive therapy directed at hypertension, hyperlipidemia, and elevated urinary albumin in people with type II diabetes appears to be indicated. Increased attention to the multifactorial aspects of treatment of the type II diabetic patient is needed. Our present challenge is to translate these findings for patients and primary health care providers so that effective actions may be implemented.
- Published
- 1997
- Full Text
- View/download PDF
33. Elevated plasma homocysteine and diabetic vascular disease.
- Author
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Colwell JA
- Subjects
- Diabetes Mellitus, Type 1 blood, Humans, Diabetes Mellitus, Type 1 complications, Diabetic Angiopathies blood, Homocysteine blood
- Published
- 1997
- Full Text
- View/download PDF
34. Controlling type 2 diabetes: are the benefits worth the costs?
- Author
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Colwell JA
- Subjects
- Blood Glucose, Cost of Illness, Cost-Benefit Analysis, Diabetes Mellitus, Type 2 economics, Diabetes Mellitus, Type 2 physiopathology, Disease Management, Humans, Insulin adverse effects, Practice Guidelines as Topic, Diabetes Mellitus, Type 2 drug therapy, Glycated Hemoglobin metabolism, Insulin therapeutic use, Outcome Assessment, Health Care
- Published
- 1997
35. Aspirin therapy in diabetes.
- Author
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Colwell JA
- Subjects
- Aspirin pharmacology, Blood Platelets drug effects, Blood Platelets physiology, Diabetes Complications, Humans, Primary Prevention, Aspirin therapeutic use, Cardiovascular Diseases prevention & control, Diabetes Mellitus prevention & control
- Published
- 1997
- Full Text
- View/download PDF
36. Pharmacological strategies to prevent macrovascular disease in NIDDM.
- Author
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Colwell JA
- Subjects
- Humans, Hyperglycemia complications, Arteriosclerosis prevention & control, Diabetes Mellitus, Type 2 drug therapy, Diabetic Angiopathies prevention & control, Thrombosis prevention & control
- Abstract
The pathogenesis of atherosclerosis and vascular thrombosis in NIDDM is reviewed. Evidence that suggests a role for chronic hyperglycemia, in association with other vascular risk markers, is presented. Based on this framework, a multifactorial approach to the prevention of progression of macrovascular disease in NIDDM is discussed. Results from a recent consensus conference sponsored by the American Diabetes Association regarding approaches to glycemic regulation in people with NIDDM are reviewed. It is concluded that preventive approaches will materially alter the course of macrovascular disease, reduce health care costs, and improve the quality of life for people with NIDDM.
- Published
- 1997
- Full Text
- View/download PDF
37. Aspirin therapy in diabetes mellitus.
- Author
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Colwell JA
- Subjects
- Aspirin adverse effects, Diabetes Mellitus, Type 1 physiopathology, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies epidemiology, Gastrointestinal Hemorrhage chemically induced, Gastrointestinal Hemorrhage prevention & control, Humans, Placebos, Platelet Aggregation Inhibitors adverse effects, Risk Factors, Tablets, Enteric-Coated, Aspirin therapeutic use, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 2 drug therapy, Diabetic Angiopathies prevention & control, Platelet Aggregation Inhibitors therapeutic use
- Published
- 1997
38. Should we use intensive insulin therapy after oral agent failure in type II diabetes?
- Author
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Colwell JA
- Subjects
- Administration, Oral, Albuminuria, Angiotensin-Converting Enzyme Inhibitors therapeutic use, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies epidemiology, Diabetic Angiopathies mortality, Diabetic Neuropathies prevention & control, Diabetic Retinopathy prevention & control, Glycated Hemoglobin analysis, Humans, Hypoglycemic Agents administration & dosage, Morbidity, Risk Factors, Treatment Failure, Diabetes Mellitus, Type 2 drug therapy, Diabetic Angiopathies prevention & control, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Published
- 1996
- Full Text
- View/download PDF
39. Intensive insulin therapy in type II diabetes: rationale and collaborative clinical trial results.
- Author
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Colwell JA
- Subjects
- Arteriosclerosis prevention & control, Aspirin therapeutic use, Blood Glucose metabolism, Diabetic Angiopathies prevention & control, Dose-Response Relationship, Drug, Humans, Hyperglycemia complications, Male, Thrombosis prevention & control, Diabetes Mellitus, Type 2 drug therapy, Insulin administration & dosage
- Abstract
The rationale for intensive insulin therapy and results from major clinical trials in diabetes are reviewed. The Diabetes Control and Complications Trial (DCCT) has shown that intensive insulin therapy will prevent or delay the onset of retinopathy, nephropathy, and neuropathy in type I diabetes. The University Group Diabetes Program (UGDP) and the U.K. Prospective Diabetes Study (UKPDS) have addressed the issue of insulin versus oral agent or diet therapy in people with recently diagnosed type II diabetes. The UGDP showed that effective glycemic control could be achieved with intensive insulin therapy, but no effect on vascular end points was seen. Early data from the UKPDS also suggest that intensive insulin therapy may be more effective in lowering HbA1c toward normal than oral agents or diet. A pressing clinical problem is the question of the use of intensive insulin therapy in type II diabetic individuals who remain hyperglycemic despite pharmacological therapy. A Veterans Affairs Cooperative Study explored the feasibility of using intensive insulin therapy in 153 male type II diabetic patients with these characteristics. A 2% lowering of HbA1c was seen, with no increase in weight gain or in hypoglycemia. However, 40 of 153 patients (26.1%) had cardiovascular events during the 27-month trial; no difference in cardiovascular event rates was seen between the two treatment groups. A long-term multicenter collaborative trial is needed to assess the benefit:risk ratio of intensive insulin therapy for type II diabetic patients in whom pharmacological therapy failed to provide glycemic management.
- Published
- 1996
- Full Text
- View/download PDF
40. The feasibility of intensive insulin management in non-insulin-dependent diabetes mellitus. Implications of the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM.
- Author
-
Colwell JA
- Subjects
- Adult, Diabetes Mellitus, Type 2 blood, Drug Administration Schedule, Feasibility Studies, Glipizide therapeutic use, Glycated Hemoglobin metabolism, Hospitals, Veterans, Humans, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Male, Middle Aged, Treatment Outcome, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Objective: To review the results from the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM (VACSDM) and to discuss the implications of the results from this feasibility trial., Design: A randomized clinical trial comprising 153 men with non-insulin-dependent diabetes mellitus (NIDDM) who remained hyperglycemic on usual pharmacologic therapy. Patients were randomized into two groups receiving either standard or intensive insulin therapy and were followed for 27 months., Setting: Five Veterans Affairs medical centers., Patients: 153 men with NIDDM, aged 40 to 69 years, who had hemoglobin A1c (HbA1c) levels of greater than 6.55% while receiving sulfonylurea or insulin therapy., Intervention: Standard insulin therapy was one or two insulin injections daily. Intensive insulin therapy was done using a stepwise approach: 1) evening intermediate or long-acting insulin; 2) addition of daytime glipizide; 3) insulin twice daily, with no glipizide; and 4) insulin three to four times daily, with no glipizide., Measurements: Fasting blood glucose and HbA1c levels, retinopathy, lipid and urinary albumin levels, cardiovascular events, hypoglycemia, and body mass index., Results: In the intensive group, the HbA1c level fell 2.07 percentage points; the mean HbA1c level was 7.3% from 6 months onward. The standard group experienced little change. These changes occurred without significant weight gain and with a very low rate of severe hypoglycemia. Sixteen patients (20.5%) in the standard group and 24 patients (32%) in the intensive group had cardiovascular events (P = 0.1)., Conclusions: It is feasible to achieve excellent glycemic control in men with NIDDM in whom standard pharmacologic therapy has failed. The benefit/risk ratio of intensive insulin management in this patient group is not established and has been made the subject of a long-term prospective clinical trial.
- Published
- 1996
- Full Text
- View/download PDF
41. Forum Two: Unanswered research questions about metabolic control in non-insulin-dependent diabetes mellitus.
- Author
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Colwell JA and Clark CM Jr
- Subjects
- Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 complications, Female, Humans, Hyperglycemia blood, Hyperglycemia etiology, Male, Blood Glucose metabolism, Diabetes Mellitus, Type 2 therapy, Hyperglycemia prevention & control
- Abstract
The participants of Forum Two addressed the unanswered research questions about metabolic control and non-insulin-dependent diabetes mellitus (NIDDM). The most compelling issue was the effect of metabolic control on both the development and progression of macrovascular disease in patients with NIDDM. Associated questions that could be answered by a well-controlled clinical trial related to the goal of blood glucose control in NIDDM in the elderly and in persons with clinical vascular disease. The specific suggestion was a trial similar to the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM. Another important research issue that was discussed was the benefit of treating other risk factors such as hypertension and hyperlipidemia in diabetic patients. Yet another area discussed was the study of health services delivery to examine the best care-delivery methods for diabetes and other chronic diseases. Other areas of discussion centered on basic research, that is, the fundamental cause of insulin resistance and the genetics of NIDDM and the loss of protection against atherosclerosis in postmenopausal women with diabetes.
- Published
- 1996
- Full Text
- View/download PDF
42. Release of platelet plasminogen activator inhibitor 1 in whole blood is increased in patients with type II diabetes.
- Author
-
Jokl R, Klein RL, Lopes-Virella MF, and Colwell JA
- Subjects
- Adult, Aged, Analysis of Variance, C-Peptide blood, Cholesterol blood, Cholesterol, HDL blood, Cholesterol, LDL blood, Cholesterol, VLDL blood, Cohort Studies, Diabetic Angiopathies blood, Female, Glycated Hemoglobin analysis, Humans, Hypertension blood, In Vitro Techniques, Insulin blood, Male, Middle Aged, Platelet Activation, Platelet Aggregation, Reference Values, Triglycerides blood, Blood Platelets physiology, Diabetes Mellitus, Type 2 blood, Plasminogen Activator Inhibitor 1 blood
- Abstract
Objective: To compare platelet plasminogen activator inhibitor 1 (PAI-1) release in type II diabetic patients and healthy control subjects., Research Design and Methods: We studied a group of 27 diabetic patients and a group of 16 nondiabetic control subjects. Whole-blood platelet aggregation, defined as a decrease in platelet count during shaking (180 rpm) of blood samples at 37 degrees C, and plasma PAI-1 antigen concentrations were measured in parallel at time 0, 7.5, 15, 30, 60, 120, and 180 min., Results: Platelet aggregation did not differ significantly between the two groups at any time period. However, the increase in plasma PAI-1 antigen concentration over basal levels at time 0 was higher for the group of diabetic patients when compared with their matched control subjects. The increment of PAI-1 antigen was 61.8 +/- 29.4 vs. 35.9 +/- 13.4 ng/ml (P < 0.005, means +/- SD) after 180 min for the diabetic and control subjects, respectively. Platelet PAI-1 release was correlated to very-low-density lipoprotein cholesterol and triglyceride plasma levels, but not to HbA1c levels., Conclusions: Platelets of patients with type II diabetes release significantly more PAI-1 than platelets of healthy subjects at the same level of platelet aggregation. This may contribute to enhanced thrombosis in diabetes.
- Published
- 1995
- Full Text
- View/download PDF
43. Veterans Affairs Cooperative Study on glycemic control and complications in type II diabetes (VA CSDM). Results of the feasibility trial. Veterans Affairs Cooperative Study in Type II Diabetes.
- Author
-
Abraira C, Colwell JA, Nuttall FQ, Sawin CT, Nagel NJ, Comstock JP, Emanuele NV, Levin SR, Henderson W, and Lee HS
- Subjects
- Aged, Albuminuria epidemiology, Animals, Biomarkers blood, Blood Glucose Self-Monitoring, Blood Pressure, Body Mass Index, Cholesterol blood, Cholesterol, HDL blood, Cholesterol, LDL blood, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Feasibility Studies, Glycated Hemoglobin analysis, Hospitals, Animal, Humans, Male, Middle Aged, Patient Selection, Quality Control, Smoking, Time Factors, Triglycerides blood, United States, Blood Glucose metabolism, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies epidemiology, Diabetic Retinopathy epidemiology, Glipizide therapeutic use, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
- Abstract
Objective: It is not clear whether intensive pharmacological therapy can be effectively sustained in non-insulin-dependent diabetes mellitus (NIDDM). The relative risks and benefits of intensive insulin therapy in NIDDM are not well defined. Accordingly, we designed a feasibility study that compared standard therapy and intensive therapy in a group of NIDDM men who required insulin due to sustained hyperglycemia., Research Design and Methods: A prospective trial was conducted in five medical centers in 153 men of 60 +/- 6 years of age who had a known diagnosis of diabetes for 7.8 +/- 4 years. They were randomly assigned to a standard insulin treatment group (one morning injection per day) or to an intensive therapy group designed to attain near-normal glycemia and a clinically significant separation of glycohemoglobin from the standard arm. A four-step plan was used in the intensive therapy group along with daily self-monitoring of glucose: 1) an evening insulin injection, 2) the same injection adding daytime glipizide, 3) two injections of insulin alone, and 4) multiple daily injections. Patient accrual and adherence, glycohemoglobin (HbA1c), side effects, and measurements of endpoints for a prospective long-term trial were assessed., Results: Accrual goals were met, mean follow-up time was 27 months (range 18-35 months), and patients kept 98.6% of scheduled visits. After 6 months, the mean HbA1c in the intensive therapy group was at or below 7.3% and remained 2% lower than the standard group for the duration of the trial. Most of the decrease in the mean HbA1c in the intensive group was obtained by a single injection of evening intermediate insulin, alone or with daytime glipizide. By the end of the trial, 64% of the patients had advanced to two or more injections of insulin a day, aiming for normal HbA1c. However, only a small additional fall in HbA1c was attained. Severe hypoglycemia was rare (two events per 100 patients per year) and not significantly different between the groups, nor were changes in weight, blood pressure, or plasma lipids. There were 61 new cardiovascular events in 40 patients and 10 deaths (6 due to cardiovascular causes)., Conclusions: Intense stepped insulin therapy in NIDDM patients who have failed glycemic control on pharmacological therapy is effective in maintaining near-normal glycemic control for > 2 years without excessive severe hypoglycemia, weight gain, hypertension, or dyslipidemia. Cardiovascular event rates are high at this stage of NIDDM. A long-term prospective trial is needed to assess the risk-benefit ratio of intensified treatment of hyperglycemia in NIDDM patients requiring insulin.
- Published
- 1995
- Full Text
- View/download PDF
44. Implants for type II diabetic patients: interim report. VA Implants in Diabetes Study Group.
- Author
-
Shernoff AF, Colwell JA, and Bingham SF
- Subjects
- Dental Prosthesis Design, Evaluation Studies as Topic, Follow-Up Studies, Humans, Male, Prospective Studies, Prosthesis Failure, Dental Care for Chronically Ill methods, Dental Implantation, Endosseous, Dental Implants, Diabetes Mellitus, Type 2
- Abstract
One hundred seventy-eight implants from three systems were placed in 89 type II diabetic patients at 13 Department of Veterans Affairs medical centers. Four failures (2.2 percent) were found at uncovering. The failure rate increased to 7.3 percent at the end of 1 year (nine additional failures). Study patients will be monitored for an additional 4 years. Initial results suggest that type II diabetic patients can be considered for dental implant therapy.
- Published
- 1994
- Full Text
- View/download PDF
45. Platelet plasminogen activator inhibitor 1 in patients with type II diabetes.
- Author
-
Jokl R, Laimins M, Klein RL, Lyons TJ, Lopes-Virella MF, and Colwell JA
- Subjects
- Blood Pressure, C-Peptide blood, Cholesterol blood, Diabetes Mellitus, Type 2 physiopathology, Diabetes Mellitus, Type 2 therapy, Diet, Diabetic, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemic Agents therapeutic use, In Vitro Techniques, Male, Middle Aged, Platelet Aggregation, Platelet Factor 4 analysis, Reference Values, Triglycerides blood, beta-Thromboglobulin analysis, Blood Platelets metabolism, Diabetes Mellitus, Type 2 blood, Plasminogen Activator Inhibitor 1 blood
- Abstract
Objective: To compare platelet plasminogen activator inhibitor 1 (PAI-1) concentration in type II diabetic patients and healthy control subjects., Research Design and Methods: We studied a group of 12 diabetic patients whose disease was controlled by diet or sulfonylurea therapy and a group of 17 nondiabetic control subjects. All subjects were free of clinically advanced vascular disease. PAI-1 antigen concentrations were measured in 5 x 10(8) isolated platelets, which were lysed by 1% Triton X-100., Results: Mean platelet PAI-1 was significantly higher in diabetic patients (264 +/- 83 ng/5 x 10(8) platelets) compared with control subjects (202 +/- 71 ng/5 x 10(8) platelets) (P < 0.05). A significant independent positive correlation was found between platelet PAI-1 concentrations and fasting plasma specific insulin levels in the diabetic patients (r = 0.63, P = 0.03)., Conclusions: These findings suggest that 1) a higher platelet PAI-1 concentration may contribute to enhanced thrombosis in type II diabetes and 2) megakaryocyte PAI-1 synthesis may be under the control of insulin.
- Published
- 1994
- Full Text
- View/download PDF
46. Is it time to introduce metformin in the U.S.?
- Author
-
Colwell JA
- Subjects
- Blood Glucose metabolism, Clinical Trials as Topic, Diabetes Mellitus, Type 2 blood, Humans, United States, Diabetes Mellitus, Type 2 drug therapy, Metformin therapeutic use
- Published
- 1993
- Full Text
- View/download PDF
47. Effects of gemfibrozil on triglyceride levels in patients with NIDDM. Hyperlipidemia in Diabetes Investigators.
- Author
-
Vinik AI and Colwell JA
- Subjects
- C-Peptide blood, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Double-Blind Method, Female, Glycated Hemoglobin analysis, Humans, Hyperlipidemias complications, Hyperlipidemias drug therapy, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Male, Middle Aged, Diabetes Mellitus, Type 2 blood, Gemfibrozil therapeutic use, Hyperlipidemias prevention & control, Triglycerides blood
- Abstract
Objective: Patients with NIDDM have a two- to fourfold increased risk of macrovascular disease. The constellation of elevated TGs and decreased HDL cholesterol are recognized as risk factors and constitute the major dyslipidemia in NIDDM. We therefore sought to determine if gemfibrozil (600 mg b.i.d.) was effective in correcting the dyslipidemia of NIDDM., Research Design and Methods: After 8 wk of placebo stabilization, 442 patients from 46 study centers were randomized to double-blind treatment, in a designated 2:1 ratio, 295 received gemfibrozil and 147 received placebo for 20 wk. The primary end point was plasma TG; secondary end points were TC, LDL cholesterol, VLDL cholesterol, HDL cholesterol, and HbA1c. No baseline differences were noted between groups in sex, age, weight, type of diabetic therapy, fasting plasma levels of TGs, HbA1c, or C-peptide. About two-thirds received oral hypoglycemic drugs, one-third insulin., Results: TG fell 26.4% in the gemfibrozil group and rose 7.4% in the placebo group (P < 0.023), by an intent-to-treat analysis. When patients who were noncompliant or with inadequate data were excluded, similar results were found--a 30.4% fall with gemfibrozil and a 4.8% increase with placebo (P < 0.0001). TG levels fell within 4 wk and remained low for 20 wk (P < 0.001). Mean HDL cholesterol rose by 4 wk and increased further at 12 wk (8-12%), P < 0.0001. TC fell. We observed a significant rise in LDL cholesterol in both gemfibrozil- and placebo-treated groups, with no significant differences between these groups. Changes in HbA1c were similar in gemfibrozil and placebo groups. No differences were observed in responses in groups treated with insulin and or oral hypoglycemic drugs. Overall AEs that were clinically important occurred in 6.1% in the gemfibrozil group vs. 2.0% in the placebo group (NS)., Conclusions: We conclude that gemfibrozil is an effective and safe agent in combating the dyslipidemia of NIDDM, irrespective of type of diabetic therapy.
- Published
- 1993
- Full Text
- View/download PDF
48. Vascular thrombosis in type II diabetes mellitus.
- Author
-
Colwell JA
- Subjects
- Diabetes Mellitus, Type 2 blood, Fibrinolysis, Humans, Risk Factors, Thrombosis epidemiology, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies physiopathology, Thrombosis physiopathology
- Published
- 1993
- Full Text
- View/download PDF
49. Antiplatelet drugs and prevention of macrovascular disease in diabetes mellitus.
- Author
-
Colwell JA
- Subjects
- Blood Platelets physiology, Cardiovascular Diseases blood, Cardiovascular Diseases etiology, Diabetes Mellitus blood, Humans, Cardiovascular Diseases prevention & control, Diabetes Complications, Platelet Aggregation Inhibitors therapeutic use
- Published
- 1992
- Full Text
- View/download PDF
50. Clinical trials of antiplatelet agents in diabetes mellitus: rationale and results.
- Author
-
Colwell JA
- Subjects
- Arteriosclerosis etiology, Clinical Trials as Topic, Diabetic Angiopathies prevention & control, Humans, Platelet Function Tests, Diabetic Angiopathies drug therapy, Platelet Aggregation Inhibitors therapeutic use
- Published
- 1991
- Full Text
- View/download PDF
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