Publications by authors named "David M Nathan"

Objective: To determine whether the relationship between average glucose (AG) levels and hemoglobin A1c (HbA1c) differs across racial/ethnic groups.

Research Design And Methods: We performed a prospective substudy of GRADE, a comparative effectiveness randomized trial conducted in 36 centers in the U.S.

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Article Synopsis
  • - The study aimed to replicate a previous finding that EDTA-based chelation therapy reduces cardiovascular disease (CVD) events in individuals with diabetes and a history of myocardial infarction (MI).
  • - Conducted at 88 sites in the US and Canada, the trial involved 959 participants who were randomly assigned to receive either chelation therapy or a placebo, with a median follow-up of 48 months.
  • - Results showed no significant difference in CVD events between the chelation group (35.6% experienced a primary event) and the placebo group (35.7%), indicating that chelation may not provide the hoped-for benefits in this population.
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Introduction: The Look AHEAD randomized clinical trial reported that an 8-year intensive lifestyle intervention (ILI) compared with diabetes support and education (DSE) in adults aged 45-76 years with type 2 diabetes and overweight/obesity delayed kidney disease progression. Here, we report long-term post-intervention follow-up for the trial's secondary outcome of kidney disease.

Research Design And Methods: We examined effects of ILI (n=2570) versus DSE (n=2575) on decline in estimated glomerular filtration rate (eGFR) to <45 mL/min/1.

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Objective: Mid-life cardiovascular risk factors are associated with later cognitive decline. Whether repetitive head injury among professional athletes impacts cardiovascular risk is unknown. We investigated associations between concussion burden and postcareer hypertension, high cholesterol, and diabetes among former professional American-style football (ASF) players.

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Background: The reduction in cardiovascular disease (CVD) events with edetate disodium (EDTA) in the Trial to Assess Chelation Therapy (TACT) suggested that chelation of toxic metals might provide novel opportunities to reduce CVD in patients with diabetes. Lead and cadmium are vasculotoxic metals chelated by EDTA. We present baseline characteristics for participants in TACT2, a randomized, double-masked, placebo-controlled trial designed as a replication of the TACT trial limited to patients with diabetes.

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  • The study aimed to evaluate the accuracy of continuous glucose monitoring (CGM) and hemoglobin A1c (HbA1c) in estimating average glucose levels (AG90) over 90 days for people with diabetes.
  • Researchers analyzed data from 985 CGM periods and assessed how average red blood cell age affects HbA1c readings.
  • Results showed that while using 14 days of CGM alone had a significant error, combining it with HbA1c measurements reduced this error, indicating that longer monitoring periods may yield more accurate glucose estimates.
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Aims: We analyzed the incidence of kidney disease in the Diabetes Prevention Program Outcomes Study (DPPOS) by originally randomized treatment group assignment: Intensive Lifestyle (ILS), Metformin (MET) or Placebo (PLB).

Methods: The current analyses used a time-to-event approach in which the primary outcome was kidney disease, ascertained as urine albumin-to-creatinine ratio (ACR) ≥ 3.39 mg/mmol (30 mg/g) or eGFR <45 mL/min/1.

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Article Synopsis
  • A committee evaluated the scientific evidence and developed evidence-based recommendations for laboratory tests used in diagnosing and managing diabetes mellitus, which were reviewed by various professional organizations.
  • Diagnosis of diabetes is primarily based on elevated glucose levels in blood or Hb A1c measurements, while patients can monitor their glycemic control using self-testing methods.
  • The guidelines highlight several testing methods, stating that some analytes currently offer minimal clinical value and are not recommended for use in practice.
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Background: Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially.

Approach: An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes.

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Background: Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially.

Approach: An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes.

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Background: Numerous laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in patients with diabetes.

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Article Synopsis
  • Younger adults with type 1 (T1D) and type 2 diabetes (T2D) face unique treatment challenges, particularly regarding health care coverage and access.
  • This study compared health care patterns and glycemic control (measured via HbA1c levels) among these individuals through data collected from two major national studies conducted between 2017 and 2019.
  • Results showed that T1D participants generally had better health care coverage and access to diabetes care than T2D participants, and lacking health coverage was linked to worse glycemic control.
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Objective: Kidney disease screening recommendations include annual urine testing for albuminuria after 5 years' duration of type 1 diabetes. We aimed to determine a simple, risk factor-based screening schedule that optimizes early detection and testing frequency.

Research Design And Methods: Urinary albumin excretion measurements from 1,343 participants in the Diabetes Control and Complications Trial and its long-term follow-up were used to create piecewise-exponential incidence models assuming 6-month constant hazards.

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Background: Data are lacking on the comparative effectiveness of commonly used glucose-lowering medications, when added to metformin, with respect to microvascular and cardiovascular disease outcomes in persons with type 2 diabetes.

Methods: We assessed the comparative effectiveness of four commonly used glucose-lowering medications, added to metformin, in achieving and maintaining a glycated hemoglobin level of less than 7.0% in participants with type 2 diabetes.

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Background: The comparative effectiveness of glucose-lowering medications for use with metformin to maintain target glycated hemoglobin levels in persons with type 2 diabetes is uncertain.

Methods: In this trial involving participants with type 2 diabetes of less than 10 years' duration who were receiving metformin and had glycated hemoglobin levels of 6.8 to 8.

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  • The study aims to identify the glycemic and non-glycemic factors leading to diabetic retinopathy (DR) in individuals before and after developing type 2 diabetes (T2D).
  • Fundus photography was utilized to assess DR in high-risk adults over a long follow-up period, revealing a notable prevalence of DR among those with T2D and factors like race, glucose levels, and weight influencing its occurrence.
  • Key findings indicated that higher HbA1c levels significantly increased the risk of DR, while American Indian race was linked to a lower prevalence of the condition compared to non-Hispanic Whites.
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Importance: The lower risk of cardiovascular disease (CVD) among women compared with men in the general population may be diminished among those with diabetes.

Objective: To evaluate cardiometabolic risk factors and their management in association with CVD events in women vs men with type 1 diabetes enrolled in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study.

Design, Setting, And Participants: This cohort study used data obtained during the combined DCCT (randomized clinical trial, conducted 1983-1993) and EDIC (observational study, conducted 1994 to present) studies through April 30, 2018 (mean [SD] follow-up, 28.

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Objective: Estimated time in range (eTIR) obtained from DCCT glucose profiles (pre- and postprandial and bedtime) was recently reported to be associated with microvascular outcomes and was recommended as a clinical trial outcome, but without consideration of HbA1c.

Research Design And Methods: The associations of eTIR with diabetic retinopathy and microalbuminuria were assessed without and with adjustment for HbA1c and baseline covariates.

Results: Adjusted for HbA1c and covariates, eTIR was marginally significantly associated with retinopathy in the full cohort (hazard ratio [HR] 1.

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Background: Lifestyle intervention and metformin have been shown to prevent diabetes; however, their efficacy in preventing cardiovascular disease associated with the development of diabetes is unclear. We examined whether these interventions reduced the incidence of major cardiovascular events over a 21-year median follow-up of participants in the DPP trial (Diabetes Prevention Program) and DPPOS (Diabetes Prevention Program Outcomes Study).

Methods: During DPP, 3234 participants with impaired glucose tolerance were randomly assigned to metformin 850 mg twice daily, intensive lifestyle or placebo, and followed for 3 years.

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Background: Intravenous edetate disodium-based infusions reduced cardiovascular events in a prior clinical trial. The Trial to Assess Chelation Therapy 2 (TACT2) will replicate the initial study design.

Methods: TACT2 is an NIH-sponsored, randomized, 2x2 factorial, double masked, placebo-controlled, multicenter clinical trial testing 40 weekly infusions of a multi-component edetate disodium (disodium ethylenediamine tetra-acetic acid, or NaEDTA)-based chelation solution and twice daily oral, high-dose multivitamin and mineral supplements in patients with diabetes and a prior myocardial infarction (MI).

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Importance: Increased risk of neurological and psychiatric conditions after traumatic brain injury (TBI) is well-defined. However, cardiovascular and endocrine comorbidity risk after TBI in individuals without these comorbidities and associations with post-TBI mortality have received little attention.

Objective: To assess the incidence of cardiovascular, endocrine, neurological, and psychiatric comorbidities in patients with mild TBI (mTBI) or moderate to severe TBI (msTBI) and analyze associations between post-TBI comorbidities and mortality.

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