Dataset Information

Glycemic and Cholesterol Control Versus Single-Goal Control in US Veterans with Newly Diagnosed Type 2 Diabetes: A Retrospective Observational Study.

ABSTRACT:

Introduction

A majority of patients with diabetes do not have levels of glycated hemoglobin (HbA1c) and low-density lipoprotein cholesterol (LDL-C) under control, either individually or in combination. The objective was to assess the clinical benefits and patient characteristics associated with dual-goal achievement [HbA1c <7% (53 mmol/mol) and LDL-C <100 mg/dL] versus only LDL-C goal achievement in adults with newly diagnosed type 2 diabetes.

Methods

Newly diagnosed patients with ≥2 measures of LDL-C and HbA1c were identified in the South Central Veterans Affairs Health Care Network (01/2004-06/2010). The index date was the first HbA1c assessment within 3 months of the first type 2 diabetes diagnosis. Multivariate Cox proportional hazards models were used to assess the association between time-varying goal achievement and post-index microvascular and cardiovascular complications. Patient characteristics associated with dual-goal achievement in the 7-12 months post-index were identified using a logistic regression.

Results

The sample included 16,829 patients. Compared with LDL-C goal achievement, dual-goal achievement was associated with lower risk of microvascular complications [hazard ratio (95% confidence interval): 0.69 (0.63, 0.76)]. Other outcomes did not differ between those two groups. Characteristics associated with dual-goal achievement (44.2% of patients) include prior dual-goal achievement, older age, and use of lipid-lowering drugs.

Conclusion

Dual-goal achievement in newly diagnosed type 2 diabetes is associated with a lower risk of microvascular complications versus only LDL-C goal achievement. Although dual-goal achievement rates are suboptimal, early and regular intervention will increase its likelihood.

Funding

Daiichi Sankyo, Inc., Parsippany, NJ, USA.

SUBMITTER: Shi L

PROVIDER: S-EPMC4575310 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundDietary modifications are crucial for managing newly diagnosed type 2 diabetes mellitus (T2DM) and preventing its health complications, but many patients fail to achieve clinical goals with diet alone. We sought to evaluate the clinical effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in individuals with newly diagnosed T2DM as compared to the commonly recommended Mediterranean-style (MED) diet.MethodsWe enrolled 23 adults with newly diagnosed T2DM (aged 53.5 ± 8.9 years, 48% males) for a randomized crossover trial of two 2-week-long dietary interventions. Participants were blinded to their assignment to one of the two sequence groups: either PPT-MED or MED-PPT diets. The PPT diet relies on a machine learning algorithm that integrates clinical and microbiome features to predict personal postprandial glucose responses (PPGR). We further evaluated the long-term effects of PPT diet on glycemic control and metabolic health by an additional 6-month PPT intervention (n = 16). Participants were connected to continuous glucose monitoring (CGM) throughout the study and self-recorded dietary intake using a smartphone application.ResultsIn the crossover intervention, the PPT diet lead to significant lower levels of CGM-based measures as compared to the MED diet, including average PPGR (mean difference between diets, - 19.8 ± 16.3 mg/dl × h, p < 0.001), mean glucose (mean difference between diets, - 7.8 ± 5.5 mg/dl, p < 0.001), and daily time of glucose levels > 140 mg/dl (mean difference between diets, - 2.42 ± 1.7 h/day, p < 0.001). Blood fructosamine also decreased significantly more during PPT compared to MED intervention (mean change difference between diets, - 16.4 ± 37 μmol/dl, p < 0.0001). At the end of 6 months, the PPT intervention leads to significant improvements in multiple metabolic health parameters, among them HbA1c (mean ± SD, - 0.39 ± 0.48%, p < 0.001), fasting glucose (- 16.4 ± 24.2 mg/dl, p = 0.02) and triglycerides (- 49 ± 46 mg/dl, p < 0.001). Importantly, 61% of the participants exhibited diabetes remission, as measured by HbA1c < 6.5%. Finally, some clinical improvements were significantly associated with gut microbiome changes per person.ConclusionIn this crossover trial in subjects with newly diagnosed T2DM, a PPT diet improved CGM-based glycemic measures significantly more than a Mediterranean-style MED diet. Additional 6-month PPT intervention further improved glycemic control and metabolic health parameters, supporting the clinical efficacy of this approach.Trial registrationClinicalTrials.gov number, NCT01892956.