The Association of Serum hsCRP and Urinary Alpha1-Microglobulin in Patients with Type 2 Diabetes Mellitus

Wan, Xiaohua; Zhang, Lin; Gu, Hui; Wang, Shenglai; Liu, Xiangyi

doi:10.1155/2019/6364390

Cited by 7 publications

(9 citation statements)

References 55 publications

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“…Of the laboratory parameters with less than the required 400 baseline values, it is of interest that brain natriuretic peptide, C-reactive protein and urinary alpha-1 microglobulin were greater than the ULN in more than 10% of the subjects as according to literature these three laboratory biomarkers have been shown to be elevated in individuals with diabetes. 12,13 This data, although with less than 400 subjects, may, therefore, be useful in better understanding the more currently esoteric laboratory parameters. The 28% of laboratory parameters being potentially different from the HVRR further support the pilot study and general medical judgement that it is not uncommon for laboratory parameter values to be different from the HVRR in patient populations.…”

Section: Discussionmentioning

confidence: 99%

<p>Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes</p>

Brott¹,

Goodman²,

Hermann³

et al. 2020

DDDT

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Background: Identification of laboratory parameter clinical safety signals depends on the terminology and scoring criteria. Grade 1 scoring criteria in the Common Terminology Criteria for Adverse Events (CTCAE) is typically based on the healthy volunteer reference range (HVRR). The objectives of this study were to determine 1) what laboratory parameters in individuals with diabetes are potentially different from the HVRR and 2) what fold change from baseline should be expected in this population. Materials and Methods: Baseline data from the individuals with diabetes clinical trial data (TransCelerate dataset) were compared to the HVRR using a 10% threshold above HVRR to classify laboratory parameters as potentially different from the HVRR. These parameters were then evaluated longitudinally to determine the expected x-baseline values for individuals with diabetes for potential use in identifying drug-induced changes. Results: The baseline data determined that 28% of the laboratory parameters evaluated were potentially different from the HVRR. Longitudinal data analysis determined 1) thresholds for 13 of these laboratory parameters with the subjects above the threshold having greater variability than those below the threshold, and 2) the expected upper limits (x-baseline) were calculated for the laboratory parameters. For example, a 1.8-2.6 x-baseline value for alanine aminotransferase, depending on how the baseline is calculated, is expected in individuals with diabetes. Conclusion: It is not uncommon for laboratory parameters in individuals with diabetes clinical trials to be potentially different from the HVRR, and the x-baseline criteria for 13 of these laboratory biomarkers was determined for this population. This suggests consideration in modifying the current CTCAE grade 1 criteria of >1.5-3.0 x-baseline should be further investigated as to if the current criteria detects too many false-positive signals in this population.

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Section: Discussionmentioning

confidence: 99%

<p>Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes</p>

Brott¹,

Goodman²,

Hermann³

et al. 2020

DDDT

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“…Moreover, UA1MG freely passes through the glomerular membranes, of which almost 99% is reabsorbed and catabolized by the proximal tubular cells [ 17 ]. Alpha1-microglobulinuria can be induced by glomerular dysfunction and reabsorption dysfunction of renal tubules [ 17 , 18 ]. In other words, UA1MG reflects not only glomerular function but also reflects tubular reabsorbing function.…”

Section: Discussionmentioning

confidence: 99%

“…Recent studies have indicated that UA1MG also participates in the inflammation process. As mentioned above, elevated UA1MG was related to higher plasma levels of CRP in patients with type 2 diabetes mellitus and myocardial infarction [ 14 , 18 ]. Although previous studies tended to describe A1MG as an antioxidant molecule, an increasing number of studies have questioned its protective role.…”

Section: Discussionmentioning

confidence: 99%

Urinary Alpha1-Microglobulin: A New Predictor for In-Hospital Mortality in Patients with ST-Segment Elevation Myocardial Infarction

et al. 2021

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“…A few studies have reported an inverse association between the hs-CRP level and GFR [ 29 , 30 ]. A recent study has also reported a link between hs-CRP elevation and urinary alpha-1 microglobulin (A1MG), an early sign of renal damage, in type II diabetes patients [ 31 ]. Our study provided evidence of the linkage of systemic inflammation and subclinical RI in seemingly healthy middle-aged and elderly community populations.…”

Section: Discussionmentioning

confidence: 99%

High-Sensitivity C-Reactive Protein Elevation Is Independently Associated with Subclinical Renal Impairment in the Middle-Aged and Elderly Population—A Community-Based Study in Northern Taiwan

Chuang

Lin

et al. 2020

IJERPH

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This cross-sectional study aimed to investigate the associations between high-sensitivity C-reactive protein (hs-CRP) and renal impairment (RI) among middle-aged and elderly people. We collected and analyzed demographic, anthropometric, metabolic, and renal function data in a community-based population in Northern Taiwan. We excluded subjects with acute inflammation from this study and defined RI as the presence of urinary albumin–creatinine ratio 30–300 mg/g or an estimated glomerular filtration rate of <60 mL/min/1.73 m2. There were 131, 125, and 125 participants in the low (≤0.80 mg/L), middle (0.81–1.76 mg/L), and high (>1.77 mg/L) hs-CRP tertiles, respectively. hs-CRP exhibited significantly positive correlations with body mass index, waist circumference, systolic blood pressure, triglyceride, and fasting plasma glucose, and a negative correlation with high-density lipoprotein. The prevalence and odds ratio of RI significantly increased across hs-CRP tertiles from low to high, and this trend remained significant after adjusting for the conventional cardiometabolic risk factors. hs-CRP ≥ 1.61 mg/L in the total group and ≥2.03 mg/L in the elderly group accurately predicted RI (p = 0.01 and 0.03, respectively). These findings suggest that we should carefully evaluate the renal function for at-risk individuals with hs-CRP elevation.

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The Association of Serum hsCRP and Urinary Alpha1-Microglobulin in Patients with Type 2 Diabetes Mellitus

Cited by 7 publications

References 55 publications

<p>Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes</p>

<p>Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes</p>

Urinary Alpha1-Microglobulin: A New Predictor for In-Hospital Mortality in Patients with ST-Segment Elevation Myocardial Infarction

High-Sensitivity C-Reactive Protein Elevation Is Independently Associated with Subclinical Renal Impairment in the Middle-Aged and Elderly Population—A Community-Based Study in Northern Taiwan

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