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  • 1
    Online Resource
    Online Resource
    Cluster Analysis of Cardiovascular Phenotypes in Patients With Type 2 Diabetes and Established Atherosclerotic Cardiovascular Disease: A Potential Approach to Precision Medicine
    American Diabetes Association ; 2022
    In:  Diabetes Care Vol. 45, No. 1 ( 2022-01-01), p. 204-212
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 45, No. 1 ( 2022-01-01), p. 204-212
    Abstract: Phenotypic heterogeneity among patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) is ill defined. We used cluster analysis machine-learning algorithms to identify phenotypes among trial participants with T2DM and ASCVD. RESEARCH DESIGN AND METHODS We used data from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study (n = 14,671), a cardiovascular outcome safety trial comparing sitagliptin with placebo in patients with T2DM and ASCVD (median follow-up 3.0 years). Cluster analysis using 40 baseline variables was conducted, with associations between clusters and the primary composite outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina) assessed by Cox proportional hazards models. We replicated the results using the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. RESULTS Four distinct phenotypes were identified: cluster I included Caucasian men with a high prevalence of coronary artery disease; cluster II included Asian patients with a low BMI; cluster III included women with noncoronary ASCVD disease; and cluster IV included patients with heart failure and kidney dysfunction. The primary outcome occurred, respectively, in 11.6%, 8.6%, 10.3%, and 16.8% of patients in clusters I to IV. The crude difference in cardiovascular risk for the highest versus lowest risk cluster (cluster IV vs. II) was statistically significant (hazard ratio 2.74 [95% CI 2.29–3.29]). Similar phenotypes and outcomes were identified in EXSCEL. CONCLUSIONS In patients with T2DM and ASCVD, cluster analysis identified four clinically distinct groups. Further cardiovascular phenotyping is warranted to inform patient care and optimize clinical trial designs.
    Type of Medium: Online Resource
    ISSN: 0149-5992
    URL: Article
    DOI: 10.2337/dc20-2806
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
    detail.hit.zdb_id: 1490520-6
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  • 2
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    Online Resource
    Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis
    American Diabetes Association ; 2022
    In:  Diabetes Care Vol. 45, No. 12 ( 2022-12-01), p. 2991-2998
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 45, No. 12 ( 2022-12-01), p. 2991-2998
    Abstract: Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium–glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ≥30 to ≤5,000 mg/g and estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 were randomly assigned to finerenone or placebo; SGLT2is were permitted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% eGFR decline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. RESULTS Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney composites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. CONCLUSIONS Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc22-0294
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
    detail.hit.zdb_id: 1490520-6
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  • 3
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    Online Resource
    1717-P: Burden of Type 2 Diabetes and Its Genetic Determinants in Indian Populations: Findings from the INDIGENIUS Consortium
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: To address the public health issue of type 2 diabetes (T2D) and its genetic profile in India, we aimed to evaluate genetic determinants of T2D using family-based cohorts from four distinct Endogamous Ethnic Groups (EEGs) representing two Northern (Punjab [Sikhs: SI] and Rajasthan [Agarwals: AG] ) and two Southern (Tamil Nadu [Chettiars: CH] and Andhra Pradesh [Reddys: RE] ) states of India, and to examine whether genetic variants found through targeted sequencing of the previously established 8 South Asian T2D risk loci (including the one from the Sikh population) are relevant to the AG, CH, and RE EEGs. In this study, we report the findings of T2D occurrence and genetic basis of T2D/related traits from the EEGs, as part of the INDIGENIUS (Indian Diabetes Genetic Studies in collaboration with U.S.) consortium studies, supported by an Indo-U.S. Collaborative Research Partnership on T2D. Data and samples were collected from three EEGs: AG (N=530, Families=25, mean age=43y, mean BMI=27, T2D=37%); CH (N=518, families=21, Age=47y, BMI=27, T2D=33%), and RE (N=500, Families=22, Age=46y, BMI=27, T2D=36%). Each of the families from an EEG was ascertained by a proband with T2D. The status of T2D was defined by ADA 2018 guidelines (fasting glucose≥126 mg/dl or HbA1c≥6.5% and/or use of diabetes medication/history). Similar characteristics for the SI EEG (N=1260, Families=324, Age=51y, BMI=27, T2D=75%) were obtained previously. We used the variance components method as implemented in the program SOLAR to carry out genetic analyses. All analyses were adjusted for age and sex effects. In all cohorts, T2D heritability (h2) (p & lt;0.05) ranged from 30% (CH) to 81% (AG). Other T2D-related traits (e.g., BMI, lipids, blood pressure, insulin, glucose) in AG, CH, and RE EEGs exhibited strong genetic influences (h2 range: 15% [triglycerides] - 90% [glucose; non-T2D] ). Our findings highlight high burden of T2D in Indian EEGs with significant additive genetic influences on T2D and its related traits. Disclosure V. Venkatesan: None. J.C. Lopez-Alvarenga: None. R. Arya: None. T. Koshy: None. U. Ravichandran: None. S. Sharma: None. S. Lodha: None. A.R. Ponnala: None. K.K. Sharma: None. M.V. Shaik: None. R.G. Resendez: None. D. Ramu: None. P. Venugopal: None. P. R.: None. N. S.: None. J.A. Ezeilo: None. C.A. Bejar: None. S. Mummidi: None. C. Natesan: None. J. Blangero: None. K.M. Medicherla: None. S. Thanikachalam: None. T. Sadras Panchatcharam: None. D. K.: None. R. Gupta: None. D.K. Sanghera: None. R. Duggirala: None. S.F. Paul: None. Funding Indian Council of Medical Research (55/6/2/Indo-US/2014-NCD-II); National Institute of Diabetes and Digestive and Kidney Diseases (R21DK105913)
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-1717-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1501252-9
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  • 4
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    Online Resource
    1639-P: Effect of Educational Status on Fasting Glucose and HbA1c Concentrations Independent of Income and Population Differences in Indian Populations
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: Higher education levels are known to be associated with better understanding and awareness of type 2 diabetes (T2D) and its complications. Given the diverse ethnic and socio-cultural characteristics of Indian populations, we aimed to study the effect of educational status on fasting glucose (FG) and HbA1c from three distinct Endogamous Ethnic Groups (EEGs) in India, which are part of the INDIGENIUS consortium, supported by an Indo-U.S. Collaborative Research Partnership on T2D. We obtained data from 1,548 individuals from 68 families (Mean age: 45.5(16)y, 51% men, BMI 26.7(5.2)), representing the communities of Chettiar (34%) from Tamil Nadu state, Agarwal (34%) from Rajasthan state, and Reddy (32%) from Andhra Pradesh state with different levels of income (Low, Middle, High) and education (Uneducated [UE], High School [HS] , Graduate [GD], and Postgraduate [PG] ). We rank-normalized FG and HbA1c by Van der Waerden's method and performed MANCOVA adjusting for covariates (age, sex, BMI, T2D and income). The main effects were EEG and education level. Data were standardized. Reddys exhibited the lowest value of FG [(-0.05 (SE: 0.06)] compared with Chettiars [0.48 (0.14)] and Agarwals [0.4 (0.04)] p & lt;0.001; for HbA1c, Reddys [0.18 (0.14)] were different from Agarwals [0.35 (0.04)] p & lt; 0.001, but not with Chettiars [0.18 (0.14)]. Once adjusted for confounders, education levels (UE, HS, GD, PG) showed association with FG as follows, respectively: 0.6 (0.1)a, 0.25 (0.06)b, 0.13 (0.06)c and 0.05 (0.08)c; and for HbA1c as follows: 0.37 (0.1)a, 0.23 (0.06)b, 0.1 (0.06)c and 0.1 (0.07)c. The letters a, b and c refer to homogenous groups p & lt;0.1. Education had significant effect on FG (and HbA1c) (p & lt; 0.003), but its interaction with sex was found only for FG (p & lt;0.036). In conclusion, fasting glucose and HbA1c concentrations are influenced by education level independent of income status and population background in the ethnically diverse Indian populations. Disclosure T. Koshy: None. R. Arya: None. J.C. Lopez-Alvarenga: None. V. Venkatesan: None. U. Ravichandran: None. S. Sharma: None. S. Lodha: None. A.R. Ponnala: None. K.K. Sharma: None. M.V. Shaik: None. R.G. Resendez: None. D. Ramu: None. P. Venugopal: None. P. R.: None. N. S.: None. J.A. Ezeilo: None. C.A. Bejar: None. S. Mummidi: None. C. Natesan: None. J. Blangero: None. K.M. Medicherla: None. S. Thanikachalam: None. T. Sadras Panchatcharam: None. D. K.: None. R. Gupta: None. R. Duggirala: None. D.K. Sanghera: None. S.F. Paul: None. Funding Indian Council of Medical Research (55/6/2/Indo-US/2014-NCD-II); National Institute of Diabetes and Digestive and Kidney Diseases (R21DK105913)
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-1639-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1501252-9
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