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  • 1
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    Gestational Diabetes Mellitus and Diet: A Systematic Review and Meta-analysis of Randomized Controlled Trials Examining the Impact of Modified Dietary Interventions on Maternal Glucose Control and Neonatal Birth Weight
    American Diabetes Association ; 2018
    In:  Diabetes Care Vol. 41, No. 7 ( 2018-07-01), p. 1346-1361
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 41, No. 7 ( 2018-07-01), p. 1346-1361
    Abstract: Medical nutrition therapy is a mainstay of gestational diabetes mellitus (GDM) treatment. However, data are limited regarding the optimal diet for achieving euglycemia and improved perinatal outcomes. This study aims to investigate whether modified dietary interventions are associated with improved glycemia and/or improved birth weight outcomes in women with GDM when compared with control dietary interventions. RESEARCH DESIGN AND METHODS Data from published randomized controlled trials that reported on dietary components, maternal glycemia, and birth weight were gathered from 12 databases. Data were extracted in duplicate using prespecified forms. RESULTS From 2,269 records screened, 18 randomized controlled trials involving 1,151 women were included. Pooled analysis demonstrated that for modified dietary interventions when compared with control subjects, there was a larger decrease in fasting and postprandial glucose (−4.07 mg/dL [95% CI −7.58, −0.57]; P = 0.02 and −7.78 mg/dL [95% CI −12.27, −3.29] ; P = 0.0007, respectively) and a lower need for medication treatment (relative risk 0.65 [95% CI 0.47, 0.88]; P = 0.006). For neonatal outcomes, analysis of 16 randomized controlled trials including 841 participants showed that modified dietary interventions were associated with lower infant birth weight (−170.62 g [95% CI −333.64, −7.60] ; P = 0.04) and less macrosomia (relative risk 0.49 [95% CI 0.27, 0.88]; P = 0.02). The quality of evidence for these outcomes was low to very low. Baseline differences between groups in postprandial glucose may have influenced glucose-related outcomes. As well, relatively small numbers of study participants limit between-diet comparison. CONCLUSIONS Modified dietary interventions favorably influenced outcomes related to maternal glycemia and birth weight. This indicates that there is room for improvement in usual dietary advice for women with GDM.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc18-0102
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 2
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    1407-P: Laboratory Glycemic Markers vs. Continuous Glucose Monitoring (CGM) for Prediction of Neonatal Outcomes in Type 1 Diabetes Pregnancy—An Ancillary Study of the CONCEPTT Trial
    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: Type 1 diabetes (T1D) in pregnancy is associated with increased neonatal morbidity, which improves with optimal glycemic control. Aim: To compare lab and CGM glucose summary measures as predictors of neonatal outcomes in T1D pregnancy. Methods: 225 CONCEPTT participants had 6-day CGM and blood analysis of glycemic markers in 1st trimester, 24 and 34 weeks (Average glucose; % time in target 63-140 mg/dl, coefficient of variation (CV)); HbA1c; glycated CD59 (gCD59); 1,5-anhydroglucitol (1,5AG); glycated albumin). Outcomes: large for gestational age (LGA), neonatal hypoglycemia (NH) and neonatal intensive care unit (NICU) admission. Statistics: Unadjusted logistic regression. Results: All glucose summary measures excluding CV predicted neonatal outcomes (Table). Glycemic control at all timepoints from 1st trimester was important for LGA, but emerged later for NH (24 and 34 weeks) and NICU (mainly 24 weeks). Both CGM time in target and average glucose and lab markers HbA1c, 1,5AG and gCD59 predicted all three outcomes studied. Time in target was the best CGM predictor. The best lab predictors were HbA1c, 1,5AG and gCD59. HbA1c was the strongest predictor of LGA and NH, but only predicted NICU admission late in pregnancy. Conclusions: In women with T1D, both CGM and lab glucose summary measures can predict neonatal outcomes from 1st trimester. Disclosure C.L. Meek: None. D. Tundidor: None. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. J.M. Yamamoto: None. E.M. Scott: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott, Eli Lilly and Company. D. Ma: None. J. Halperin: Stock/Shareholder; Self; Mellitus, LLC. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. R. Corcoy: None. Funding JDRF; Canadian Clinical Trials Network; National Institute for Health Research; European Foundation for the Study of Diabetes/Sanofi; Diabetes UK (17/0005712 to C.L.M.); Asahi Kasei Pharma Corporation; GlycoMark, Inc.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-1407-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 3
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    Novel Biochemical Markers of Glycemia to Predict Pregnancy Outcomes in Women With Type 1 Diabetes
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 3 ( 2021-03-01), p. 681-689
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 3 ( 2021-03-01), p. 681-689
    Abstract: The optimal method of monitoring glycemia in pregnant women with type 1 diabetes remains controversial. This study aimed to assess the predictive performance of HbA1c, continuous glucose monitoring (CGM) metrics, and alternative biochemical markers of glycemia to predict obstetric and neonatal outcomes. RESEARCH DESIGN AND METHODS One hundred fifty-seven women from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) were included in this prespecified secondary analysis. HbA1c, CGM data, and alternative biochemical markers (glycated CD59, 1,5-anhydroglucitol, fructosamine, glycated albumin) were compared at ∼12, 24, and 34 weeks’ gestation using logistic regression and receiver operating characteristic (ROC) curves to predict pregnancy complications (preeclampsia, preterm delivery, large for gestational age, neonatal hypoglycemia, admission to neonatal intensive care unit). RESULTS HbA1c, CGM metrics, and alternative laboratory markers were all significantly associated with obstetric and neonatal outcomes at 24 weeks’ gestation. More outcomes were associated with CGM metrics during the first trimester and with laboratory markers (area under the ROC curve generally & lt;0.7) during the third trimester. Time in range (TIR) (63–140 mg/dL [3.5–7.8 mmol/L]) and time above range (TAR) ( & gt;140 mg/dL [ & gt;7.8 mmol/L]) were the most consistently predictive CGM metrics. HbA1c was also a consistent predictor of suboptimal pregnancy outcomes. Some alternative laboratory markers showed promise, but overall, they had lower predictive ability than HbA1c. CONCLUSIONS HbA1c is still an important biomarker for obstetric and neonatal outcomes in type 1 diabetes pregnancy. Alternative biochemical markers of glycemia and other CGM metrics did not substantially increase the prediction of pregnancy outcomes compared with widely available HbA1c and increasingly available CGM metrics (TIR and TAR).
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-2360
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 4
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    Adaptability of Closed-Loop during Labor, Delivery, and Postpartum—A Secondary Analysis of Data From Two Randomized Crossover Trials in Type 1 Diabetes Pregnancy
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: Our aim was to evaluate the efficacy of closed-loop insulin delivery for maintaining glucose control in women with type 1 diabetes during labor, delivery and the immediate postpartum period. We report on data collected from two randomized crossover trials examining closed-loop in pregnancy. This is an observational study of women who chose to continue closed-loop during labor, delivery and 48-hour postpartum period. Of the 32 women in these trials, 27 (84.4%) continued closed-loop during this time. Women who used closed-loop during labor and delivery spent 82.0% (IQR 49.3, 93.0) of time in the target range, with a mean glucose level of 124.2±25.4 mg/dl. Closed-loop performed well throughout all modes of delivery (Table 1). In the 48-hour postpartum period, the mean glucose was 130±25.0 mg/dl. During this time women spent 83.3% (IQR 75.2, 94.6) time-in-target range. There was no difference in mean glucose in mothers of infants with neonatal hypoglycemia vs. those without (mean maternal glucose of 124.2±28.8 and 122.4±19.8 mg/dL respectively; p=0.84). This study demonstrates that closed-loop insulin delivery is safe and effective in labor, delivery and the immediate postpartum period. Future research is needed to compare the biomedical efficacy of closed-loop with intensive insulin therapy and intrapartum sliding scale approaches.Table 1: Glucose control during labor and delivery by mode of deliveryVaginal Delivery n=4Emergency Caesarean Section n=12Elective Caesarian Section n=11Mean glucose (mg/dl)113.1±2.7126.1±27.0126.2±28.7Median time-in-target in %84.3 (74.7, 88.8)84.4 (48.5, 93.7)76.5 (48.2, 93.0Median time below target in %0 (0, 3.4)0.8 (0, 2.0)0 (0, 2.2)Median time above target in %15.7 (11.2, 22.0)11.4 (6.3, 50.4)16.5 (7.1, 51.8)Median number of hypoglycemic events0 (0, 1.0)0 (0, 1.0)0 (0, 1.0)Number of women with a hypoglycemic event133 Disclosure J.M. Yamamoto: None. Z.A. Stewart: None. M.E. Wilinska: None. S. Hartnell: Speaker's Bureau; Self; Medtronic, Roche Pharma. R. Hovorka: Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Eli Lilly and Company, AstraZeneca. Other Relationship; Self; B. Braun Medical Inc.. Research Support; Self; Medtronic. Other Relationship; Self; Medtronic. Research Support; Self; Abbott, JDRF, Diabetes UK, National Institute of Diabetes and Digestive and Kidney Diseases. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc.. Research Support; Self; Abbott.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1432-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 5
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    Dietary Patterns of Insulin Pump and Multiple Daily Injection Users During Type 1 Diabetes Pregnancy
    American Diabetes Association ; 2020
    In:  Diabetes Care Vol. 43, No. 1 ( 2020-01-01), p. e5-e7
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 1 ( 2020-01-01), p. e5-e7
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-1908
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 6
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    277-OR: Use of Noncarbohydrate Fuels Is Associated with Materno-Fetal Complications in Type 1 Diabetes Pregnancy: Metabolomics Analysis of the CONCEPTT Trial
    American Diabetes Association ; 2021
    In:  Diabetes Vol. 70, No. Supplement_1 ( 2021-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 70, No. Supplement_1 ( 2021-06-01)
    Abstract: Aims: We assessed metabolomic signatures in maternal and cord blood associated with suboptimal outcomes in the continuous glucose monitoring in women with type 1 diabetes in pregnancy trial (CONCEPTT). Methods: Serum samples from 162 mothers (12, 24 and 34 weeks’ gestation) and 93 cord blood samples were analysed for 1049 metabolites and 1041 lipids using ultra-performance liquid chromatography-tandem mass spectroscopy. We used adjusted and unadjusted logistic regression of metabolomic variables using adjudicated outcomes: extremely-large-for-gestational-age (ELGA; & gt;97.5th centile), pre-eclampsia and neonatal hypoglycaemia with modified Bonferroni false discovery rate p≤0.001. Results: All materno-fetal complications studied were associated with reliance on non-carbohydrate sources of fuel. Lipids through beta oxidation were the main fuel source in ELGA (24 and 34 weeks), neonatal hypoglycaemia (12 weeks only) and pre-eclampsia (12 and 24 weeks). Marked protein catabolism was evident in neonatal hypoglycaemia (34 weeks) and pre-eclampsia (24 and 34 weeks). Cord blood in ELGA infants showed evidence of simultaneous beta oxidation and de novo lipogenesis, a biologically futile cycle of creating and destroying lipids, which consumes excess energy and substrate. Cord blood from infants with neonatal hypoglycaemia showed evidence of pronounced protein catabolism providing glucogenic amino acids for gluconeogenesis. Conclusions: Reliance on lipid or protein sources for fuel was associated with ELGA, neonatal hypoglycaemia and pre-eclampsia. Carbohydrate metabolism was insufficient to meet cellular energy demands, possibly due to insufficient insulin, insufficient dietary carbohydrate or both. Improving outcomes in type 1 diabetes pregnancy may require greater focus on normalising carbohydrate metabolism through optimal carbohydrate intake and matched insulin dosing. Disclosure C. L. Meek: None. Z. Stewart: None. S. Furse: None. J. M. Yamamoto: None. D. Feig: Advisory Panel; Self; Novo Nordisk. A. Koulman: None. H. R. Murphy: None. Funding JDRF (17/2011/533, 80/2010/585); Diabetes UK (DUK-HKF 17/0005712, DUK-PG 17/0005633.BBSRC BB/M027252/1)
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db21-277-OR
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 7
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    282-OR: Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Background: Postpartum demands of caring for a newborn, breastfeeding, and sleep deprivation result in little time for self care of type 1 diabetes (T1D). Data are limited on the efficacy, safety and feasibility of closed loop insulin delivery postpartum. Methods: We performed an open label, controlled pilot trial randomizing women to hybrid closed loop insulin delivery Medtronic MiniMed™ 670G/770G in auto mode or sensor augmented insulin pump (SAP) therapy in the first 12 twelve postpartum weeks. The primary outcome was the percent time in target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Mixed models analysis assessed between group differences in glucose measures from median start time of closed loop (8 days) to 12wks postpartum. Results: Twenty women were recruited. Two withdrew prior to randomization. The remaining 18 women completed 12 weeks of postpartum follow up in their assigned randomization group. Overall baseline mean age, duration of T1D and first pregnancy A1c was 32 years, 22 years and 6.9% respectively. Analyses adjusted for first pregnancy A1c and was intention to treat. Time in range did not differ between groups (79 ± 8.0% versus 80 ± 6.4% p =.079). Time below 70mg/dL (3.9 mmol/L) and 54mg/dL (3.0 mmol/L) was less for women randomized to closed loop versus SAP (1.6 ± .72 % vs 5.3 ± 3.3 % p & lt;0.001 and .23 ± .16 % vs .95 ± .82 % p = 0.002 respectively). Time above 180 mg/dL (10 mmol/L) was not different between groups 19.5 ±8.7% vs 15.9 ±7.8% p = .823. Mean glucose was 146 ± 13 and 133 ± 14 mg/dL p & lt;.001 for closed loop and SAP groups respectively. No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group. Conclusions: Closed loop insulin delivery postpartum was associated with less hypoglycemia than SAP and slightly higher mean glucose. There were no safety concerns. Time in target glucose range was high, minimizing the potential for further improvement with closed loop. These findings are reassuring for the use of closed loop insulin delivery postpartum because of its’ potential to reduce hypoglycemia. Disclosure L.E.Donovan: Research Support; Dexcom, Inc., Medtronic, Tandem Diabetes Care, Inc., Inner Analytics. D.Feig: Advisory Panel; Novo Nordisk Canada Inc., Speaker's Bureau; Sanofi, Novo Nordisk Canada Inc. P.Lemieux: Other Relationship; Dexcom, Inc. H.R.Murphy: Advisory Panel; Medtronic, Research Support; Dexcom, Inc. R.C.Bell: None. R.J.Sigal: Research Support; Novo Nordisk. J.Ho: None. J.M.Yamamoto: None. Funding Calgary Health Trust
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-282-OR
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 8
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    1385-P: Associations between Maternal Metabolomic and Lipidomic Profiles across Gestation with Neonatal Birthweight in Type 1 Diabetes Pregnancy
    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: Aims/Objectives: To describe the maternal-fetal metabolomic and lipidomic profiles and examine associations with neonatal birthweight in type 1 diabetes pregnancy. Methods: A longitudinal prospective study of 162 CONCEPTT mothers. 1049 maternal metabolites and 1041 lipids were analyzed at 12, 24 and 34 weeks gestation, in addition to 93 cord-blood samples using ultra-performance liquid chromatography-tandem mass spectroscopy. The effects on neonatal birth weight, classified as appropriate for gestational age (AGA) 10-90th percentile, large for gestational age (LGA) & gt;90th percentile and extreme LGA (ELGA) & gt;97.7th percentile were examined through ANOVA, principle component analysis and hierarchical clustering, adjusting for maternal BMI. Results: Significant gestational changes in the maternal metabolome and lipidomic profiles were observed. Metabolite changes associated with birthweight were modest in LGA, albeit more apparent in ELGA. At 24 and 34 weeks, glucose levels were significantly elevated and 1,5-anhydroglucitol (1,5-AG) significantly reduced in ELGA mothers. Triglycerides did not differ between AGA and LGA. Throughout pregnancy, many lipid classes were lower in LGA mothers, with modest increases in free fatty acids and acylcarnitine species at 34 weeks in ELGA. The distribution of lipid classes was significantly different between maternal and cord-blood samples, with most cord-blood lipids comparable between AGA, LGA and ELGA. There were some differences in the cord-blood steroid hormones and acylcarnitine species of ELGA neonates. Conclusions: Gestational changes in maternal-fetal metabolomic and lipidomic profiles are largely conserved across birthweight categories. Some differences in glucose handling, lipid homeostasis, steroid hormones and acylcarnitine species were apparent in maternal-fetal samples of ELGA neonates. Disclosure Z.A. Stewart: None. J.M. Yamamoto: None. C.L. Meek: None. J. Sanchez: None. D. Feig: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. H.R. Murphy: Advisory Panel; Self; Medtronic MiniMed, Inc. Funding Diabetes UK; JDRF
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-1385-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 9
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    Identification of Genetic Variation Influencing Metformin Response in a Multiancestry Genome-Wide Association Study in the Diabetes Prevention Program (DPP)
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. 8 ( 2023-08-01), p. 1161-1172
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. 8 ( 2023-08-01), p. 1161-1172
    Abstract: Genome-wide significant loci for metformin response in type 2 diabetes reported elsewhere have not been replicated in the Diabetes Prevention Program (DPP). To assess pharmacogenetic interactions in prediabetes, we conducted a genome-wide association study (GWAS) in the DPP. Cox proportional hazards models tested associations with diabetes incidence in the metformin (MET; n = 876) and placebo (PBO; n = 887) arms. Multiple linear regression assessed association with 1-year change in metformin-related quantitative traits, adjusted for baseline trait, age, sex, and 10 ancestry principal components. We tested for gene-by-treatment interaction. No significant associations emerged for diabetes incidence. We identified four genome-wide significant variants after correcting for correlated traits (P & lt; 9 × 10−9). In the MET arm, rs144322333 near ENOSF1 (minor allele frequency [MAF]AFR = 0.07; MAFEUR = 0.002) was associated with an increase in percentage of glycated hemoglobin (per minor allele, β = 0.39 [95% CI 0.28, 0.50] ; P = 2.8 × 10−12). rs145591055 near OMSR (MAF = 0.10 in American Indians) was associated with weight loss (kilograms) (per G allele, β = −7.55 [95% CI −9.88, −5.22]; P = 3.2 × 10−10) in the MET arm. Neither variant was significant in PBO; gene-by-treatment interaction was significant for both variants [P(G×T) & lt; 1.0 × 10−4]. Replication in individuals with diabetes did not yield significant findings. A GWAS for metformin response in prediabetes revealed novel ethnic-specific associations that require further investigation but may have implications for tailored therapy.
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db22-0702
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 10
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    Risk Factors for the Development of Retinopathy in Prediabetes and Type 2 Diabetes: The Diabetes Prevention Program Experience
    American Diabetes Association ; 2022
    In:  Diabetes Care Vol. 45, No. 11 ( 2022-11-01), p. 2653-2661
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 45, No. 11 ( 2022-11-01), p. 2653-2661
    Abstract: To determine glycemic and nonglycemic risk factors that contribute to the presence of diabetic retinopathy (DR) before and after the onset of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS During the Diabetes Prevention Program (DPP) and DPP Outcome Study (DPPOS), we performed fundus photography over time in adults at high risk for developing T2D, including after they developed diabetes. Fundus photographs were graded using the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system, with DR defined as typical lesions of DR (microaneurysms, exudates, hemorrhage, or worse) in either eye. RESULTS By DPPOS year 16 (∼20 years after random assignment into DPP), 24% of 1,614 participants who had developed T2D and 14% of 885 who remained without diabetes had DR. In univariate analyses, using results from across the entire duration of follow-up, American Indian race was associated with less frequent DR compared with non-Hispanic White (NHW) race, and higher HbA1c, fasting and 2-h plasma glucose levels during an oral glucose tolerance test, weight, and history of hypertension, dyslipidemia, and smoking, but not treatment group assignment, were associated with more frequent DR. On multivariate analysis, American Indian race was associated with less DR compared with NHW (odds ratio [OR] 0.36, 95% CI 0.20–0.66), and average HbA1c was associated with more DR (OR 1.92, 95% CI 1.46–1.74 per SD [0.7%] increase in HbA1c). CONCLUSIONS DR may occur in adults with prediabetes and early in the course of T2D. HbA1c was an important risk factor for the development of DR across the entire glycemic range from prediabetes to T2D.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc22-0860
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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