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Continuous glucose monitoring captures glycemic variability in obesity after sleeve gastrectomy: A prospective cohort study

Dorcely, Brenda; DeBermont, Julie; Gujral, Akash; Reid, Migdalia; Vanegas, Sally M.; Popp, Collin J.; Verano, Michael; Jay, Melanie; Schmidt, Ann Marie; Bergman, Michael; Goldberg, Ira J.; Alemán, José O.
Objective: HbA1c is an insensitive marker for assessing real-time dysglycemia in obesity. This study investigated whether 1-h plasma glucose level (1-h PG) ≥155 mg/dL (8.6 mmol/L) during an oral glucose tolerance test (OGTT) and continuous glucose monitoring (CGM) measurement of glucose variability (GV) better reflected dysglycemia than HbA1c after weight loss from metabolic and bariatric surgery. Methods: This was a prospective cohort study of 10 participants with type 2 diabetes compared with 11 participants with non-diabetes undergoing sleeve gastrectomy (SG). At each research visit; before SG, and 6 weeks and 6 months post-SG, body weight, fasting lipid levels, and PG and insulin concentrations during an OGTT were analyzed. Mean amplitude of glycemic excursions (MAGE), a CGM-derived GV index, was analyzed. Results: The 1-h PG correlated with insulin resistance markers, triglyceride/HDL ratio and triglyceride glucose index in both groups before surgery. At 6 months, SG caused 22% weight loss in both groups. Despite a reduction in HbA1c by 3.0 ± 1.3% in the diabetes group (p < 0.01), 1-h PG, and MAGE remained elevated, and the oral disposition index, which represents pancreatic β-cell function, remained reduced in the diabetes group when compared to the non-diabetes group. Conclusions: Elevation of GV markers and reduced disposition index following SG-induced weight loss in the diabetes group underscores persistent β-cell dysfunction and the potential residual risk of diabetes complications.
SCOPUS:85181687648
ISSN: 2055-2238
CID: 5629132

One-hour glucose is an earlier marker of dysglycemia than two-hour glucose

Ha, Joon; Chung, Stephanie T; Bogardus, Clifton; Jagannathan, Ram; Bergman, Michael; Sherman, Arthur S
AIMS/OBJECTIVE:The timing of increase in 1-hour PG and its utility as an earlier predictor of both prediabetes (PreDM) and type 2 diabetes (T2D) compared to 2-hour PG (2 h-PG) are unknown. To evaluate the timing of crossing of the 1 h-PG ≥ 155 mg/dl (8.6 mmol/L) for PreDM and 209 mg/dl (11.6 mmol/L) for T2D and respective current 2 h-PG thresholds of 140 mg/dl (7.8 mmol/L) and 200 mg/dl (11.1 mmol/L). METHODS:Secondary analysis of 201 Southwest Native Americans who were followed longitudinally for 6-10 years and had at least 3 OGTTs. RESULTS:We identified a subset of 43 individuals who first developed PreDM by both 1 h-PG and 2 h-PG criteria during the study. For most (32/43,74%), 1 h-PG ≥ 155 mg/dl was observed before 2 h-PG reached 140 mg/dl (median [IQR]: 1.7 [-0.25, 4.59] y; mean ± SEM: 5.3 ± 1.9 y). We also identified a subset of 33 individuals who first developed T2D during the study. For most (25/33, 75%), 1 h-PG reached 209 mg/dl earlier (median 1.0 [-0.56, 2.02] y; mean ± SEM: 1.6 ± 0.8 y) than 2 h-PG reached 200 mg/dl, diagnostic of T2D. CONCLUSIONS:1 h-PG ≥ 155 mg/dl is an earlier marker of elevated risk for PreDM and T2D than 2 h-PG ≥ 140 mg/dl.
PMCID:10592221
PMID: 37482221
ISSN: 1872-8227
CID: 5618792

A randomized clinical trial comparing low-fat with precision nutrition-based diets for weight loss: impact on glycemic variability and HbA1c

Kharmats, Anna Y; Popp, Collin; Hu, Lu; Berube, Lauren; Curran, Margaret; Wang, Chan; Pompeii, Mary Lou; Li, Huilin; Bergman, Michael; St-Jules, David E; Segal, Eran; Schoenthaler, Antoinette; Williams, Natasha; Schmidt, Ann Marie; Barua, Souptik; Sevick, Mary Ann
BACKGROUND:Recent studies have demonstrated considerable interindividual variability in postprandial glucose response (PPGR) to the same foods, suggesting the need for more precise methods for predicting and controlling PPGR. In the Personal Nutrition Project, the investigators tested a precision nutrition algorithm for predicting an individual's PPGR. OBJECTIVE:This study aimed to compare changes in glycemic variability (GV) and HbA1c in 2 calorie-restricted weight loss diets in adults with prediabetes or moderately controlled type 2 diabetes (T2D), which were tertiary outcomes of the Personal Diet Study. METHODS:The Personal Diet Study was a randomized clinical trial to compare a 1-size-fits-all low-fat diet (hereafter, standardized) with a personalized diet (hereafter, personalized). Both groups received behavioral weight loss counseling and were instructed to self-monitor diets using a smartphone application. The personalized arm received personalized feedback through the application to reduce their PPGR. Continuous glucose monitoring (CGM) data were collected at baseline, 3 mo and 6 mo. Changes in mean amplitude of glycemic excursions (MAGEs) and HbA1c at 6 mo were assessed. We performed an intention-to-treat analysis using linear mixed regressions. RESULTS:We included 156 participants [66.5% women, 55.7% White, 24.1% Black, mean age 59.1 y (standard deviation (SD) = 10.7 y)] in these analyses (standardized = 75, personalized = 81). MAGE decreased by 0.83 mg/dL per month for standardized (95% CI: 0.21, 1.46 mg/dL; P = 0.009) and 0.79 mg/dL per month for personalized (95% CI: 0.19, 1.39 mg/dL; P = 0.010) diet, with no between-group differences (P = 0.92). Trends were similar for HbA1c values. CONCLUSIONS:Personalized diet did not result in an increased reduction in GV or HbA1c in patients with prediabetes and moderately controlled T2D, compared with a standardized diet. Additional subgroup analyses may help to identify patients who are more likely to benefit from this personalized intervention. This trial was registered at clinicaltrials.gov as NCT03336411.
PMID: 37236549
ISSN: 1938-3207
CID: 5508702

Response to the Letter to the Editor: "Two Decade of Diabetes Prevention Efforts: A Call to Innovate and Revitalize Our Approach to Lifestyle Change" [Letter]

Golovaty, Ilya; Bergman, Michael; Moin, Tannaz
PMID: 37105399
ISSN: 1872-8227
CID: 5465402

Current diagnostic criteria identify risk for type 2 diabetes too late

Bergman, Michael; Buysschaert, Martin; Ceriello, Antonio; Hussain, Akhtar; Mohan, Viswanathan; Sesti, Giorgio; Tuomilehto, Jaakko
PMID: 36803366
ISSN: 2213-8595
CID: 5448092

Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices

Gupta, Avni; Hu, Jiyuan; Huang, Shengnan; Diaz, Laura; Gore, Radhika; Levy, Natalie; Bergman, Michael; Tanner, Michael; Sherman, Scott E; Islam, Nadia; Schwartz, Mark D
BACKGROUND:It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). METHODS:We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. RESULTS:Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). CONCLUSIONS:The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. TRIAL REGISTRATION:The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666 .
PMCID:10045092
PMID: 36978071
ISSN: 1471-2458
CID: 5454102

A simulation model estimates lifetime health and economic outcomes of screening prediabetes using the 1-h plasma glucose

Andellini, Martina; Manco, Melania; Esposito, Maria Teresa; Tozzi, Alberto Eugenio; Bergman, Michael; Ritrovato, Matteo
AIMS/OBJECTIVE:The current method to diagnose impaired glucose tolerance (IGT) is based on the 2-h plasma glucose (2-hPG) value during a 75-g oral glucose tolerance test (OGTT). Robust evidence demonstrates that the 1-h post-load plasma glucose (1-hPG) ≥ 8.6 mmol/L in those with normal glucose tolerance is highly predictive of type 2 diabetes (T2D), micro and macrovascular complications and mortality. The aim of this study was to conduct a health economic analysis to estimate long-term cost-effectiveness of using the 1-hPG compared to the 2-hPG for screening and assessing the risk of diabetes over 35 years. The main outcome was cost per quality-adjusted life year (QALY) gained. METHODS:A Monte Carlo-based Markov simulation model was developed to forecast long-term effects of two screening strategies with regards to clinical and cost-effectiveness outcomes. The base case model included 20,000 simulated patients over 35-years follow-up. Transition probabilities on disease progression, mortality, effects on preventive treatments and complications were retrieved from landmark diabetes studies. Direct medical costs were sourced from published literature and inflated to 2019 Euros. RESULTS:In the lifetime analysis, the 1-hPG was projected to increase the number of years free from disease (2 years per patient); to delay the onset of T2D (1 year per patient); to reduce the incidence of T2D complications (0·6 RR-Relative Risk per patient) and to increase the QALY gained (0·58 per patient). Even if the 1-hPG diagnostic method resulted in higher initial costs associated with preventive treatment, long-term diabetes-related costs as well as complications costs were reduced leading to a lifetime saving of - 31225719.82€. The incremental cost-effectiveness ratio was - 8214.7€ per each QALY gained for the overall population. CONCLUSIONS:Screening prediabetes with the 1-hPG is feasible and cost-effective resulting in reduced costs per QALY. Notwithstanding, the higher initial costs of testing with the 1-hPG compared to the 2-hPG due to incremental preventive intervention, long-term diabetes and complications costs were reduced projecting an overall cost saving of - 8214.7€ per each QALY gained.
PMID: 36127565
ISSN: 1432-5233
CID: 5335372

Editorial: Prediabetes: new insights on the diagnosis, risk stratification, comorbidites, cardiovascular disease, microvascular complications, and treatment [Editorial]

Neves, João Sérgio; Buysschaert, Martin; Bergman, Michael
PMID: 37251678
ISSN: 1664-2392
CID: 5541562

Two Decades of Diabetes Prevention Efforts: A Call to Innovate and Revitalize Our Approach to Lifestyle Change

Golovaty, Ilya; Ritchie, Natalie D; Tuomilehto, Jaakko; Mohan, Viswanathan; Ali, Mohammed K; Gregg, Edward W; Bergman, Michael; Moin, Tannaz
The impact of global diabetes prevention efforts has been modest despite the promise of landmark diabetes prevention trials nearly twenty years ago. While national and regional initiatives show potential, challenges remain to adapt large-scale strategies in the real-world that fits individuals and their communities. Additionally, the sedentary lifestyle changes during the COVID-19 pandemic and guidelines that now call for earlier screening (e.g., US Preventative Task Force) will increase the pool of eligible adults worldwide. Thus, a more adaptable, person-centered approach that expands the current toolkit is urgently needed to innovate and revitalize our approach to diabetes prevention. This review identifies key priorities to optimize the population-level delivery of diabetes prevention based on a consensus-based evaluation of the current evidence among experts in global translational programs; key priorities identified include (1) participant eligibility, (2) intervention intensity, (3) delivery components, (4) behavioral economics, (5) technology, and (6) the role of pharmacotherapy. We offer a conceptual framework for a broader, person-centered approach to better address an individual's risk, readiness, barriers, and digital competency.
PMID: 36470316
ISSN: 1872-8227
CID: 5378632

Bone mineral density, osteopenia and osteoporosis among US adults with cancer

Huang, J-F; Tan, Q-C; Bai, H; Wang, J; Bergman, M; Wu, Z
BACKGROUND:Bone mineral deficits are one of the most common complications in cancer survivors. However, there are no studies evaluating bone mineral density (BMD) and the prevalence of osteopenia and osteoporosis among patients with different types of cancers. AIM/OBJECTIVE:The objective was to assess BMD and evaluate the prevalence of osteopenia and osteoporosis among US adults with cancer. DESIGN/METHODS:A cross-section propensity score matching study. METHODS:We extracted data from National Health and Nutrition Examination Survey database from 2005 to 2018. We compared BMD in participants with and without cancer which was further analyzed according to cancer type. We conducted logistic regression to evaluate adjusted odds ratios of osteopenia and osteoporosis and determine risk factors for their development. RESULTS:We found that BMD was significantly higher in participants without cancer than cancer patients. Furthermore, the median BMD of patients with breast cancer or skin cancer (including melanoma) was significantly lower than participants without cancer. People with breast, lung, genitourinary and skin cancers were more likely to incur osteopenia/osteoporosis than those without cancer. CONCLUSIONS:BMD differs depending upon type in survivors. Individuals with a history of cancer have a poor understanding of osteoporosis and its risk factors. Understanding risk factors in patients with cancers identified in our study may be helpful for preventing osteoporosis and fractures and the development of screening guidelines.
PMID: 35092293
ISSN: 1460-2393
CID: 5155012