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  1. Article ; Online: Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19. Reply.

    Bramante, Carolyn T / Buse, John B / Boulware, David R

    The New England journal of medicine

    2022  Volume 387, Issue 24, Page(s) e65

    MeSH term(s) Humans ; Ivermectin/therapeutic use ; Fluvoxamine ; Metformin/therapeutic use ; COVID-19
    Chemical Substances Ivermectin (70288-86-7) ; Fluvoxamine (O4L1XPO44W) ; Metformin (9100L32L2N)
    Language English
    Publishing date 2022-12-14
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2212542
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Fish Consumption During Pregnancy-Reply.

    Spiller, Philip / Bramante, Carolyn T / Landa, Michael

    JAMA pediatrics

    2019  Volume 173, Issue 3, Page(s) 292–293

    MeSH term(s) Animals ; Female ; Fishes ; Humans ; Pregnancy ; Seafood
    Language English
    Publishing date 2019-01-11
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2701223-2
    ISSN 2168-6211 ; 2168-6203
    ISSN (online) 2168-6211
    ISSN 2168-6203
    DOI 10.1001/jamapediatrics.2018.4923
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Does COVID-19 Infection Increase the Risk of Diabetes? Current Evidence.

    Wong, Rachel / Lam, Emily / Bramante, Carolyn T / Johnson, Steven G / Reusch, Jane / Wilkins, Kenneth J / Yeh, Hsin-Chieh

    Current diabetes reports

    2023  Volume 23, Issue 8, Page(s) 207–216

    Abstract: Purpose of review: Multiple studies report an increased incidence of diabetes following SARS-CoV-2 infection. Given the potential increased global burden of diabetes, understanding the effect of SARS-CoV-2 in the epidemiology of diabetes is important. ... ...

    Abstract Purpose of review: Multiple studies report an increased incidence of diabetes following SARS-CoV-2 infection. Given the potential increased global burden of diabetes, understanding the effect of SARS-CoV-2 in the epidemiology of diabetes is important. Our aim was to review the evidence pertaining to the risk of incident diabetes after COVID-19 infection.
    Recent findings: Incident diabetes risk increased by approximately 60% compared to patients without SARS-CoV-2 infection. Risk also increased compared to non-COVID-19 respiratory infections, suggesting SARS-CoV-2-mediated mechanisms rather than general morbidity after respiratory illness. Evidence is mixed regarding the association between SARS-CoV-2 infection and T1D. SARS-CoV-2 infection is associated with an elevated risk of T2D, but it is unclear whether the incident diabetes is persistent over time or differs in severity over time. SARS-CoV-2 infection is associated with an increased risk of incident diabetes. Future studies should evaluate vaccination, viral variant, and patient- and treatment-related factors that influence risk.
    MeSH term(s) Humans ; COVID-19 ; SARS-CoV-2 ; Diabetes Mellitus/epidemiology ; Incidence
    Language English
    Publishing date 2023-06-07
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2065167-3
    ISSN 1539-0829 ; 1534-4827
    ISSN (online) 1539-0829
    ISSN 1534-4827
    DOI 10.1007/s11892-023-01515-1
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  4. Article ; Online: Metformin for Treatment of Acute COVID-19: Systematic Review of Clinical Trial Data Against SARS-CoV-2.

    Erickson, Spencer M / Fenno, Sarah L / Barzilai, Nir / Kuchel, George / Bartley, Jenna M / Justice, Jamie Nicole / Buse, John B / Bramante, Carolyn T

    Diabetes care

    2023  Volume 46, Issue 7, Page(s) 1432–1442

    Abstract: Background: Observational and preclinical data suggest metformin may prevent severe coronavirus disease 2019 (COVID-19) outcomes.: Purpose: We conducted a systematic review of randomized, placebo-controlled clinical trials of metformin treatment for ... ...

    Abstract Background: Observational and preclinical data suggest metformin may prevent severe coronavirus disease 2019 (COVID-19) outcomes.
    Purpose: We conducted a systematic review of randomized, placebo-controlled clinical trials of metformin treatment for COVID-19 to determine whether metformin affects clinical or laboratory outcomes in individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and present a structured summary of preclinical data.
    Study selection: Two independent reviewers searched PubMed, Scopus, Cochrane COVID-19 Study Register, and ClinicalTrials.gov on 1 February 2023 with no date restrictions for trials where investigators randomized adults with COVID-19 to metformin versus control and assessed clinical and/or laboratory outcomes of interest. The Cochrane Risk of Bias 2 tool was used to assess bias.
    Data extraction: Two reviewers extracted data pertaining to prespecified outcomes of each interest from each included trial.
    Data synthesis: The synthesis plan was developed a priori and was guided by Synthesis Without Meta-analysis (SWiM) guidelines. Summary tables and narrative synthesis were used (PROSPERO, 2022, CRD42022349896). Three randomized trials met inclusion criteria. In two of the trials investigators found that metformin improved clinical outcomes (prevented need for oxygen and prevented need for acute health care use), and in the third trial a larger portion of adults with diabetes were enrolled but results did show a direction of benefit similar to that of the other trials in the per-protocol group. In the largest trial, subjects were enrolled during the delta and omicron waves and vaccinated individuals were included. The certainty of evidence that metformin prevents health care use due to COVID-19 was moderate per Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Many preclinical studies have shown metformin to be effective against SARS-CoV-2.
    Limitations: Limitations include inclusion of only three trials and heterogeneity between trials.
    Conclusions: Future trials will help define the role of metformin in COVID-19 treatment guidelines.
    MeSH term(s) Adult ; Humans ; COVID-19 ; SARS-CoV-2 ; Metformin/therapeutic use ; COVID-19 Drug Treatment ; Bias
    Chemical Substances Metformin (9100L32L2N)
    Language English
    Publishing date 2023-06-20
    Publishing country United States
    Document type Systematic Review ; Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 441231-x
    ISSN 1935-5548 ; 0149-5992
    ISSN (online) 1935-5548
    ISSN 0149-5992
    DOI 10.2337/dc22-2539
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  5. Article ; Online: SMART use of medications for the treatment of adolescent severe obesity: A sequential multiple assignment randomized trial protocol.

    Fox, Claudia K / Vock, David M / Sherwood, Nancy E / Gross, Amy C / Ryder, Justin R / Bensignor, Megan O / Bomberg, Eric M / Sunni, Muna / Bramante, Carolyn T / Jacobs, Nina / Raatz, Sarah J / Kelly, Aaron S

    Contemporary clinical trials

    2024  Volume 138, Page(s) 107444

    Abstract: Background: Severe obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti- ... ...

    Abstract Background: Severe obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti-obesity medication (AOM), such as phentermine and topiramate. However, guidance regarding when adjunct AOM should be started and how AOM should be used is unclear. Furthermore, an inherent limitation of current treatment guidelines is their "one-size-fits-all" approach, which does not account for the heterogeneous nature of obesity and high degree of patient variability in response to all interventions.
    Methods: This paper describes the study design and methods of a sequential multiple assignment randomized trial (SMART), "SMART Use of Medications for the Treatment of Adolescent Severe Obesity." The trial will examine 1) when to start AOM (specifically phentermine) in adolescents who are not responding to lifestyle therapy and 2) how to modify AOM when there is a sub-optimal response to the initial pharmacological intervention (specifically, for phentermine non-responders, is it better to add topiramate to phentermine or switch to topiramate monotherapy). Critically, participant characteristics that may differentially affect response to treatment will be assessed and evaluated as potential moderators of intervention efficacy.
    Conclusion: Data from this study will be used to inform the development of an adaptive intervention for the treatment of adolescent severe obesity that includes empirically-derived decision rules regarding when and how to use AOM. Future research will test this adaptive intervention against standard "one-size-fits-all" treatments.
    MeSH term(s) Adolescent ; Child ; Humans ; Anti-Obesity Agents/therapeutic use ; Anti-Obesity Agents/pharmacology ; Fructose/therapeutic use ; Obesity, Morbid ; Pediatric Obesity/drug therapy ; Phentermine/therapeutic use ; Topiramate/therapeutic use ; Weight Loss ; Randomized Controlled Trials as Topic
    Chemical Substances Anti-Obesity Agents ; Fructose (30237-26-4) ; Phentermine (C045TQL4WP) ; Topiramate (0H73WJJ391)
    Language English
    Publishing date 2024-01-12
    Publishing country United States
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2182176-8
    ISSN 1559-2030 ; 1551-7144
    ISSN (online) 1559-2030
    ISSN 1551-7144
    DOI 10.1016/j.cct.2024.107444
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  6. Article ; Online: Obesity Management in Adults: A Review.

    Elmaleh-Sachs, Arielle / Schwartz, Jessica L / Bramante, Carolyn T / Nicklas, Jacinda M / Gudzune, Kimberly A / Jay, Melanie

    JAMA

    2023  Volume 330, Issue 20, Page(s) 2000–2015

    Abstract: Importance: Obesity affects approximately 42% of US adults and is associated with increased rates of type 2 diabetes, hypertension, cardiovascular disease, sleep disorders, osteoarthritis, and premature death.: Observations: A body mass index (BMI) ... ...

    Abstract Importance: Obesity affects approximately 42% of US adults and is associated with increased rates of type 2 diabetes, hypertension, cardiovascular disease, sleep disorders, osteoarthritis, and premature death.
    Observations: A body mass index (BMI) of 25 or greater is commonly used to define overweight, and a BMI of 30 or greater to define obesity, with lower thresholds for Asian populations (BMI ≥25-27.5), although use of BMI alone is not recommended to determine individual risk. Individuals with obesity have higher rates of incident cardiovascular disease. In men with a BMI of 30 to 39, cardiovascular event rates are 20.21 per 1000 person-years compared with 13.72 per 1000 person-years in men with a normal BMI. In women with a BMI of 30 to 39.9, cardiovascular event rates are 9.97 per 1000 person-years compared with 6.37 per 1000 person-years in women with a normal BMI. Among people with obesity, 5% to 10% weight loss improves systolic blood pressure by about 3 mm Hg for those with hypertension, and may decrease hemoglobin A1c by 0.6% to 1% for those with type 2 diabetes. Evidence-based obesity treatment includes interventions addressing 5 major categories: behavioral interventions, nutrition, physical activity, pharmacotherapy, and metabolic/bariatric procedures. Comprehensive obesity care plans combine appropriate interventions for individual patients. Multicomponent behavioral interventions, ideally consisting of at least 14 sessions in 6 months to promote lifestyle changes, including components such as weight self-monitoring, dietary and physical activity counseling, and problem solving, often produce 5% to 10% weight loss, although weight regain occurs in 25% or more of participants at 2-year follow-up. Effective nutritional approaches focus on reducing total caloric intake and dietary strategies based on patient preferences. Physical activity without calorie reduction typically causes less weight loss (2-3 kg) but is important for weight-loss maintenance. Commonly prescribed medications such as antidepressants (eg, mirtazapine, amitriptyline) and antihyperglycemics such as glyburide or insulin cause weight gain, and clinicians should review and consider alternatives. Antiobesity medications are recommended for nonpregnant patients with obesity or overweight and weight-related comorbidities in conjunction with lifestyle modifications. Six medications are currently approved by the US Food and Drug Administration for long-term use: glucagon-like peptide receptor 1 (GLP-1) agonists (semaglutide and liraglutide only), tirzepatide (a glucose-dependent insulinotropic polypeptide/GLP-1 agonist), phentermine-topiramate, naltrexone-bupropion, and orlistat. Of these, tirzepatide has the greatest effect, with mean weight loss of 21% at 72 weeks. Endoscopic procedures (ie, intragastric balloon and endoscopic sleeve gastroplasty) can attain 10% to 13% weight loss at 6 months. Weight loss from metabolic and bariatric surgeries (ie, laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass) ranges from 25% to 30% at 12 months. Maintaining long-term weight loss is difficult, and clinical guidelines support the use of long-term antiobesity medications when weight maintenance is inadequate with lifestyle interventions alone.
    Conclusion and relevance: Obesity affects approximately 42% of adults in the US. Behavioral interventions can attain approximately 5% to 10% weight loss, GLP-1 agonists and glucose-dependent insulinotropic polypeptide/GLP-1 receptor agonists can attain approximately 8% to 21% weight loss, and bariatric surgery can attain approximately 25% to 30% weight loss. Comprehensive, evidence-based obesity treatment combines behavioral interventions, nutrition, physical activity, pharmacotherapy, and metabolic/bariatric procedures as appropriate for individual patients.
    MeSH term(s) Adult ; Female ; Humans ; Male ; Anti-Obesity Agents/therapeutic use ; Cardiovascular Diseases/epidemiology ; Diabetes Mellitus, Type 2/epidemiology ; Gastric Balloon ; Glucagon-Like Peptide 1 ; Glucose ; Hypertension/epidemiology ; Obesity/diagnosis ; Obesity/epidemiology ; Obesity/therapy ; Obesity Management/methods ; Overweight/diagnosis ; Overweight/epidemiology ; Overweight/therapy ; Peptides ; United States/epidemiology ; Weight Loss ; Body Mass Index
    Chemical Substances Anti-Obesity Agents ; Glucagon-Like Peptide 1 (89750-14-1) ; Glucose (IY9XDZ35W2) ; Peptides
    Language English
    Publishing date 2023-11-17
    Publishing country United States
    Document type Review ; Journal Article
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2023.19897
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  7. Article ; Online: Fish Consumption During Pregnancy: An Opportunity, Not a Risk.

    Bramante, Carolyn T / Spiller, Philip / Landa, Michael

    JAMA pediatrics

    2018  Volume 172, Issue 9, Page(s) 801–802

    MeSH term(s) Adult ; Animals ; Feeding Behavior ; Female ; Food Contamination/statistics & numerical data ; Humans ; Maternal Health/statistics & numerical data ; Pregnancy ; Prenatal Care/statistics & numerical data ; Prenatal Nutritional Physiological Phenomena ; Risk Assessment ; Seafood/adverse effects ; Seafood/statistics & numerical data
    Language English
    Publishing date 2018-07-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2701223-2
    ISSN 2168-6211 ; 2168-6203
    ISSN (online) 2168-6211
    ISSN 2168-6203
    DOI 10.1001/jamapediatrics.2018.1619
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  8. Article ; Online: We Should Do More to Offer Evidence-Based Treatment for an Important Modifiable Risk Factor for COVID-19: Obesity.

    Dutta, Nirjhar / Ingraham, Nicholas E / Usher, Michael G / Fox, Claudia / Tignanelli, Christopher J / Bramante, Carolyn T

    Journal of primary care & community health

    2021  Volume 12, Page(s) 2150132721996283

    Abstract: Observational studies, from multiple countries, repeatedly demonstrate an association between obesity and severe COVID-19, which is defined as need for hospitalization, intensive care unit admission, invasive mechanical ventilation (IMV) or death. Meta- ... ...

    Abstract Observational studies, from multiple countries, repeatedly demonstrate an association between obesity and severe COVID-19, which is defined as need for hospitalization, intensive care unit admission, invasive mechanical ventilation (IMV) or death. Meta-analysis of studies from China, USA, and France show odds ratio (OR) of 2.31 (95% CI 1.3-4.1) for obesity and severe COVID-19. Other studies show OR of 12.1 (95% CI 3.25-45.1) for mortality and OR of 7.36 (95% CI 1.63-33.14) for need for IMV for patients with body mass index (BMI) ≥ 35 kg/m
    MeSH term(s) Awareness ; Body Mass Index ; COVID-19/etiology ; COVID-19/mortality ; COVID-19/prevention & control ; Hospital Mortality ; Hospitalization ; Humans ; Insulin Resistance ; Intensive Care Units ; Intra-Abdominal Fat/metabolism ; Obesity/complications ; Obesity/metabolism ; Obesity/therapy ; Odds Ratio ; Respiration, Artificial ; Risk Factors ; SARS-CoV-2 ; Severity of Illness Index
    Language English
    Publishing date 2021-02-28
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2550221-9
    ISSN 2150-1327 ; 2150-1319
    ISSN (online) 2150-1327
    ISSN 2150-1319
    DOI 10.1177/2150132721996283
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  9. Article ; Online: Metabolic surgery may protect against admission for COVID-19 in persons with nonalcoholic fatty liver disease.

    Tignanelli, Christopher J / Bramante, Carolyn T / Dutta, Nirjhar / Tamariz, Leonardo / Usher, Michael G / Ikramuddin, Sayeed

    Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery

    2021  Volume 17, Issue 10, Page(s) 1780–1786

    Abstract: Background: SARS-CoV-2 (COVID-19) disease causes significant morbidity and mortality through increased inflammation and thrombosis. Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are states of chronic inflammation and ... ...

    Abstract Background: SARS-CoV-2 (COVID-19) disease causes significant morbidity and mortality through increased inflammation and thrombosis. Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are states of chronic inflammation and indicate advanced metabolic disease.
    Objective: The purpose of this observational study was to characterize the risk of hospitalization for COVID-19 in patients with NAFLD/NASH and evaluate the mitigating effect of various metabolic treatments.
    Setting: Retrospective analysis of electronic medical record data of 26,896 adults from a 12-hospital Midwest healthcare system with a positive COVID-19 polymerase chain reaction (PCR) test from March 1, 2020, to January 26, 2021.
    Methods: Variable selection was guided by the least absolute shrinkage and selection operator (LASSO) method, and multiple imputation was used to account for missing data. Multivariable logistic regression and competing risk models were used to assess the odds of being hospitalized within 45 days of a COVID-19 diagnosis. Analysis assessed the risk of hospitalization among patients with a prescription for metformin and statin use within the 3 months prior to the COVID-19 PCR result, history of home glucagon-like peptide 1 receptor agonist (GLP-1 RA) use, and history of metabolic and bariatric surgery (MBS). Interactions were assessed by sex and race.
    Results: A history of NAFLD/NASH was associated with increased odds of admission for COVID-19 (odds ratio [OR], 1.88; 95% confidence interval [CI], 1.57-2.26; P < .001) and mortality (OR, 1.96; 95% CI, 1.45-2.67; P < .001). Each additional year of having NAFLD/NASH was associated with a significant increased risk of being hospitalized for COVID-19 (OR, 1.24; 95% CI, 1.14-1.35; P < .001). NAFLD/NASH increased the risk of hospitalization in men, but not women, and increased the risk of hospitalization in all multiracial/multiethnic subgroups. Medication treatments for metabolic syndrome were associated with significantly reduced risk of admission (OR, .81; 95% CI, .67-.99; P < .001 for home metformin use; OR, .71; 95% CI, .65-.83; P < .001 for home statin use). MBS was associated with a significant decreased risk of admission (OR, .48; 95% CI, .33-.69; P < .001).
    Conclusions: NAFLD/NASH is a significant risk factor for hospitalization for COVID-19 and appears to account for risk attributed to obesity. Other significant risks include factors associated with socioeconomic status and other co-morbidities, such as history of venous thromboembolism. Treatments for metabolic disease mitigated risks from NAFLD/NASH. More research is needed to confirm the risk associated with visceral adiposity, and patients should be screened for and informed of treatments for metabolic syndrome.
    MeSH term(s) Adult ; Bariatric Surgery ; COVID-19 ; COVID-19 Testing ; Hospitalization ; Humans ; Liver ; Male ; Non-alcoholic Fatty Liver Disease ; Retrospective Studies ; SARS-CoV-2
    Language English
    Publishing date 2021-06-29
    Publishing country United States
    Document type Journal Article ; Observational Study
    ZDB-ID 2274243-8
    ISSN 1878-7533 ; 1550-7289
    ISSN (online) 1878-7533
    ISSN 1550-7289
    DOI 10.1016/j.soard.2021.05.029
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  10. Article: Treatment of Obesity in Patients With Diabetes.

    Bramante, Carolyn T / Lee, Clare J / Gudzune, Kimberly A

    Diabetes spectrum : a publication of the American Diabetes Association

    2017  Volume 30, Issue 4, Page(s) 237–243

    Abstract: ... IN ... ...

    Abstract IN BRIEF
    Language English
    Publishing date 2017-11-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2211544-4
    ISSN 1040-9165
    ISSN 1040-9165
    DOI 10.2337/ds17-0030
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