Time-restricted eating associated with greater blood sugar control and fat loss than standard nutrition counseling

Embargoed for release until 5:00 p.m. ET on Monday 30 September 2024  

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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.       
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1. Time-restricted eating associated with greater blood sugar control and fat loss than standard nutrition counseling

Abstract: https://www.acpjournals.org/doi/10.7326/M24-0859  

Summary for Patients: https://www.acpjournals.org/doi/10.7326/P24-0006  

URL goes live when the embargo lifts        

A randomized control trial of adults with metabolic syndrome evaluated the effect of time-restricted eating (TRE) on glucose control, fat mass, and weight loss. The data revealed that TRE led to greater modest improvement in glucose control and decreases in weight and fat mass when coupled with standard nutritional counseling than standard nutritional counseling alone. The study is published in Annals of Internal Medicine.

Researchers from the The Salk Institute and UCSD Medicine studied data from 108 adult participants with metabolic syndrome (MetS), elevated BMI, and elevated HbA1c or fasting glucose characteristic of prediabetes. They aimed to assess the efficacy of personalized TRE in participants on top of standard nutritional counseling to determine the effects of TRE as a lifestyle intervention. Researchers randomly assigned participants into two groups that had different interventions; in the first group, participants were given standardized lifestyle and nutritional recommendations and advised to continue their eating patterns. The second group was given the same nutritional recommendations, but they were also assigned to a personalized 8 to 10 hour eating window. Researchers remotely monitored the intervention for three months, during which the participants logged the timing of dietary intake in the myCircadianClock (mCC) app every day. The primary outcome was changes in fasting glucose, while secondary outcomes included changes in HbA1c and cardiometabolic parameters. Results found that, compared to the group receiving standard nutritional guidance, the TRE group not only had a greater decrease of weight, but a higher proportion of the weight lost was from fat—suggesting TRE likely poses a lower risk for deterioration of muscle associated with weight loss. Further, while the changes were modest, the TRE group observed greater improvement in blood sugar control and hemoglobin A1c levels. Ultimately, the data indicates that TRE is an effective practical lifestyle intervention with benefits for glycemic regulation and cardiometabolic health. The study contributes to the library of existing research on TRE and metabolic syndromes. In addition, its methodological innovation in using the mCC app enables future studies to be remote and at a larger scale.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Satchidananda Panda, PhD, please email panda@salk.edu. To speak with corresponding author Pam R. Taub, MD, please email ptaub@ucsd.edu.

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2. NIH Panel concludes COVID-19 guidelines, provides final treatment recommendations

Final guidelines provide insight into lessons learned for developing clinical guidelines in future emergency situations

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-00464    

URL goes live when the embargo lifts       

The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel released its final set of recommendations on February 29, 2024. This article includes a copy of the final guidelines and incorporates perspectives and lessons learned as the public health emergency ended. Convened in March 2020 at the request of the U.S. Department of Health and Human Services, the expert panel developed "living" guidelines, that were continuously updated as new data emerged and designed to be accessible to clinicians. Over the past four years, the panel provided treatment strategies for COVID-19 using FDA-approved and -authorized antiviral therapies and immunomodulators. Further recommendations will now transition to professional societies. The details are published in Annals of Internal Medicine.

According to the Panel, the final guidelines benefitted from the availability of 4 FDA-approved drugs for the treatment of COVID-19 as well as numerous well-conducted clinical trials that demonstrated the value of antiviral drugs, immunomodulators and other interventions and the lack of benefit of several other purported therapies that were promoted. The Panel’s treatment recommendations were organized by disease severity and were divided into nonhospitalized and hospitalized patient categories. For nonhospitalized patients the guidelines recommend early symptom management and antiviral use, especially in patients at high risk for progression to severe disease. For hospitalized patients, treatment to prevent further disease progression focuses on early intervention with remdesivir and treatment with dexamethasone, if needed. The Panel also recommended controlling inflammation and preventing blood clots with blood thinners in those not at increased risk for bleeding.

Included in this article is a summary of lessons learned during the pandemic. These lessons informed the guidelines, which were developed in full transparency to ensure credibility and objectivity. According to the Panel, these guidelines and the processes used to develop them should give professional societies a template they can follow when managing public health emergencies or pandemics in the future.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with an author from the NIH, please email Kathy Donbeck at NIH kathy.donbeck@nih.gov or Krystle Lopez at Weill Cornell Medicine krl2003@med.cornell.edu.

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3. For anemic patients suffering heart attacks, lower hemoglobin thresholds for transfusion may increase risk of death or recurrent heart attack

Abstract: https://www.acpjournals.org/doi/10.7326/M24-0571

Editorial: https://www.acpjournals.org/doi/10.7326/M24-0895

URL goes live when the embargo lifts  

A prespecified secondary analysis of the MINT (Myocardial Ischemia and Transfusion) trial estimated the effect of 4 strategies to inform an optimal hemoglobin threshold for transfusion among anemic patients suffering from myocardial infarction (MI). The data revealed that 30-day risks for death or recurrent MI among patients seem to increase progressively with lower hemoglobin concentration thresholds for transfusion. The study is published in Annals of Internal Medicine.

Researchers funded by the National Heart, Lung, and Blood Institute studied data from 3,492 MINT trial participants with acute MI and anemia at 144 clinical sites in 6 countries.  Participants were selected if they were 18 years or older, had type 1, 2, 4b, or 4c MI, and had a hemoglobin concentration below 10 g/dL. Researchers used target trial emulation methods to assess 4 transfusion strategies with hemoglobin thresholds of <10 g/dL, <9 g/dL, <8 g/dL, or <7 g/dL to trigger red blood cell (RBC) transfusion. The primary outcome of the study was a composite of all-cause death or recurrent MI, while a secondary outcome was all-cause death. Participants were followed until death, loss to follow-up or withdrawal, or day 30, whichever occurred first. The study design was innovative, with researchers synthesizing data from the MINT trial to conduct this secondary analysis that complemented the results of the former trial. The data suggested that risk for 30-day death or MI was higher for hemoglobin transfusion thresholds of less than 8 g/dL and less than 7 g/dL but did not differ for a threshold of less than 9 g/dL, each relative to a less than 10 g/dL threshold, indicating a possible relationship between low hemoglobin concentration thresholds for transfusion and an elevated 30-day risk for death or MI.  The lower the threshold, seemingly the higher the risk. The results from this study inform the optimal transfusion threshold for this patient population and may help to guide clinical practice in patients with acute MI. These findings suggest that transfusion guidelines could consider avoiding hemoglobin triggers of less than 8 g/dL and less than 7 g/dL in patients with acute MI to minimize risk for hazardous outcomes.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org.  To speak with corresponding author Maria M. Brooks, PhD, please e-mail mbrooks@pitt.edu.

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4. Population-based suicide care program yields 25% reduction in suicide attempts

Abstract: https://www.acpjournals.org/doi/10.7326/M24-0024  

URL goes live when the embargo lifts        

A stepped-wedge, cluster randomized implementation trial found that suicide reduction measures integrated into primary care resulted in a 25% reduction in suicide attempt rate when implemented alongside a substance use care program. These findings support primary care-based suicide prevention strategies and align with previous research on the effectiveness of the Zero Suicide Model in reducing suicide attempts and deaths. The findings are published in Annals of Internal Medicine.

More than 40% of persons who die by suicide see a primary care clinician in the month before death and more than 75% in the year before suicide death. Therefore, primary care teams may have important opportunities to engage at-risk patients in early intervention efforts. Researchers from Kaiser Permanente Washington Health Research Institute conducted a secondary analysis of a stepped-wedge, cluster randomized implementation trial to evaluate the effectiveness of implementing population-based suicide care in primary care for suicide attempt prevention. In the study, 22 primary care practices were selected to test a program that combined care for both mental health issues, like depression, and substance use. The practices were divided into seven "waves," which were gradually introduced to the program. Random assignment was used to determine which practices joined the program first, starting in 2016. Patients were screened annually using a short survey to assess depression, alcohol, and drug use and clinicians used this information to identify and treat patients struggling with these issues early so that they could provide better care overall. The researchers found that in the 90 days after the primary care visits, documented suicide attempts fell to 1.5 per 10,000 visits. Key elements of the Zero Suicide model, such as depression screening, risk assessment, and safety planning, were credited for this decline. According to the researchers, the findings from this study may provide vital evidence for health care teams considering how to respond to patient-reported suicidality during routine primary care encounters, as well as for organizational leaders considering the value of integrating clinical practices in primary care to support suicide prevention.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. . To speak with corresponding author Julie Angerhofer Richards, PhD, MPH, please e-mail Amelia Apfel at Amelia.X.Apfel@kp.org.

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5. Very few patients with abnormal urine protein dipstick results have recommended follow-up testing for early kidney disease

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-00549 

URL goes live when the embargo lifts       

A study of more than 1 million health records found that very few patients with abnormal urine protein dipstick results had follow-up testing for early kidney disease by albuminuria testing as recommended by clinical guidelines. The follow-up albuminuria testing rate was higher, although still low, among people with diabetes, likely due to annual albumin–creatinine ratio (ACR) testing recommendations by the American Diabetes Association. These findings are important because detecting albuminuria level with ACR testing can identify patients at elevated risk for heart and kidney disease and could determine whether treatment is needed. The brief research report is published in Annals of Internal Medicine.

Albuminuria is when a protein called albumin is found in urine at higher-than-normal levels, which can indicate kidney damage. Detecting albumin is important because if confirmed, it signifies kidney disease and increased risk for heart disease, stroke, and death. Researchers from Geisinger Health (Danville, Pennsylvania), Johns Hopkins University (Baltimore, MD), and New York University (New York City, NY) used anonymous electronic health record data from a large database to identify adults who had a doctor’s visit in 2021 that included a blood test to check kidney function and a urine dipstick to test for the presence of protein. People who had a known condition that may cause protein in their urine were excluded from the study. Of 1,042,740 people tested across 33 U.S. health systems, 13% had abnormal protein levels. Within one year, only 6.7% of those with abnormal results had further testing for albuminuria, compared to 4% of those with normal results. Follow-up testing rates were slightly higher but still low for those with more abnormal protein levels. Of those who had follow-up tests, 43.3% had confirmed albuminuria, with higher protein levels on the initial test linked to a higher chance of confirmation. According to the study authors, these findings show a crucial opportunity to better identify patients with kidney disease through follow-up ACR testing after abnormal protein dipstick results, allowing patients to reduce their heart and kidney risk with appropriate therapies.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Alexander R. Chang, MD, MS, please e-mail achang@geisinger.edu.

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Also new in this issue:

The Misplaced Push to Restrict Access to Gabapentin

Geoff Hollett, PhD; Karen Dionesotes, MD, MPH; Joshua M. Cohen, MD, MPH; Noel Deep, MD; and Jennie B. Jarrett, PharmD, MMedEd, PhD

Ideas and Opinions

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-00940