Plant-Based Totum-63 Significantly Lowers Fasting Glucose and HbA1c in Prediabetes and Early Type 2 Diabetes: Study

France: In a recent study published in Diabetes Journal, researchers have demonstrated that Totum-63 (T63), a plant-based substance, significantly improves glucose control in individuals with prediabetes and type 2 diabetes (T2D).

The 24-week multicenter randomized controlled trial, REVERSE-IT, involved participants consuming 5 grams of T63 daily, leading to marked reductions in fasting plasma glucose and HbA1c levels.

“The study highlights the positive effects of a daily dose of 5 grams of T63 in promoting healthy glucose levels and significantly improving glucometabolic parameters in individuals with prediabetes or early-stage type 2 diabetes,” the researchers wrote.

The effectiveness of natural-based products for glycemic management in individuals with prediabetes or early type 2 diabetes is a topic of ongoing debate. To address this, Prof Jean-Marie Bard, president of the French Nutrition Society Scientific Committee, and colleagues conducted the REVERSE-IT study, a multicenter, multi-country prospective trial lasting 24 weeks. The study compared the effects of T63, a plant-based polyphenol-rich product delivered in capsule form, with a placebo (PBO) in this population.

For this purpose, the researchers recruited a total of 636 volunteers (59% women, average age 56.5 ± 9.1 years, BMI 31.7 ± 4.8 kg/m², HbA1c 6.1 ± 0.9%, fasting plasma glucose [FPG] 122 ± 22 mg/dL) from 52 sites across seven European countries between 2020 and 2023. Among the participants, 78.8% had prediabetes (HbA1c 5.9 ± 0.5%, FPG 116 ± 14 mg/dL), while 21.2% were diagnosed with early T2D (HbA1c 6.9 ± 1.2%, FPG 146 ± 30 mg/dL). Participants were randomly assigned in a 1:1:1 ratio to receive either T63 (5 g/day, three times daily), placebo (three times daily), or T63 (5 g/day, twice daily).

The three-times-daily administration was conducted in a double-blind manner, while the twice-daily regimen was open label. General lifestyle advice was also provided to all participants. The study’s primary endpoint was the change in FPG, with secondary outcomes including effects on HbA1c, blood lipids, and body weight.

Study Results

  • Fasting Plasma Glucose (FPG) Reduction:
    • T63 led to a significant decrease in FPG compared to placebo:
      • TID Analysis: Reduction of 5.8 mg/dL
      • BID Analysis: Reduction of 8.1 mg/dL
  • Hemoglobin A1c (HbA1c) Reduction:
    • T63 also resulted in a reduction in HbA1c levels:
      • TID Analysis: Decrease of 0.11%
      • BID Analysis: Decrease of 0.18%
  • Additional Metabolic Benefits:
    • T63 provided modest improvements in lipid parameters and body weight:
      • Weight Loss:
        • TID Analysis: -0.7 kg
        • BID Analysis: -0.8 kg
  • Influence of Baseline Levels:
    • A more pronounced effect on glycemic parameters was observed with higher baseline HbA1c levels:
      • TID Dosing: Linear regression for HbA1c change: -0.35 x HbA1cBL + 2.04
      • BID Dosing: Linear regression for HbA1c change: -0.59 x HbA1cBL + 3.46
  • Tolerability and Compliance:
    • T63 was well tolerated, with compliance rates exceeding 96% across all groups.

“REVERSE-IT is among the largest and most ambitious studies globally focused on non-drug interventions for early dysglycemia, spanning from prediabetes to the initial stages of type 2 diabetes. The findings from this study mark a significant breakthrough for individuals with glycemic impairment and reinforce the data from the pilot study,” said Prof. Bard.

“Healthcare professionals will now have effective solutions to offer their patients, enabling them to evolve their clinical practices beyond lifestyle recommendations alone,” Bard continued.

“The innovative plant-based polyphenol-rich compound, TOTUM-63, effectively regulates fasting plasma glucose and other indicators of glucose dysregulation in individuals with prediabetes and early type 2 diabetes,” the researchers concluded.

Reference:

YOLANDA F. OTERO, PASCAL SIRVENT, ODD ERIK JOHANSEN, VIVIEN CHAVANELLE, ANNIE BOUCHARD-MERCIER, VERONIQUE SAPONE, MAXIME BARGETTO, FLORIAN LE JOUBIOUX, BRUNO PEREIRA, MURIELLE CAZAUBIEL, NATHALIE BOISSEAU, THIERRY MAUGARD, BRUNO GUIGAS, SEBASTIEN PELTIER, JEAN-MARIE BARD, HANS-JUERGEN WOERLE, SAMY HADJADJ, ANDRE MARETTE; 73-OR: The Plant-Based Substance Totum-63 (T63) Reduces Fasting Plasma Glucose and HbA1c in People with Prediabetes or Type 2 Diabetes (T2D)—A 24-Week Multicenter Randomized Controlled Trial (REVERSE-IT). Diabetes 14 June 2024; 73 (Supplement_1): 73–OR. https://doi.org/10.2337/db24-73-OR

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Study finds early TAVR can be beneficial for patients with asymptomatic severe aortic stenosis

The first powered randomized trial examining early intervention with transcatheter aortic valve replacement (TAVR) in patients with asymptomatic, severe aortic stenosis (AS) found this strategy to be both a safe and effective alternative to clinical surveillance (CS).

Findings were reported today at TCT 2024, the annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. Results were also published simultaneously in the New England Journal of Medicine.

For patients with asymptomatic, severe AS and preserved left-ventricular ejection fraction, current guidelines recommend clinical surveillance every six to 12 months. Whether the strategy of early TAVR confers benefits over guideline-indicated clinical surveillance remains to be determined.

From March 2017 through December 2021, 1,578 patients consented for screening at 75 centers in the United States and Canada. A total of 901 patients were randomized to either transfemoral TAVR (n=455) or clinical surveillance (n=446). The mean age was 76 years, 69% were male, the mean Society of Thoracic Surgeons risk score was 1.8%, and 84% of patients were considered low surgical risk per local heart team evaluation. Asymptomatic status was confirmed in more than 90% of patients with a negative treadmill stress test. In addition, the mean Kansas City Cardiomyopathy Questionnaire score at baseline was 92.7 (excellent status). Baseline echo characteristics were also similar between both groups.

The primary endpoint, the composite of death, stroke, or unplanned cardiovascular hospitalization, was evaluated for superiority in the intent-to-treat population after a minimum follow-up of two years. Early TAVR resulted in a significant reduction of the primary endpoint at two years as well as a median follow-up of 3.8 years, occurring 35.1% in the TAVR group compared with 51.2% in the surveillance group [HR (95%CI): 0.50 (0.40, 0.63), p < 0.001].

The secondary endpoint of favorable health status outcome occurred more frequently in the early TAVR group (86.6%) compared with the surveillance group [68.0%, Abs ∆: 18.5% [12.6%, 24.3%], p <0.001].

Left-ventricular and left-atrial health at two years was also better for those who underwent early TAVR [48.1% versus 35.9%, Abs ∆: 12.2% (4.4%, 19.4%), p=0.001]. Change in left-ventricular ejection fraction from baseline to two years, new onset atrial fibrillation, and death or disabling stroke were similar between the two groups.

By two years, more than 70% of the patients in the clinical surveillance group had AVR, with the vast majority becoming symptomatic. The median time to conversion was 11.1 months, with 26% and 47% requiring AVR at 6 months and 1 year, respectively. More importantly, ~40% of patients from the clinical surveillance group presented with acute and advanced signs and symptoms, such as NYHA III-IV heart failure, pulmonary edema, or syncope.

“Given the benefits observed and the lack of harm, early TAVR may be preferred to clinical surveillance in patients with asymptomatic severe AS, especially when combined with the challenges of timely symptom recognition and prompt treatment in real-world settings,” said Philippe Généreux, MD, Director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center. “Not only is early intervention safe and effective, but it also prevents a decline in quality of life for those who later receive TAVR and could prevent the development of cardiac damage.”

Reference:

Study finds early TAVR can be beneficial for patients with asymptomatic severe aortic stenosis, Cardiovascular Research Foundation, Meeting: TCT 2024: Transcatheter Cardiovascular Therapeutics.

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Scientists create a world-first 3D cell model to help develop treatments for devastating lip injuries

We use our lips to talk, eat, drink, and breathe; they signal our emotions, health, and aesthetic beauty. It takes a complex structure to perform so many roles, so lip problems can be hard to repair effectively. Basic research is essential to improving these treatments, but until now, models using lip cells—which perform differently to other skin cells—have not been available.

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One-third of patients with cancer visit emergency departments in months before diagnosis, finds study

About 1 in 3 patients diagnosed with cancer in Ontario visited an emergency department (ED) in the 90 days before diagnosis, found a new study published in the Canadian Medical Association Journal.

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Preventing obesity in very young children could be in the palm of parents’ hands

A study co-led by a Johns Hopkins Children’s Center clinician-researcher shows that adding text messaging and other electronic feedback to traditional in-clinic health counseling for parents about feeding habits, playtime and exercise prevents very young children from developing obesity and potentially lifelong obesity-related problems.

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Mpox cases in Congo may be stabilizing. Experts say more vaccines are needed to stamp out virus

Some health officials say mpox cases in Congo appear to be “stabilizing”—a possible sign that the main epidemic for which the World Health Organization made a global emergency declaration in August might be on the decline.

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Warning for younger women: Be vigilant on breast cancer risk

Breast cancer rates rose by 1% a year from 2012–2021 for all American women combined, but steeper increases were seen for women under 50 and Asian American and Pacific Islander women, according to the American Cancer Society, which released its biennial report in October 2024 on the state of the disease in the nation.

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Reevaluating Preoperative Fasting in Children: Review Provides Insights on Guidelines, Aspiration Risks, and Safety Measures

Sweden: A recent review published in Best Practice & Research Clinical Anaesthesiology has highlighted the evolution of recommendations and guidelines regarding preoperative fasting in children and the supporting evidence behind these changes.

The review by Peter Frykholm, Uppsala Centre for Paediatric Anaesthesia and Intensive Care Research, Uppsala University Hospital, Uppsala, Sweden, and colleagues explores the development of preoperative fasting guidelines and evaluate the incidence of pulmonary aspiration of gastric contents, along with recommended treatment approaches.

Since 1994, nine guidelines developed by professional societies and published in peer-reviewed journals have been identified regarding preoperative fasting in pediatric anesthesia. Over the past three decades, recommendations for fasting across various categories have seen only minor adjustments.

The review also identified twelve studies on the incidence of pulmonary aspiration, reporting rates ranging from 0.6 to 12 cases per 10,000 anesthetics in children. This variation is influenced by differing definitions of aspiration and variations in study design. Key risk factors associated with pulmonary aspiration include emergency surgery, ASA physical status, and patient age. Additionally, non-compliance with fasting guidelines has been noted as a potential risk factor.

Interestingly, the duration of fasting from clear fluids does not appear to be linked to an increased risk of pulmonary aspiration, suggesting that this finding may inform future updates to guidelines in pediatric anesthesia. 

According
to the research, the following were the practice points:

  • Low Mortality Risk: Pulmonary aspiration
    of gastric contents in healthy children does not result in mortality.
  • Declining Incidence: The rate of
    aspiration requiring escalation of care or intensive care has decreased
    significantly over the past 30 years, by one order of magnitude.
  • Clear Fluid Safety: Aspiration of clear
    fluids consumed before anesthesia has not been linked to significant
    morbidity or mortality.
  • Risk Factor Identification: Identifying
    patients with aspiration risk factors and adjusting the airway management plan
    accordingly may be the most effective strategy to prevent pulmonary aspiration.
  • Immediate Response: Prompt recognition
    and management of regurgitation during all phases of anesthesia—induction,
    maintenance, and emergence—are crucial for minimizing potential harm to
    patients.

The study revealed that pulmonary aspiration of clear gastric contents in children is rare and typically does not result in complications. Over the past 50 years, only two reported cases have linked aspiration to fatalities. The incidence of pulmonary aspiration requiring postoperative intensive care has significantly decreased, now ranging from 0.2 to 3 cases per 10,000 anesthetics, marking a reduction of one order of magnitude. Similarly, instances of aspiration that necessitate escalated care—such as unplanned admissions, supplemental oxygen beyond the post-anesthesia care unit (PACU), or antibiotic treatment—have also declined, with reported rates between 0.4 and 3 cases per 10,000.

Furthermore, regurgitation leading to transient symptoms, including intraoperative desaturation, coughing, or the need for suctioning of regurgitated gastric contents, occurs at an incidence of 0.6 to 10 cases per 10,000.

While preoperative fasting for solids remains critical, recent findings suggest that clear fluids can be consumed closer to induction than previously recommended. Introducing new fasting guidelines, which advocate for a one-hour limit on clear fluid intake, is safe and effective in minimizing fasting durations.

“Nevertheless, even with adherence to fasting guidelines, ensuring a completely empty stomach in pediatric patients remains uncertain. Therefore, the anesthesia team must remain vigilant regarding the risk factors associated with aspiration, recognizing that clear fluid fasting duration does not appear to be one of them. Prompt identification and management of regurgitation during all phases of anesthesia—induction, maintenance, and emergence—are essential to mitigate potential patient harm,” the researchers concluded.

Reference:

Frykholm, P., Hansen, T. G., & Engelhardt, T. (2024). Preoperative fasting in children. The evolution of recommendations and guidelines, and the underlying evidence. Best Practice & Research Clinical Anaesthesiology, 38(2), 103-110. https://doi.org/10.1016/j.bpa.2024.03.003

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Low-Dose Aspirin may increase Risk of Anaemia in Older Adults: Study

Low-Dose Aspirin may increase Risk of Anaemia in Older Adults suggests a study published in the European Heart Journal.

A study was done to assess the risk of anaemia among low-dose aspirin (LDA) exposure in Danish older individuals in a real-world setting. Population based-cohort study conducted using Danish registers. The study population included older individuals (≥65 years) exposed to LDA between 2008 and 2013 for primary or secondary prevention of cardiovascular events. Over a five-year follow-up, outcomes included anaemia incidence based on haemoglobin values and hematinic deficiency incidence based on antianemic prescriptions.

Results: Among the 313 508 individuals included in the study population, those exposed to LDA (n = 59 869, 19.1%) had an incidence of hematinic deficiency determined by the use of antianemic treatment of 9.6%, with an incidence rate ratio of 9.11 (95% Confidence Interval, CI: 8.81-9.41) when compared to non-users of LDA (n = 253 639, 80.9%), who had an incidence of 3.7%. Anaemia determined by haemoglobin value measurements was observed in 5.9% of those exposed to LDA, with an incidence rate ratio of 7.89 (95% CI: 7.58-8.21) when compared to non-users of LDA. Approximately one in five individuals (n = 2 422, 21.5%) who experienced anaemia also experienced bleeding. Severe anaemia was observed in 1.3% of those exposed to LDA compared to 0.6% of those not exposed. Among the exposed, the reduction in haemoglobin and ferritin levels was associated with the severity of anaemia. These findings indicate that in a real-world setting, anaemia with LDA can occur in 6 to 10 older individuals out of every 100 LDA users during the first 5 years of treatment.

Reference:

Maria Antonietta Barbieri, Dilsad Simay Peker, Mohsen Gamal Saad Askar, Vera Battini, Andrea Abate, Carla Carnovale, Emilio Clementi, Richard Ofori-Asenso, Edoardo Spina, Manan Pareek, Kristian Kragholm, Christian Torp-Pedersen, Maurizio Sessa, Low-Dose Aspirin and Risk of Anaemia in Older Adults: Insights from a Danish Register-based Cohort Study, European Heart Journal – Quality of Care and Clinical Outcomes, 2024;, qcae089, https://doi.org/10.1093/ehjqcco/qcae089

Keywords:

Low-Dose, Aspirin, increase, Risk, Anaemia, Older, Adults, Study, Maria Antonietta Barbieri, Dilsad Simay Peker, Mohsen Gamal Saad Askar, Vera Battini, Andrea Abate, Carla Carnovale, Emilio Clementi, Richard Ofori-Asenso, Edoardo Spina, Manan Pareek, Kristian Kragholm

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First-line thioguanine therapy effective in patients with thiopurine-naïve IBD: Study

A recent study published in the journal of Inflammatory Bowel Diseases showed that first-line thioguanine treatment was clinically beneficial at 12 months with an acceptable safety profile in 53% of patients with thiopurine-naïve inflammatory bowel disease.

2 well-known maintenance medications for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) are azathioprine and mercaptopurine. Even though they work well to keep patients in remission, up to 40% of patients must stop their treatment because of unfavorable side effects. Thioguanine has a less complex metabolism than azathioprine and mercaptopurine. It is directly transformed into the pharmacologically active 6-thioguaninucleotides (6-TGNs) by HGPRT (hypoxanthine-guanine phosphoribosyltransferase) without the production of potentially harmful metabolites like 6-MMP (6-methylmercaptopurine).

As of now, thioguanine is only utilized to treat inflammatory bowel disease in cases where azathioprine and/or mercaptopurine have failed. This research was to evaluate the safety, efficacy, and 12-month drug survival of thioguanine in patients with inflammatory bowel disease who had never taken thiopurine.

The patients with inflammatory bowel disease who had not taken thiopurine before and were receiving thioguanine as their first thiopurine derivative participated in this retrospective cohort study. The maintenance of thioguanine without the (re)initiation of concomitant biological treatment, systemic corticosteroids, or surgery was considered clinically successful. The Common Terminology Criteria for Adverse Events were used to categorize each adverse event.

A total of 114 patients participated with a median therapy duration of 25 months and a median thioguanine dose of 20 mg/d. 53% of patients showed clinical efficacy at 12 months, and 78% of these responding patients continued to show improvement until the conclusion of the follow-up period.

Over the course of the follow-up period, 26 patients were defined as initial non-responders, 8 experienced a subsequent loss of response and 11 patients were deemed non-responders because they were unable to stop using systemic corticosteroids within 6 months. 86% of the patients were still using thioguanine a year later.

9 patients (8%) stopped their medication as a result of adverse events, and 50 (44%) patients experienced grade 1 or 2 adverse events. 3 people were infected, although none of them required hospitalization, and 2 other patients had pancytopenia. No evidence of portal hypertension or nodular regenerative hyperplasia was seen.

Overall, first-line thioguanine treatment had clinical efficacy rates comparable to normal azathioprine/mercaptopurine therapy at 12 months. Future studies in a more prospective and controlled setting should investigate the prospective function of thioguanine as first-line treatment for IBD.

Reference:

Crouwel, F., Bayoumy, A. B., Mulder, C. J. J., Peters, J. H. C., Boekema, P. J., Derijks, L. J. J., de Boer, S. Y., van de Meeberg, P. C., Ahmad, I., Buiter, H. J. C., & de Boer, N. K. (2023). The Effectiveness and Safety of First-Line Thioguanine in Thiopurine-Naïve Inflammatory Bowel Disease Patients. In Inflammatory Bowel Diseases (Vol. 30, Issue 9, pp. 1492–1499). Oxford University Press (OUP). https://doi.org/10.1093/ibd/izad197

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