'Yo-Yo Dieting' Could Be Hard on Kidneys in Type 1 Diabetes Patients, Among Others

 

• Greater weight variability was linked with worse kidney outcomes in type 1 diabetes.
• Patients had a higher risk for eGFR decline, doubling of serum creatinine, and stage 3 chronic kidney disease over 6 years.
• Risk of moderate or severe albuminuria was not significant.

Body-weight cycling, sometimes referred to as yo-yo dieting, may be harmful to the kidneys for people with type 1 diabetes, according to retrospective data analysis.

Among 1,432 people with type 1 diabetes, high variability of average body weight was associated with a 25% higher risk of experiencing a 40% decline in estimated glomerular filtration rate (eGFR) over an average 6-year follow-up (HR 1.25, 95% CI 1.09-1.41, P=0.001), reported Marion Camoin, MD, of Bordeaux University Hospital in France, and colleagues in the Journal of Clinical Endocrinology & Metabolismopens in a new tab or window.

Greater weight variability also was associated with significantly higher risks for a few other negative renal outcomes, which were adjusted for several variables including baseline eGFR, HbA1c, and use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs):

• Doubling of baseline serum creatinine: HR 1.34 (95% CI 1.13-1.57, P=0.001)
• Stage 3 chronic kidney disease: HR 1.36 (95% CI 1.12-1.63, P=0.002)
• Rapid decline in eGFR (decline >3 mL/min/m² per year): OR 1.49 (95% CI 1.15-1.93, P=0.003)

There was also a trend towards an increased risk for moderate albuminuria (urinary albumin excretion rate 30-300 mg/24 hours) and severe albuminuria (>300 mg/24 hours), though this didn't reach significance after adjustment.

Body-weight cycling isn't uncommon in the general population, with an estimated prevalence up to 35% in men and 55% in women. Drivers behind weight cycling "can be multiple and complex, involving genetic, environmental, and pharmacological factors, along with behavioral, lifestyle, and dietary influences often shaped by body perception," the researchers said.

Repeatedly gaining and losing weight several times is known to have a "deleterious impact" on risk of cardiovascular events and all-cause mortality, but this is the first study to report associations with the risk of renal events in people with type 1 diabetes.

"In type 1 diabetes, insulin therapy may play a particularly significant role in driving body-weight cycling due to the anabolic effects of the hormone," Camoin and colleagues pointed out. "Weight loss can result from suboptimal insulin therapy, while weight gain is commonly associated with improved glycemic control. Additionally, the hypoglycemia risk associated with insulin use may lead to defensive snacking and reduced physical activity."

They advised that "strategies aimed at weight reduction in people with type 1 diabetes should focus on promoting long-term weight maintenance, as weight stability may have a positive impact on health outcomes."

Data for the analysis came from the Diabetes Control and Complications Trialopens in a new tab or window (DCCT) and the post-trial observational follow-up, the Epidemiology of Diabetes Interventions and Complicationsopens in a new tab or window (EDIC) study. The randomized DCCT reported benefits of intensive glycemic control (blood glucose goal between 70-120 mg/dL) on microvascular complications. It enrolled 1,441 participants with type 1 diabetes between ages 13 and 39 from 1983 to 1993.

Camoin's group used four indices of intraindividual variability of body weight using annual body-weight data. Participants in the highest tertile for body-weight variability were more likely to be women (59% vs 35%) and younger (25 vs 29 years) compared to those with the most stable body weight. They also had a lower baseline BMI (23.1 vs 23.5), higher HbA1c (9.1% vs 8.7%), and a higher eGFR (129 vs 124 mL/min/1.73 m²).

Those with the highest body-weight variability were also more likely to have been allocated to the DCCT study intensive treatment group (50% vs 39%). The researchers noted that during the trial, frequent nonsevere episodes of hypoglycemia during intensive glucose control were associated with subsequent weight gain.

During follow-up, 18.8% of participants experienced a 40% decline in eGFR from baseline, 8.6% had a doubling of baseline serum creatinine, and 8.9% progressed to stage 3 chronic kidney disease (eGFR <60 mL/min/1.73 m²). The highest tertile for body-weight variability had an eGFR change of -1.73 mL/min/1.73 m² per year compared with -1.51 mL/min/1.73 m² per year for those with more stable weight.

Camoin's group didn't have information of the underlying cause of body-weight variability, limiting the generalizability of the findings. Also, data for the cohort was obtained in 1983 and type 1 diabetes management has greatly evolved since then.

"[I]t would be interesting to confirm these results with more recent data," they concluded.

Disclosures

Camoin disclosed relationships with Boehringer-Ingelheim, Eli Lilly, Sanofi, and Pierre Fabre.

Co-authors disclosed relationships with Novo Nordisk, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Sanofi, Lifescan, Abbott, Bayer, Amarin, Grunenthal, MSD, Servier, Valbiotis, Novartis, Dinno Santé and Pierre Fabre Santé, Bristol-Myers Squibb, Gilead, Pfizer, Dexcom, Alphadiab, Medtronic, and Air Liquide.

Primary Source

The Journal of Clinical Endocrinology & Metabolism

Source Reference: opens in a new tab or windowCamoin M, et al "Body-weight cycling and risk of diabetic kidney disease in people with type 1 diabetes in the DCCT/EDIC population" J Clin Endocrinol Metab 2025; DOI: 10.1210/clinem/dgae852.

https://www.medpagetoday.com/nephrology/diabetes/114070

Hydroablation Device Shows Promise for Early Prostate Cancer

 

• A hydroablation device for benign prostatic hyperplasia showed promise as a potential treatment aid for early prostate cancer in a small Chinese study.
• The proportion of patients with detectable circulating tumors cells increased immediately after treatment, then declined to below pretreatment numbers.
• Prostate symptoms improved, sexual function was preserved, and MRI showed no prostate lesions at 6 months

A hydroablation device developed for benign prostatic hyperplasia (BPH) showed promise as a potential treatment aid for early prostate cancer, according to results of a preliminary study from China.

Men in active surveillance for prostate cancer with symptomatic lower urinary tract symptoms (LUTS) had an early spike in circulating tumors cells (CTCs) after treatment, followed by a decrease to below baseline levels. MRI-detected prostate lesions had disappeared 6 months after Aquablation treatment.

In addition, prostate symptoms improved and sexual function remained stable or improved, reported Jeremy Yuen Chun Teoh, MD, of the Prince of Wales Hospital and the Chinese University of Hong Kong, and co-authors in Urologyopens in a new tab or window.

"In an active surveillance population, Aquablation resulted in improved urinary function, stable or improved sexual function, and a transient spike in CTCs lasting less than 2 days that did not result in any oncologic concern," the authors noted. "Aquablation may be considered a safe option for men with localized prostate cancer who require treatment for LUTS due to BPH."

Noting that the study involved only five patients, the authors of an accompanying editorialopens in a new tab or window nonetheless were impressed by the results and called for further investigation of the hydroablation device in prostate cancer.

"While the significance of CTCs remains debatable, these results suggest that Aquablation among this cohort does not worsen oncologic symptoms," wrote Greg Raster, MD, of the University of Chicago, and Brian T. Helfand, MD, of Endeavor Health in Evanston, Illinois. "Rather, Aquablation appeared to also eliminate MRI lesions in all patients, suggesting this therapy may also be a suitable treatment for these types of cancer patients. The data support further exploration into this exact question, whether Aquablation can be used as treatment for both BPH and prostate cancer."

"If Aquablation ultimately becomes a viable treatment for prostate cancer, it would be different from almost all other focal therapy," Raster and Helfand added. "Specifically, Aquablation has the potential to treat increasing amounts of tissue bilaterally within the prostate without a proportional increased risk in side effects. Taken together, this makes Aquablation a very attractive candidate for this dual purpose."

The Aquablation system initially received FDA approval in 2017 for treatment of LUTS secondary to BPH. The FDA cleared the artificial intelligence-assisted robotic Hydros system for water ablation last yearopens in a new tab or window. The system uses a high-intensity waterjet to remove tissue, as compared with other technologies that ablate tissue in situ, Teoh and colleagues noted in their introduction.

A theoretical concern is the potential for spillage of CTCs.

"Any physical manipulation of the prostate, be it digital rectal exam, biopsy, surgery, TURP [transurethral resection of the prostate], or enucleation, has the theoretical potential to cause tumor cells to shed for a transient period of time," the study authors wrote. "The magnitude of actual CTC release is minute and inconsequential in comparison to the integral release of naive localized prostate cancer and there is a substantial body of evidence supporting the lack of metastatic risk posed by physical diagnostic or treatment manipulation of the prostate."

A recent meta-analysisopens in a new tab or window of 12 studies involving a total of 1,917 men with prostate cancer showed no significant association between pretreatment levels of primary CTCs and biochemical recurrence. Teoh and colleagues conducted a pilot study to determine whether Aquablation could lead to metastatic seeding by means of CTCs released into the circulation.

The five patients enrolled in the trial had a mean age of 63.4, a baseline prostate-specific antigen (PSA) level of 8.9 ng/mL, and a mean prostate volume of 60.3 mL. All of the men had visible prostate lesions by multiparametric MRI (grade group 1) and were considered candidates for active surveillance. They also had LUTS, with an International Prostate Symptom Score (IPSS) of 18.2. Treatment was by robotic-assisted bilateral hydroablation of the prostate. The primary outcome was CTC counts in serial blood sample draws.

Four patients had detectable CTCs before treatment. All five had detectable CTCs immediately after treatment, two had detectable CTCs on post-treatment day 2, and three on day 7. The CTC count per patient was 1.2, 3.2, 0.2, and 1.0 on the four assessment days. Prostate volume decreased to a mean of 37.1 mL at 3 months and was 37.8 mL at 6 months (P<0.05 vs baseline). PSA level declined to 4.6 ng/mL at 3 months (P<0.01) before rebounding slightly to 5.6 ng/mL at 6 months (P<0.05 vs baseline).

The investigators observed no disease progression by MRI, and none of the patients had visible prostate lesions at the 6-month assessment by MRI. Three patients had negative prostate biopsies, and two had grade group 1 disease.

The mean IPSS score decreased to 8.2 at 3 months and was 9.2 at 6 months. Sexual function assessments showed no significant change or improvement from baseline at 3 and 6 months.

The FDA has approved a pivotal randomized clinical trialopens in a new tab or window to compare Aquablation and radical prostatectomy in men with grade group 1-3 localized prostate cancer.

Disclosures

The study was supported by Procept BioRobotics.

Teoh disclosed a relationship with Procept BioRobotics.

Helfand disclosed a relationship with Procept BioRobotics.

Raster reported no relevant relationships with industry.

Primary Source

Urology

Source Reference: opens in a new tab or windowTeoh JYC, et al "Robotic waterjet resection for men with prostate cancer suffering from lower urinary tract symptoms" Urology 2025; DOI: 10.1001/j.urology.2025.01.020.

Secondary Source

Urology

Source Reference: opens in a new tab or windowRaster G, Helfand BT "Aquablation safety and outcomes among men with prostate cancer" Urology 2025; DOI: 10.1016/j.urology.2025.01.058.

https://www.medpagetoday.com/hematologyoncology/prostatecancer/114080

7 Charged In America's Biggest COVID Tax Credit Fraud Scheme

 by Naveen Athrappully via The Epoch Times,

A group of seven who allegedly sought to steal hundreds of millions of dollars in the country’s “largest COVID-19 tax credit scheme” by falsely claiming pandemic-era benefits were charged on Jan. 22, according to the Department of Justice (DOJ).

An indictment unsealed in New York state charged the seven people with “operating a multi-state conspiracy in which they attempted to defraud the United States of more than $600 million by filing more than 8,000 false tax returns claiming COVID-19-related employment tax credits,” the agency said in a statement. The fraud targeted programs like the employee retention credit (ERC) and the paid sick and family leave credit (SFLC), which were passed in response to the COVID-19 pandemic.

The ERC gave tax credits to businesses, incentivizing them to keep employees on their payroll, while SFLC was a reimbursement made to businesses to support employees who were “on sick or family leave and could not work because of COVID-19.”

The charges were made against Keith Williams, Jamari Lewis, Morais Dicks, Janine Davis, Tiffany Williams, James Hames Jr., and Ewendra Mathurin; all of whom are either current or former residents of New York.

Between November 2021 and June 2023, the defendants “repeatedly exploited” ERC and SFLC programs, the DOJ said.

“The scheme was allegedly headquartered at Credit Reset, a purported credit repair business Keith Williams owned and operated.”

The defendants acted as tax preparers and allegedly filed over 8,000 fake employment tax returns on behalf of themselves and clients, claiming COVID tax credits from the IRS. In some of the fake returns, they allegedly claimed SFLC which exceeded reported wages, according to the department.

The defendants managed to secure refund checks from the Treasury, while also profiting by charging clients a fee or percentage of the tax refunds they received, the agency accused.

“The defendants allegedly concealed their preparation of the false tax returns by not listing themselves as the paid preparer on the tax returns and by using Virtual Private Networks (VPNs) to obscure their IP addresses while filing the false returns,” the DOJ said.

“If a client did not have a business, members of the conspiracy allegedly would sometimes sell shell companies to them in order to file false tax returns.”

The fraudsters reportedly filed for $600 million in tax credits as part of the scheme, of which the IRS disbursed about $45 million. Authorities charged the defendants with 45 criminal counts, including wire fraud, conspiracy to defraud the United States, and assisting in preparing false tax returns.

Some of the defendants also allegedly submitted false applications for loans under the pandemic-era Paycheck Protection Program (PPP). Six people allegedly involved in the PPP fraud were charged with wire fraud as well.

If convicted, the defendants face prison terms ranging from three to 30 years per count, depending on the charge.

Tackling Pandemic Fraud

The DOJ had previously charged several hundred individuals with fraud related to COVID-19. In August 2023, the agency announced 718 enforcement actions for alleged COVID-19 fraud offenses involving $836 million. This included federal criminal charges against 371 defendants.

Many of the cases involved pandemic unemployment insurance benefit fraud, as well as fraud related to the Economic Injury Disaster Loans and PPP.

In March last year, the IRS announced that its Criminal Investigation (CI) unit had investigated 1,644 tax and money laundering cases worth $8.9 billion that were linked to COVID fraud.

The cases involved fraudulently obtained loans, payments, and credits aimed at supporting American workers and small businesses.

“In the last year alone, we have opened nearly 700 new COVID fraud investigations that collectively add up to $5 billion in potential fraud,” CI Chief Guy Ficco said at the time. “Our special agents continue to seek out fraudsters who stole money from government loan programs for their personal gain.”

This month, Sen. Joni Ernst (R-Iowa) announced the introduction of the “Complete COVID Collections Act” that seeks to extend authorization of the Special Inspector General for Pandemic Recovery (SIGPR) through 2030.

SIGPR, created as a watchdog to oversee loans provided under the Coronavirus Aid, Relief, and Economic Security Act, is scheduled to expire in March 2025. Extending the authorization allows the SIGPR to continue pursuing people who stole COVID funds reserved for small businesses, Ernst said.

“Con artists took advantage of small businesses’ pain during COVID to defraud government programs designed to help hardworking Americans,” Ernst said.

“While we are $36 trillion in debt, we especially cannot afford to leave more than $200 billion floating around, especially in the hands of fraudsters. My Republican colleagues and I are making sure that all resources are available in this fight to get taxpayers’ money back and hold these criminals accountable.”

https://www.zerohedge.com/political/7-charged-americas-biggest-covid-tax-credit-fraud-scheme

Amgen Skids On A Surprise Setback For One Of Its Obesity Drugs

 Amgen (AMGN) stock skidded late Tuesday after the biotech behemoth said the Food and Drug Administration placed one of its obesity treatments on clinical hold.

This means Amgen can't run testing of the drug it calls AMG 513 in patients. The company didn't specify the reason for the clinical hold, only saying "discussions are underway on a path forward to reopen the study."

Amgen stock fell more than 1% in after-hours trading, hitting 283.79.

The disclosure isn't related to Amgen's leading weight-loss drug, MariTide. Amgen says it expects to have the results of a midstage study of MariTide in patients with type 2 diabetes in the latter half of the year. The study will focus on patients living with and without obesity.

Amgen Stock: Guidance Mixed

The most important numbers for Amgen are in its guidance, Mizuho Securities analyst Salim Syed said in a client note.

For the year, Amgen guided to adjusted earnings of $20 to $21.20 per share. The midpoint of the outlook, $20.60, lagged analysts' call for $20.92, according to FactSet. But the middle of Amgen's sales guidance for $34.3 billion to $35.7 billion came in ahead of the Street's call for $34.63 billion.

The fourth quarter, though, represented a beat for Amgen.

Across all products, sales increased 11% to $9.09 billion, beating expectations for $8.88 billion. The company also had 13% growth in adjusted earnings, bringing in $5.31 per share. Analysts called for a lower $5.08 per share.

Amgen's biggest moneymaker, osteoporosis drug Prolia, generated $1.17 billion in sales. Sales rose 5% year over year, but missed forecasts for $1.19 billion. Repatha, on the other hand, generated $606 million in sales, growing 45% and beating expectations for $558 million. Repatha is a cholesterol drug.

Mizuho's Syed kept his neutral rating on Amgen stock.

Shares have run more than 12% after hitting a recent bottom at 257.05 on Jan. 6. Amgen stock is involved in a lengthy consolidation with a buy point at 346.85, according to MarketSurge.

https://www.investors.com/news/technology/amgen-stock-amgen-earnings-q4-2024/

Roche gains label expansion for eye implant Susvimo to treat diabetic macular edema

 Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.

The nod is the second indication for Susvimo, an alternative to regular eye injections that was originally approved to treat wet age-related macular degeneration in October 2021.

Twelve months later, however, Susvimo was pulled because of manufacturing problems with the seal on the port delivery device. By July of last year, Roche had ironed out the issues and earned endorsement from the FDA to put it back on the market. 

Susvimo is the size of a grain of rice and is surgically implanted under the upper eyelid. The device provides a customized formulation of Lucentis (ranibizumab), which needs refilling just twice a year.

“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” Jordan Graff, M.D., a vitreoretinal surgeon at a Barnet Dulaney Perkins Eye Center in Arizona, said in a release.

The approval is based on results from a phase 3 study of more than 600 DME patients, which showed that Susvimo accomplished noninferior improvements in vision compared to monthly doses of Lucentis.

Roche has yet to reveal sales figures for Susvimo. On its first go-round on the market, the treatment had started to gain acceptance from ophthalmologists. A few months before its recall, a Spherix survey revealed that a “large majority” of eye doctors acknowledged the therapy’s “superior duration of response” compared to Regeneron and Bayer’s stalwart Eylea. 

Since then, Roche’s Vabysmo—which was approved in 2022—has taken the market by storm, generating sales of 3.86 billion Swiss francs ($4.3 billion) in 2024, while sales of Eylea have fallen to $5.9 billion after peaking at $6.3 billion in 2022.

As for Susvimo, Roche’s pharma chief Teresa Graham said on an earnings call last week that approximately 100 implants were completed in 2024.

“In this stage of the launch, it’s all about getting new ophthalmologists exposure to Susvimo and trained on how to perform the implant and refill exchange procedures,” Graham added. “This is very much a story of going slow to ultimately go fast.”

DME affects approximately 29 million adults in the world, including 750,000 people in the U.S., according to Roche. It occurs when damaged blood vessels in the retina leak into and cause swelling in the macula, which is the central area of the retina responsible for the sharp vision needed for reading and driving. 

https://www.fiercepharma.com/pharma/roche-gains-label-expansion-eye-implant-susvimo-treat-diabetic-macular-edema

Nissan and Honda may call off merger talks, Asahi says

 Japanese automakers Honda and Nissan may call off merger talks, the Asahi Shimbun newspaper reported on Wednesday, citing multiple sources, a move that would raise questions about the next steps for hard-hit Nissan.

The boards of both manufacturers will meet separately in the near future to discuss potentially calling off the merger talks, the newspaper said. For Honda, the talks were not progressing as the bigger automaker had hoped, the Asahi said.

Honda had sounded out Nissan about becoming a subsidiary, an idea that Nissan had strongly opposed, the Asahi said. Public broadcaster NHK had previously reported that Honda had sounded out Nissan about becoming a subsidiary.

A Honda spokesperson was not immediately available outside of normal working hours.

A Nissan spokesperson said that discussions were ongoing between the companies and that there would be an announcement after their finalised their direction in mid-February, as previously announced.

https://finance.yahoo.com/news/nissan-honda-may-call-off-220622122.html

USAID Panic Mode: Gates On MSM Bashes Musk's DOGE, Fear-Mongers on Next Pandemic

 Globalist billionaire Bill Gates made the rounds on far-left corporate media outlets on Tuesday morning, criticizing Elon Musk's DOGE to fold USAID into the State Department—a move that would place Secretary of State Marco Rubio as the agency's Acting Administrator. Gates has panicked, and making the rounds on MSM shows just that because he knows that USAID's funding days for his nonprofit empire might be numbered, as Rubio will apply maximum oversight into grant distributions.

Gates appeared on NBC's Today Show, telling the host that Musk "doesn't appreciate the phenomenal work at USAID." He continued, "It's not partisan work."

However, according to a DailyWire report, 97% of the political contributions from USAID workers went to the Democratic Party. That's a good one, Bill. 

Gates then moved on to his next media stop, appearing on The View, a roundtable of leftist conspiracy theorists. Someone might want to remind Gates' PR team that his credibility (or w/e is left of it) takes a hit by appearing on the daytime show.

He then went into full-blown fear-mongering mode about pandemics and how the next one is nearing.

Gates said something very strange: how the last "pandemic was fairly predictable." 

Why is that Bill? Is it because USAID funded Covid?

"I'm worried about this USAID stuff - my foundation partners with USAID on nutrition and vaccines - there are incredible people at the agency, and they're not 'worms,'" the billionaire said, adding if the USAID funding is not restored: "You could have millions of deaths." 

The Association of American Physicians & Surgeons pointed out on X that Gates' GAVI Alliance was "one of the top recipients of USAID grants in 2024." 

And this. 

Talk about being desperate... 

https://www.zerohedge.com/political/usaid-panic-mode-bill-gates-goes-msm-bashes-musks-doge-fear-mongers-about-next-pandemic