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New Drug Delays Onset of Type 1 Diabetes

In November, 2022, the FDA approved the first drug that can delay onset of type 1 diabetes. The FDA press release won’t make much sense unless you know that type 1 diabetes has several stages. From Diabetes Care:

Stage 2, like stage 1, includes individuals with two or more islet autoantibodies but whose disease has now progressed to the development of glucose intolerance, or dysglycemia, from loss of functional β-cell mass. The 5-year risk of symptomatic disease at this stage is approximately 75%, and the lifetime risk approaches 100%.

Stage 3 represents manifestations of the typical clinical symptoms and signs of diabetes, which may include polyuria, polydipsia, weight loss, fatigue, diabetic ketoacidosis (DKA), and others.

What follows is the verbatim FDA press release:

Today, the U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. 

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.” 

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People with a type 1 diabetes diagnosis have increased glucose that requires insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent, brother or sister with type 1 diabetes, although most patients with type 1 diabetes do not have a family history.

Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days. 

Tzield’s safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients randomly received Tzield or a placebo once daily via intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis. The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes. 

The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield. 

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Dear Men: Heed the Hot Crazy Matrix

Yes, there are exceptions…

Steve Parker, M.D.

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One More Cure for Hiccups

I’ve written previously about how Paul Ingraham helped cure my patello-femoral pain syndrome.

More recently, Paul looked into hiccup cures because his father had an intractable case. What finally worked for dad? Breathing into a plastic bag.

Boosting blood CO2 (hypercapnia) by breathing in a PLASTIC bag. This one is quite plausible and is easy and safe to try. Hypercapnia definitely affects some kinds of hiccups. The story (from a smart source, a good “friend of PainSci”): “There’s an even easier way out of hiccups — at zero cost. Learned it from my uncle, who studied medicine in Brazil in the 50s. Anesthetized patients with hiccups were a pain, so they needed to get rid of it ASAP. Method: breathing in a PLASTIC bag, small enough for you to get to hypercapnia (get higher blood levels of CO2). You have to hold the bag REALLY tight around nose and mouth to prevent air from escaping, and if you have troubles with dizziness, it’s advisable to sit down for it. As soon as it gets uncomfortable, mostly after 4-6 breaths, you can stop, the hiccup will be gone. I don’t know what this does to the phrenic nerve, but it works 100%.”

Safety Note: Obviously there could be some danger with this method. If he’d had low O2 or was struggling for breath, we likely wouldn’t have dared. (On the other hand, if he’d been in that state, he would’ve been at the hospital.) But he was supervised, with no possibility of getting stuck, and a matter of only just a few breaths. Perhaps there was still some risk… but I think not treating those hiccups was also a risk.

I’ve never tried that method for my hiccups. My personal favorite home remedy is “drinking from the far side of the glass.” AKA, drinking water upside down. Watch this video of a good ol’ boy demonstrating the technique although I would aim for drinking at least 6-8 fl oz of water before quitting. Don’t ask me how it works; it may have something to do with the soft palate or diaphragm.

Steve Parker, M.D.

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Should You Eat With Your Hands and Eschew Cutlery?

“Me Grok”

DailyMail has an interesting article that promotes eating with your hands instead of forks, knives, and spoons. After all, caveman Grok didn’t have eating utensils.

Those who are a stickler for etiquette should look away now.

That’s because we’ve all been dining the wrong way and should be eating with our hands, according to a psychologist.

Professor Charles Spence, from the University of Oxford, said giving up cutlery is the secret to enjoying food.

He says eating with our hands can ‘heighten the dining experience’ – even for meals like pasta and messy curries.

The professor also claims that hand-feeding improves food flavor and texture while having myriad health benefits.

Steve Parker, M.D.

PS: I rarely use “eschew” in conversation because few folks don’t know what it means. In general, I eschew obfuscation.

h/t Splendid Isolation

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Black Tea Cuts Risk of Death by 10%

according to an article at Annals of Internal Medicine. The study was done in a U.K. population over decade of observation. The 10% or greater reduction in all-cause mortality was seen at a habitual consumption level of two or more cups of black tea daily. Most prior similar studies I’ve seen focus on green tea.

Photo by Lisa Fotios on Pexels.com

Steve Parker, M.D.

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Prevent Nearsightedness Complications With Early Treatment

Steve Parker MD, paleobetic diet,
Should have spent more time outdoors

Myopia, aka nearsightedness, is extremely common and can start in childhood or young adults. Over time it can lead to early-onset cataract, retinal detachment, and glaucoma. MedPageToday has an eye-opening article on treatments that can prevent myopia progression and complications. For example:

Common evidence-based treatments that offer both statistically significant and clinically meaningful efficacies include daytime multifocal soft contact lenses (MFSCL), overnight orthokeratology (ortho-k), and topical low dose atropine (LDA). Novel spectacle lenses also showed a promising myopia-inhibiting effect, albeit with limited availability in U.S. at the current moment. On average, these options slow myopia progression by 30-70% compared to conventional single vision glasses or contacts. With properly selected early interventions, not only the development of myopia stabilizes at younger ages, the endpoint of the progression is also much lower, resulting in significantly lower risk of complications. Furthermore, with lower level of myopia at stabilization, many myopic patients could be good candidates for refractive surgery with given corneal thickness.

I get the impression from the article than treatments need to be started in childhood.

Steve Parker, M.D.

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Does Poor Posture Cause Back Pain?

Photo by Budgeron Bach on Pexels.com

No, according to these three credentialed experts at The Conversation. A snippet:

There is a common belief that “good” posture is important to protect the spine from damage, as well as prevent and treat back pain. Good posture is commonly defined as sitting “upright”, standing “tall and aligned”, and lifting with a squat technique and “straight back”. 

Conversely, “slump” sitting, “slouch” standing and lifting with a “round back” or stooped posture are frequently warned against. This view is widely held by people with and without back pain, as well as clinicians in both occupational health and primary care settings

Surprisingly, there is a lack of evidence for a strong relationship between “good” posture and back pain. Perceptions of “good” posture originate from a combination of social desirability and unfounded presumptions.

Click for more of my blog posts on low back pain.

Steve Parker, M.D.

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Ultra-Processed Foods May Impair Cognition in Elderly

Processed or ultra-processed?

An article earlier this year in the European Journal of Nutrition reported that high consumption of ultra-processed foods is linked to worse-than-average performance on one particular test of cognitive function in older U.S. adults (60+ years-old) who did not have chronic diseases such as diabetes or cardiovascular disease. The particular test was “Animal Fluency.” Never heard of it? Me either. Keep reading.

The study included 2,700 participants, average age 69. Participants were asked to recall what they ate in the prior 24 hours. Foods were “classified according to NOVA, a food classification based on the extent and purpose of industrial food processing, into four mutually exclusive groups: (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, and (4) UPFs [ultra-processed foods].”

Ultra-processed foods? “…most foods described as “Frozen meals” or “Lunchables”, as well as some items described as consumed in “Restaurant fast food/pizza” or acquired at a “Vending machine” were classified as UPFs.” Furthermore, the authors write in the introduction that “UPFs, according to NOVA classification system, are industrial formulations of processed food substances (oils, fats, sugars, starch, and protein isolates) that contain little or no whole food and typically include flavourings, colourings, emulsifiers, and other cosmetic additives. UPFs are becoming dominant in diets globally and are replacing traditional diets based on unprocessed and minimally processed foods.

Of the entire study population at hand, UPFs were about half of all calories consumed but ranged from 30 to 70%.

“Cognitive performance was assessed using the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD), Word Learning test, Animal Fluency test, and the Digit Symbol Substitution test (DSST).”

The Animal Fluency test “evaluates categorical verbal fluency (executive function).” “For the Animal Fluency test, the participant is requested to name as many animals as possible within a 60-s [60 seconds, I assume] time period. Each animal corresponds to 1 point and the result is presented as the total sum of points.”

Mr Ed, the fluent horse (You won’t get this if under 63)

The test subjects were given two other tests of cognitive function but the investigators found no differences in performance based on ultra-processed food consumption. Here are these other two tests:

The two parts of the CERAD Word Learning test consist of (1) three consecutive learning trials, where the participant is requested to recall a list of ten unrelated words immediately after their presentation. Each word corresponds to one point, and the result is presented as a total score across the three trials (range 0–30); and (2) a delayed word recall test, performed after the two other cognitive tests. The result ranges from 0 to 10. … For the DSST, the participant is presented a single sheet of paper where they are asked to match a list of nine symbols to numbers according to a key located on the top of the page. The task had 133 numbers and the participant had 2 min to complete it. The result is shown as the total number of correct matches. For all the tests, higher scores represent better cognitive function. 

The authors conclude: “Consumption of UPF was associated with worse performance in Animal Fluency, a cognitive test that assesses language and executive function in older adults without pre-existing diseases such as CVD [cardiovascular disease] and diabetes, while no associations were observed for those with these conditions. While longitudinal studies are required to provide stronger evidence, these results suggest that decreasing UPF consumption may be a way to mitigate age-associated cognitive decline and reduce the risk of dementia.”

I agree these results aren’t very strong.

Steve Parker, M.D.

h/t Jan at The Low Carb Diabetic blog

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Vitamin Combo Prevents Age-Related Vision Loss

These are the ones I take. In the U.S., your best price may be at Costco or Sam’s Club.

I have a particular interest in preventing age-related macular degeneration (ARMD) since it runs in my family. It’s the leading cause of vision loss in adults over 50.

Photo of the retina at the back of the eyeball

From JAMA Ophthalmology:

Question  What were the long-term findings of Age-Related Eye Disease Study 2 (AREDS2) supplements regarding development of lung cancer or progression to late age-related macular degeneration (AMD)?

Findings  In this epidemiologic follow-up study of the AREDS2 cohort of 3882 participants and 6351 eyes, 10-year follow-up results showed that development of lung cancer nearly doubled in participants assigned to beta carotene among former smokers but not those assigned to lutein/zeaxanthin. Lutein/zeaxanthin was associated with a reduction in the risk of progression to late AMD when compared with beta carotene.

Meaning  These findings suggest that the AREDS2 supplement with lutein/zeaxanthin instead of beta carotene was safe, with no association with developing lung cancer and a potential beneficial association with further reduction in progression to late AMD.

Steve Parker, M.D.

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Mediterranean Diet Likely Just As Healthful For Children As For Adults

Not sure where this is. Leave a comment if you recognize it.

Nearly all studies demonstrating the healthful effects of the Mediterranean diet were done in adults. Here’s one suggesting benefit in children.

Our findings suggest a positive correlation of Mediterranean diet  adherence with health-related quality of life in children and adolescents. However, future research is needed to strengthen the evidence of this relationship.

Source: Adherence to Mediterranean diet associated with health-related quality of life in children and adolescents: a systematic review | BMC Nutrition | Full Text

     Steve Parker, M.D.

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