there is a clinical trial called the tame trial that is I think pretty much funded now and maybe getting underway soon the tame trial which is an important trial is going to try to ask this question prospectively and through random assignment
The headline is broadly defensible, but the qualifications matter. Effect sizes vary by population, the strongest claims rest on shorter trials, and credible voices push back on how it's typically framed.
there is a clinical trial called the tame trial that is I think pretty much funded now and maybe getting underway soon the tame trial which is an important trial is going to try to ask this question prospectively and through random assignment
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if the tame study which should answer this question more definitively right this is taking a group of non-diabetics and randomizing them to Placebo versus metformin and studying for specific disease outcomes if the tame study ends up demonstrating that there is a zero protective benefit of Metformin I'll reconsider everything
Targeting Aging with Metformin (TAME) Trial - https://t.co/N1TtQODeBz
the other thing about the tame trial though is it's not being done in healthy elderly people right the people that they're enrolling have to have at least one age-related disease and it can't be diabetes yeah so even that is really not the gold standard study that we'd all like to see
so you could be in remission but you can't have active cancer yes you secondary prevention or primary you could have cardiovascular disease you know in the past if you're if you're okay now you could have mild cognitive impairment in low speed walk will be a criteria so in other words we don't want people like in my study who will become centenarians because we're wasting we're wasting time on them we want people who we know are kind of in the midst of aging and we know that it's never too late to target aging and that's wait so 65 years and up
he also is leading the effort to test metformin in a prospective clinical trial for non diabetics with respect to aging and this is referred to as the tame trial
if tame is done correctly it's really not going to be weighted towards people with diabetes it's going to be looking at people without diabetes and asking the question can this extend life indirectly via mid the onset of chronic disease
i don't think there's a regulatory appetite to even do what what what would be necessary because we have the regulatory appetite to say you take an individual who is either at very high risk for a disease or already has said disease and we will go ahead and accept the risk of a clinical trial to assess it but by definition if you truly want to understand how geroprotective metformin or rapamycin or canagaflazzin or pick your favorite molecule is you really need to be testing it in people before they have a disease
so the tame trial is a specific example of one strategy which is to take people who are already have one age-related disease and ask whether your intervention metformin in this case can delay the onset of of the second age-related disease it's a comorbidity trial
the limitation of that approach is it's not a true healthy aging study right it's not taking people who are who are of normal health status for their age and asking whether the intervention can improve or extend the healthy period of life right
and really tame is not about it's not that we they were not studies for each one of the diseases but there is no studies to be agnostic of the diseases okay we we don't care look we're targeting aging we don't care what disease you have and we don't care which disease you're going to take to get if you're obese and your mother's diabetes you're going to get diabetic necks we have to think in general science that aging is going to drive your next disease yeah and therefore it's the cluster that is going to to count and we're counting the clusters
but i also worry that it won't fully answer the question for our patient population because the tame patient population is not a very healthy population by definition if they can't walk a certain speed they're 65 to 80 years old you're basically selecting people who we expect to have a bad outcome in five years
and really tame is not about it's not that we they were not studies for each one of the diseases but there was no studies to be agnostic of the diseases okay we we don't care look we're targeting aging we don't care what disease you have and we don't care which disease you're going to take to get if you're obese and your mother's diabetes you're going to get diabetic necks we have to thinks in general science that aging is going to drive your next disease yeah and therefore it's the cluster that is going to to count and we're counting the clusters
there is a clinical trial called the tame trial that is I think pretty much funded now and maybe getting underway soon the tame trial which is an important trial is going to try to ask this question prospectively and through random assignment so so this is the targeting aging with metformin trial
if the tame study which should answer this question more definitively right this is taking a group of non-diabetics and randomizing them to Placebo versus metformin and studying for specific disease outcomes if the tame study ends up demonstrating that there is a zero protective benefit of Metformin I'll reconsider everything
tame could be successful independent of whether met foran is effective at slowing biological aging