Dr. Sarah Hallberg – Type 2 Diabetes Reversal

Dr. Sarah Hallberg – Type 2 Diabetes Reversal

November 5, 2019 27 By William Morgan


– So, I’m here to talk
about my favorite subject,
besides my kids,
and that is diabetes reversal.
First, my disclosures.
And the problem.
I know in this audience here,
people are well aware of this,
but we are in the midst
of a terrible epidemic.
So the last time this was
published in a major journal
was in GEMA, looking at 2012 data.
This was published in 2015.
And over 50% of adults in this country
have diabetes or prediabetes.
I mean, it’s really striking.
And the consequence of this is
we can’t afford this anymore, okay?
Of course, the primary consequence
is people’s quality of life,
their length of life is
being really impacted.
But when we look at what is
really going to drive change,
unfortunately, we all know money talks.
And take a look at what has
happened just over six years.
I mean, we cannot afford
to allow this disease
to continue to spiral out of control.
And here is the bottom line,
type 2 diabetes is reversible.
And, you know, for
everyone in this audience,
this fact that type 2
diabetes is reversible
is everyone’s responsibility.
So for those people who
are health care providers,
it is all of your responsibility
to let your patients know this.
For people who are not
health care providers
in the audience,
it’s your responsibility
to let your friends,
your coworker, your
family members understand
that they are not trapped in
an irreversible condition.
They have their own options
on how to take care of their disease.
And they can back out of where they start.
All right.
Okay, so, there are, actually,
three clinically proven ways
to reverse diabetes.
Bariatric surgery, the
literature is quite robust.
I mean, we do get reversal,
and we get prolonged
reversal in many cases.
A very low calorie diet
has also been shown
to reverse type 2 diabetes.
And a low-carbohydrate diet.
Now, I bet no one will
be really surprised,
especially at a conference
that has low-carbohydrate
in its name that I’m gonna
focus on the third one.
But it’s really important to understand
that there’s not just one option.
And that is because
patients have a choice.
All right, so, what does not have evidence
of diabetes reversal?
Sorry, this looks like
it smudged together.
And that is the standard of care.
So a study at Kaiser Permanente,
a really large study,
looks at what happens.
What is the amount of
diabetes remission that occurs
following the standard of care?
And it doesn’t, okay?
So what doesn’t work?
We have three methods that work,
one doesn’t, yet we’re constantly talking
and practicing the one that has failed us.
It doesn’t make any sense.
So, focusing now on low carbohydrate.
So, just really quickly here,
why does carbohydrate restriction work?
Because we know it does,
but what’s the physiology behind it?
And, again, it’s that
different macronutrients
produce different glucose
and insulin responses.
And when we remember,
what is the problem with type 2 diabetes?
The problem with type 2 diabetes
is elevated blood sugars, right?
But even before the blood
sugars became elevated,
the pre-problem, if you will,
is elevated insulin levels.
And it’s just so important
and really so simplistic
to understand that our
three food macronutrients
create very different elevations
in both glucose and insulin.
Carbohydrates cause them both to go up.
And it is really important,
really important for
everyone to understand,
not just the people in this room,
that fat does not cause a
glucose and insulin response.
And so if we want to instruct our patients
to eat something that,
actually, will control
the root cause of their disease,
and not just Band-Aid it
as we do with more and
more and more medications,
we have to instruct them to eat
what scientifically makes sense.
Everyone is an individual,
and personalization is
key to sustainability.
But although everyone
has individual quirks
in their own physiology,
what we see here as far as
their responses to macronutrient
are just generalized to humans,
to, really, mammals.
Carbohydrates will cause the
glucose and insulin to go up,
and fat is flat.
So fat must be a part of
science-based recommendations
for anyone who has type 2 diabetes.
So, let’s talk about healthy carbs
because our guidelines,
again, that have failed us
are full of recommendations
for healthy carbs, right?
Well, it’s okay, it’s a healthy carb.
You know, I’m not eating white rice,
I’m eating a really healthy carb.
It’s brown rice.
So a cup of brown rice with 45
grams of carbohydrates in it
is gonna cause two really
different responses
in individuals depending
on if they have a high
or a low carbohydrate tolerance.
And, clearly, when we’re
talking about type 2 diabetes,
we’re talking about the person in red,
the person who has a very
low carbohydrate tolerance.
So ingesting these healthy carbohydrates
are going to cause an
excessive insulin response.
And, of course, we’ll go back to,
why are patients with type 2
diabetes generally overweight
and often morbidly obese?
Because these high levels of insulin,
insulin being our fat storage
hormone, cause problems.
And what do we do?
What do we all do?
We blame the patient, right?
They’re not following our instruction.
But we gotta go back and look
at this simple physiology.
Wait, we really set this
person up for failure.
So, again, this is from
the American Diabetes
Association guidelines.
The total amount of carbohydrate eaten
is the primary predictor
of glycemic response.
Okay, so let’s take a
look at one of patients
that I saw very recently.
I pulled this CGM data just this weekend.
So his starting insulin dose
was 210 units a day, which,
if anyone who is seeing
patients with type 2 diabetes,
that’s what?
Pretty typical, that’s pretty typical.
That is not like a patient who
comes in once in a blue moon.
That’s, you know, the patient
at nine o’clock on Wednesday.
And his starting A1C was 11.3.
So this is three years into a
low-carbohydrate, ketogenic diet.
And this is his CGM reading.
Insulin dose today, zero units.
He’s still on 2,000 units of metformin.
And his last A1C was 6.1.
And I’m gonna predict
from this glucose curve,
again, that I just pulled.
Oh, actually, no, this
is an old one, I’m sorry.
This is from April.
His last A1C was 6.1, which
was about four months ago.
So pretty soon after this glucose curve.
But you can see what happens
when you remove the carbohydrates.
So this guy had consistent ketones
and a flat curve now.
And I wanna stay on this for just a minute
because I really feel that the
ability for us to give CGMs,
the continuous glucose monitors,
to our patients with type 2 diabetes
is going to be a game changer.
Because when they can
actually look at this
and see this happening, and go,
“Oh, my goodness, “I can’t eat this,”
you know, they’re gonna
wind up pleasing ourselves.
And what we’re gonna get there
is another facet of
support for these people,
which is really exciting.
Because when I throw a
CGM monitor on someone,
I am just super excited as
to watch what’s gonna happen.
Because I’ll tell you,
even in the patients
who we’ve been working with
for a long period of time,
once they have access to
that data in their hand,
like the real time, and
they can see the curves,
not just these simple points,
I mean, it makes all the
difference in the world.
Okay, so, many of you may have heard
the study that came out recently, right?
And for people in this room,
I bet a lot of you had the
same response to it as me.
Duh.
Okay, so, this was picked
up by the media though
and flashed everywhere.
Oh, my goodness, even people who are well,
who don’t have insulin resistance
are having these daytime surges
when we put CGMs on them, right?
So this is gonna, again, really help push
carbohydrate restriction further.
Because what we’re gonna be seeing,
which we have not been
talking about in past, is
this is a problem with everyone.
So, since I have a CGM and
I wear it all the time,
I decided to do a little experiment.
This is me deciding to sit down
and have watermelon with
my kids in the morning.
This is a healthy carb, right?
Now, I have no diabetes, I
have no insulin resistance.
My triglyceride:HDL
ratio is well below one.
And my goal, the blue bar there,
is set to 70 to 100, okay?
This spike, it was 170.
170.
And I get asked a lot, like,
“Well, how much were you actually eating?”
I’m like, “Like not much.
“Like, I sat down and had a bowl
“of watermelon with my kids.”
This is me.
This is a problem.
So this was just last week.
I was so bothered by this
that my new plan is I’m gonna come home
and I’m gonna slap in a CGM on
each of my kids for 10 days.
(audience laughs)
My kids are just gonna
roll their eyes and go,
“Oh, my God, my crazy mother again.”
But I’m like, I wanna
know what’s happening.
I mean, we have low-carb kids,
but I don’t restrict fruit.
And now I’m like, man, do we
need to restrict some fruit?
I don’t know, but this is
really bothersome to me.
Okay, so, how about this?
When we talk in the general public,
away from this type of audience,
one of the questions we always have is
there’s not enough evidence, right?
That, you know, we have
to go with the guidelines
because the guidelines are
where all the evidence is.
They’re evidence-based.
So if you wanna come
up with this new idea,
you just have to have much evidence
to support us changing our ways.
And quite frankly right
now, it’s not there.
Anybody heard that before?
Anybody had that argument?
There’s not enough evidence.
Okay, so let’s take a look at this.
So looking at low carbohydrate
intervention as a treatment
for type 2 diabetes.
There are 20 randomized control trials,
five meta-analysis, and
10 other published trials,
all supporting carbohydrate restriction
for diabetes treatment.
Now, we all know that as a general rule,
low carbohydrate intervention
is not recommended
by the American Diabetes
Association guidelines.
I mean, the last iteration they said,
“Well, maybe for three months or so.”
Like, maybe we could do it short-term,
but you can’t do it for long-term.
So what do they recommend?
The eating patterns that they recommend
are the DASH diet, Mediterranean
diet, and plant-based.
So let’s see how low carbohydrate compares
to all the evidence of the recommended
evidence-based eating patterns.
There it is.
So, here, the white blue,
is randomized control
trials plus meta-analysis.
And then when we add in
other clinical trials,
here’s how low-carb stacks up.
And I would love, take a picture
of this. (audience laughs)
And show it to anybody who tells you
that there’s no evidence.
And the thing is, I’m gonna be working on
more and more graphs of this
because the other thing was,
“Well, the studies weren’t long enough.”
Actually, overall, taken together,
the studies on low carbohydrate
had more people and were longer.
And there’s just more of them in general.
So it’s just not true.
Okay, so now I wanna go back
to talking about evidence
and spend some time talking
about our ongoing study
at Indiana University Health.
So this was initially two year,
and we have increased the time
of the study to five years.
Non-randomized prospective
controlled study.
And I’m gonna come back in a little while
to talk a bit more about study design.
But we recruited 465 patients.
And in our active intervention
arm, there are 378 of them,
of which 262 had type 2 diabetes,
and the remaining 116 have prediabetes.
The usual care arm were patient recruited
from the same community,
same, all at IU Health,
but they were being given
nutrition instruction
by the diabetes educators.
You can see here that the mean (mumbles)
of our patients was quite high.
So these were not cherry-picked patients.
And the other really important
thing about this trial
at baseline is we were
recruiting all commerce,
meaning, we weren’t putting
restrictions on insulin
or length of time with the diabetes.
In fact, if you see here the mean years
that people had type 2
diabetes was really long.
These were really sick people.
If you compare that mean
years with type 2 diabetes
to other studies, including
other reversal studies,
you see that our length
of years with diabetes
is significantly longer.
Once again, not cherry-picked people.
So our primary outcome was body weight,
metabolic syndrome criteria,
and type 2 diabetes status.
Secondary outcomes, we
looked at a number of things,
and we also still have banked samples
that we’re gonna be doing
a lot of fun stuff with.
So what happened at a year?
A1C reduced, and it reduced significantly.
We went from a starting average A1C of 7.5
to 6.2 at a year.
And a couple really important
points on this graph,
which is just how fast
this improvement occurs.
And the reason that that is so important
is because it motivates patients.
We have to remember at every single graph
that any of us put up,
there’s all these patients
that make up those graphs.
And they are all important.
And for each of those
people as an individual,
they wanna see results that are
actually meaningful quickly.
They wanna be given
instruction that works,
and they wanna be able to see
the improvement very quickly,
including, you know, one of
my favorite things to
hear from a patient is
when they start at the clinic
and then a month later they say,
“Oh, my gosh, I can’t believe it.
“The very next time I
went to the pharmacy,
“my cost was reduced already.”
So this quick drop is important
for each of those individual data points.
But, again, we don’t see the
drop and then a rebound, right?
We see a continual decline
out to a full year.
And if we look at the gray bar above,
this is the usual care.
So remember what type 2
diabetes has been called
by many organizations,
including the American
Diabetes Association.
It is a chronic and progressive disease.
And I agree with that statement
if we’re using standard of care.
That’s what happens over time.
We slowly get worse.
So, again, it’s not just not
the A1C that was improving,
it was the medications that
were also being reduced.
57% of prescriptions for
diabetes were discontinued.
And if we look here, like sulfonylureas,
which I think for any of you
who work with these patients,
like this is the first one
to get people off of, right?
I mean, it’s taxing the pancreas.
They’re just, in my opinion, nightmares.
But, unfortunately, in general practices
we turn to them all too
often because they’re cheap.
We were to able to
remove all sulfonylureas.
And for insulin,
94% of the patients who
began the trial on insulin
had the insulin decreased
or totally eliminated.
And if you can see, the total elimination
was really significant.
But, you know, this goes across to
other classes of medications, too.
And the one you see not
that much of a change in it,
the N there is metformin
because metformin has indications
outside of type 2 diabetes.
And no matter how wonderful we
make their glycemic control,
these are people who had type 2 diabetes,
and they are at risk.
And so I really feel like metformin is one
that I have a risk-benefit discussion
with the patients about.
And I let them choose.
I say, “We have reasons to believe
“that this may be
helpful in the long run.”
And some patients are like,
“Great, I can stay on it.
“it’s not bothering me, it’s super cheap.”
And other patients are
absolutely, “I want off of it.”
So I let the patients choose.
And then you see that we
did add some GLP-1 agonist.
And the reason, clinically, that I do this
is it’s a great bridge to
get people off of insulin.
Because we know those
high levels of insulin
are gonna impede their weight loss,
and it also cause risks
of hypoglycemic events.
We really wanna get people off the insulin
as quickly as possible.
And that’s kinda my favorite way to do it,
is we switch them just
to another injectable,
and then we can get them
off of those over time, too.
But, really, we’ve reduced
their hypoglycemic risk quickly.
All right, so not only do
patients get off of them,
but, of course, this
doesn’t surprise anybody,
with that much reduction in medications,
we’re saving money as well.
So medication reduction at a year was 46%.
Again, remember, this is
just medication reduction,
this doesn’t yet take into account
all the other cost associated
that make up the over
$300 billion a year now,
such as reduced productivity,
days off of work,
hospital costs, all those things.
And do patients stay engaged, right?
Because in addition to the argument
that there’s no evidence for it,
the second biggest argument
I get is people can’t do it.
And so 83% at a year.
Like, when we look at prescriptions
that we write for our patients,
there’s no way at a year 83% of them
are still taking those prescriptions.
So this people adhered
to better than a pill.
Don’t tell me that’s not sustainable.
Okay, so, our goal was not weight loss.
Straight up, we told patients that’s not.
If you do it, great,
that’s a wonderful benefit.
But despite the fact that our
focus was not on weight loss,
people lost a lot of weight.
And as you see, we do not
have the six-month uptick
that you see in most
weight loss trials, right?
People lose weight for
three to six months,
and then we go up again.
But, here, we are all
the way out to a year
and we aren’t continuing
to lose on average,
but we’re flattening out
at a much lower rate.
So in addition to publishing our
one year diabetes-related
results, we also published
a one year cardiovascular
risk paper as well.
And this is my favorite graph
probably from the whole trial so far.
And it looks at all these
markers of cardiovascular risk,
comparing our intervention to
the control patients which are in gray.
So we can see here, I mean,
really, our intervention
patients rocked it (chuckles)
as far as cardiovascular risk goes.
What is the one, one exception
where it got a little bit worse?
If you notice here, LDL-C
did go up a little bit.
It went up by about 10%,
which many would consider very significant
as far as increasing cardiovascular risk
until you take a look at
their apo B and LDL-P.
And Ron already talked
very nicely about this.
And that in these patients,
they can have a normal LDL-C
or a slightly elevated LDL-C,
yet their LDL-P and apo B can be sky-high.
But that’s not what we were seeing here.
We were seeing the
increase only in the LDL-C.
Their apo B and their LDL-P,
actually, went down slightly.
Wasn’t statistically significant.
But the point is, we weren’t
increasing this risk.
So, really, we had all these improvements.
Yes, you can reverse your type 2 diabetes
and improve all these other risk factors,
and not be making other things worse.
So that’s really exciting.
And so how about their 10-year risk score?
We took a look at that, too.
And, again, what happened
with our intervention patients
compared to usual care?
It’s more of the same thing.
And so liver function,
you know, another big problem
and another big cost
associated with type 2 diabetes
is all the problems people get
because of fatty liver disease.
And so here we see a
significant improvement
in liver function as well.
So kinda to take a look,
big picture overall,
really, 60% of the patients
in the intervention arm at a year
reversed their type 2 diabetes,
which means they had a glycemic control
under the diabetes threshold
and we’re off all
diabetes-related medications
with the possible exception of metformin
for the reasons I discussed before.
And, again, medication reduced
while the improvement in A1C,
weight loss, and improvement
in cardiovascular risk factors.
I mean, what’s not to
love from this, right?
So here’s a question.
And I know I’m running short on time,
but I wanna make sure that I cover this.
Did they actually eat
what we told them to?
Because in any nutrition intervention,
we’re giving them instructions
that’s all well and good.
But the question is, did they do it?
And how have we tracked this?
In all prior nutrition interventions,
we rely on food records.
What do we all know about food records?
They stink.
They stink, they’re not good,
they’re fraught with error.
And it really makes,
I believe this is actually
one of the reasons
that nutrition science is so contentious.
Because no matter what someone publishes,
someone could come up and say,
“Oh, they didn’t really do it.
“Your food record method stunk.”
We can’t say things
definitively until now.
So did they actually eat a ketogenic diet?
They did.
Because we had a biomarker to follow.
We followed beta-hydroxybutyrate.
So our study is really unusual.
We didn’t use food journals.
Our patients didn’t have to
write down everything
that they were eating.
We used this as a marker.
And, yes, they were doing it.
So I think not only is this,
in and of itself, important
for this particular study,
it also brings us to a
question of study design.
Because we did not do a
randomized control trial.
And, you know, that’s often a criticism.
Oh, my goodness, everything needs to be
randomized control trial.
That’s the gold standard.
And it’s the gold standard,
and makes really good
sense for drug studies.
But the problem with nutrition studies
is that the people have
to be invested in it,
especially if you’re planning
on doing a long-term study.
So if you all of a sudden
take a group of people who
let’s just say have been following
a low-carb, high-fat diet,
and you tell them all,
“Well, we’re gonna put you in a study,
“and half of you are gonna have
to be vegan for five years.”
Or, you know, or anything.
That really significant
change to their diet.
And they’re not invested in it.
They don’t believe in that.
It’s not going to work
because you’re not gonna
get the compliance.
So you want people who are invested in it.
And this goes back to my
argument of patient choice.
Patients need to choose the intervention
that they want to follow.
And I think that that’s really important.
So the idea of randomizing
that is a little tricky.
So how do you support
sustainable behavior change?
And support from many angles is critical.
So the patients in our study,
actually, had a ton of different
ways of getting support.
They tracked their biomarkers
and we’re able to follow them.
They all had a health coach,
and they all had a
physician following them.
In the trial, it was me.
And they were able to coach
based on those biomarkers
to help people and really
make it personalized for them.
They had a patient community,
and they also had a ton of resources
that they had access to.
So the other thing you need to really
have sustainable changes,
and you have to give
people advice that works.
And, whoops.
And, again, we know from
the graph how quickly
not only this works and works
for a long period of time,
but, you know, people are excited
to eat this kind of food, too.
The idea that people can’t stick with it
because it’s boring
and doesn’t tastes good
is just not the case.
Oops, sorry.
So I just wanna end with this.
Reminding everyone that there are three
clinically proven ways to
reverse type 2 diabetes.
We need to be talking about this.
We need to let patients know
that they once again have control.
Because telling a patient
who is diagnosed with type 2 diabetes
that they are stuck, that it
is progressive and reversible,
and there’s nothing to do about it
takes the control away from that patient.
And when you can tell them,
“There’s something you can do about it,
“you can reverse out of this,
“and here are the ways.”
And the most important thing is then
to give patients the choice.
And I clearly believe that most patients,
when given the choice,
are going to choose a
carbohydrate-restricted plan,
but if they choose one of
the other ones, that’s fine.
It’s not gonna be ever a
one-size-fits-all for each patient.
We have to respect that always.
But the problem is that patients
are not given the choice right now, right?
They’re not given the choice
because this is not being discussed.
So I’ll go back to what I
said at the very beginning.
It’s everybody’s
responsibility in this room
to make sure that all people
with type 2 diabetes know
that it does not have to be
a chronic and progressive disease.
Give them the power back.
Give them the choice.
Thank you.
(audience applauds)