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toobs1234
(@toobs)
Joined: 6 months ago
Posts: 21
07/06/2020 1:55 pm  
But I have personally seen hard to treat hormone positive breast cancer skin metastases shrivel and die within weeks while on a plain syrosingopine + metformin + loratadine + low carb diet as the only treatment. Unfortunately the low blood pressure and undernourishment side effects became too bad for the patient to take.

Hi gge,

This is really helpful! That's now three human cases I know of. Two positive, one negative. Please share any details you can. Knowledge is king.

Just to be clear, I don't mean to question that metformin/syro can work as a dual therapy...just that it seems from the info we have that it may not work as well if MCT1 is activated. Without having knowledge of MCT1 levels, it seems that adding diflunisal may be a good bet.


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
09/06/2020 5:50 am  
Posted by: @toobs

Please share any details you can

All metastases are bad. One extra bad thing about skin mets is that they affect the patient’s appearance and self-esteem. There is only one good thing about them: you can fairly accurately see when they respond to a treatment faster than with scans or marker tests.

Per Toobs' request, I am posting here approximately the way this patient’s breast cancer syromet treatment went from the best of my recollection. I apologize if I err or don’t have important details that you might need to understand the developments. Unfortunately no cancer marker test or scans were taken immediately before or after the syromet therapies that could allow for a better assessment of their effects. Her response to this treatment was judged mostly by the visual changes in her dermal mets.

She had been on a very low carb vegan diet as an aid to fighting her cancer during endocrine, CDK, and immune therapies for about 2 years. These therapies did not lead her tumors to shrink permanently or to keep her cancer from spreading but they probably slowed their progression.

Her entire area of dermal spread was originally pink to red to burgundy in various tones and was raised above the rest of the breast skin surface about 1/4mm with numerous hard nodules beneath.

She had stopped all conventional treatments a couple months earlier but continued on her diet. She adopted a syromet regimen consisting of 500 mg of Glucophage SR 2 times a day (1 pill at breakfast and another 500 mg pill at dinner for more even blood level) and a gradually increasing syro dosage that started at around 1 mg a day. Her goal was to take 0.1 to 0.2 mg of syro per kg. Caffeine pills were added in increasing doses as the syrosingopine dose rose to successfully counter its growing blood pressure lowering effects. This treatment started showing signs of cancer cell stress at the .09 mg per kilogram dosage.

Some of the dermal spread spots began sinking and leveling with the rest of the skin as the treatment caused a response. These skin spots started changing color towards a very light orange, then tan. However, the response was slow to show and very limited in its extent probably because of the low syro dose and her large tumor burden. I estimate her primary breast tumor was over 200 cc in volume.

She tried to raise her syro dosage but couldn’t tolerate the side effects when syro got to .1 mg per kg level. So after about 7 weeks with the above therapy she added Claritin and stayed at about .095 mg per kg of syro a day. She followed a syromet and Claritin regimen with 500 mg of Glucophage SR 2 times a day (1 pill at breakfast and another 500 mg pill at dinner for more even blood level), 10 mg loratadine (taken in one 5mg half at breakfast and another half at dinner) and about .095 mg per kg of syro a day.

Most of the dermal spread then began sinking and leveling with the rest of the skin as the treatment had a stronger response. The earliest responding skin areas and some new spots continued turning color in a scale that run gradually from very light orange, to tan, to light brown, to darker and darker brown, began contracting in size and forming some dry, dead skin layers on their top surfaces. A few responding areas began turning back towards the color of normal, healthy skin.

The responding areas usually started as tiny spots in various places within the cancerous areas then they slowly spread larger while the patient continued the treatment. No effects were noticed on any healthy skin areas. Changes were noticed only within the cancerous mets.

However, simultaneously a few small new skin metastases started forming. It seems as though there was progression at the same time as regression. I imagine that although her treatment was killing many cancer cells, it was not killing them fast enough.

She had been just about 6 weeks on the syromet+ loratadine therapy and was taking 1000 mg metformin SR, 10 mg loratadine and about .095 mg per kg of syro a day.

Since the patient couldn’t tolerate the side effects of a higher syro dose, she added a totally different (non-conventional) treatment to see if it would further enhance the effects of the syromet. Unfortunately this addition brought new, serious side effects within days and then she stopped both treatments and the diet altogether.

The cancer then resumed its growth and accelerated its spread. All the dermal spread began rising above the skin again and regaining a pink to red color. The areas that had recently turned light orange returned to their original pink or red color as they recovered. However, the areas that had turned dark brown continued dead and formed hard scabs just like the ones that form over a healing wound. Most of these fell off just like wound scabs letting active cancerous skin show below. A few of these dark spots did not fall off and stayed attached for months. I imagine they were necrotic tissues rooted deeper in the nodules and not just on the dermis.

If I remember new details or realize I made a mistake in this narrative I will post it here.


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MajorTom
(@majortom)
Joined: 5 months ago
Posts: 9
09/06/2020 12:06 pm  

Thanks for the very interesting and detailed update. Perhaps the patient could benefit from a topical application. Syrosingopine, loratadine are soluble in DMSO which is skin permeable. If applied directly on the mets, this will presumably require lower doses and will not be diluted as a whole body dose. Of course this is only treating the mets but it may bring some relief.


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Daniel
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09/06/2020 2:11 pm  
Posted by: @gge
Posted by: @toobs

You can, however, dose diflunisal high enough to get effective MCT1 inhibition

Can you please explain why you think the above? Tom seems to doubt that the diflunisal level can ever get high enough to inhibit MCT1 sufficiently as to cause synthetic lethality.

Also, do you have info about the levels diflunisal can reach in tissues, esp. cancer tissues, and whether it accumulates in them so that its concentration level can be much higher than in plasma?

Hi Gge,

Here is Diflunisal showing response many cancer types (bust used intravenously with aspirin) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4997972/

So the answers is: yes, when given intravenously it can reach the tumours in high enough dose to affect them. However, the main activity may not be related to MCT1.

Kind regards,
Daniel


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toobs1234
(@toobs)
Joined: 6 months ago
Posts: 21
09/06/2020 4:05 pm  
Posted by: @gge
Posted by: @toobs

You can, however, dose diflunisal high enough to get effective MCT1 inhibition

Can you please explain why you think the above? Tom seems to doubt that the diflunisal level can ever get high enough to inhibit MCT1 sufficiently as to cause synthetic lethality.

Also, do you have info about the levels diflunisal can reach in tissues, esp. cancer tissues, and whether it accumulates in them so that its concentration level can be much higher than in plasma?

Hi Gge,

Please take a look at the original paper I cited:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6224440/

It shows the impact of Diflunisal on lactate efflux not only alone, but in combination with Metformin and Diclofenac (a MCT1 and MCT4 inhibitor, but like Syrosingopine it's a more effective MCT4 inhibitor). It shows inhibition at physiologically achievable doses.

Some more documentation of Diflunisal as an MCT1 inhibitor:

https://core.ac.uk/download/pdf/48656996.pdf

That paper has the most comprehensive list (and test) of compounds that act as MCT1 inhibitors. It does look at lactate influx, not lactate efflux.

"The inhibitory concentrations of tested NSAIDs (diflunisal, mefenamic acid,
meclofenamic acid, flufenamic acid and tolfenamic acid) are in the range of
physiologically relevant concentrations that are achievable from the oral intake.
For example, the suggested dosage range of diflunisal is 500 mg to 1000 mg daily
for osteoarthritis and rheumatoid arthritis. The peak plasma concentration of
diflunisal achievable from single 500 mg oral dose was 87 ug/mL, while the Ki of
diflunisal is 29.56 uM (equivalent to 7.40 ug/mL). Therefore, a strong inhibition of
NSAIDs on MCT1 is achievable at the relevant plasma concentrations of diflunisal."

a few others...

https://pubmed.ncbi.nlm.nih.gov/16105239/

https://books.google.pt/books?id=Lf4jDwAAQBAJ&pg=PT347&lpg=PT347&dq=%22diflunisal%22+mct1+inhibitor&source=bl&ots=TwFKXE3P7u&sig=ACfU3U0q-6ywcjs_lUuQdRy-QS3YaVJ42w&hl=en&sa=X&ved=2ahUKEwiZmq3j7fTpAhX0BWMBHbAGAYEQ6AEwAnoECAsQAQ#v=onepage&q=%22diflunisal%22%20mct1%20inhibitor&f=false

there are more, but I didn't save them. If you're still not convinced, a quick google search on Diflunisal+MCT1 will yield some more.

 

 


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
09/06/2020 8:45 pm  
Posted by: @majortom

Perhaps the patient could benefit from a topical application. Syrosingopine, loratadine are soluble in DMSO which is skin permeable. If applied directly on the mets, this will presumably require lower doses and will not be diluted as a whole body dose. Of course this is only treating the mets but it may bring some relief.

Thanks for the advise. This patient is now following another therapy and the dermal spread is again been used as a quick. easy marker of effectiveness. Treating it locally might lead it to respond but it would disengage it from the rest of her tumors and thus become no longer representative of their response.


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
13/06/2020 4:28 am  
Posted by: @toobs

The peak plasma concentration of
diflunisal achievable from single 500 mg oral dose was 87 ug/mL, while the Ki of
diflunisal is 29.56 uM (equivalent to 7.40 ug/mL).

Posted by: @toobs

the impact of Diflunisal on lactate efflux not only alone, but in combination with Metformin and Diclofenac

This is a hard question. I just want your best guess. Can you guesstimate what would be a low-side effect dose of diclofenac and diflunisal to add to a 10 mg loratadine, .1 mg per kg of syrosingopine () and 1000 mg of metformin SR per day that might have a reasonable chance to work in a responsive metastatic breast cancer cancer situation like the one I described above?


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
13/06/2020 4:31 am  
Posted by: @jpizzuto

she needs the biopsy.

We have decided to not make any waves

Did you get your results back? If so, is there any good news in them?


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
14/06/2020 2:35 am  

I believe the results are in, but they have not talked to us yet.  They are very short handed, with most of the staff working from home, doing phone consultations.

Imaging was by ultrasound, rather than PET/CT.  The sample was taken from her left side, third rib.  The surgeon said he hoped they got a sample or they would have to try again.  Shirley said they put it under the microscope and said we got what we need. 

She said the procedure was VERY painful and said she will not do it again.  They gave her a local but it wasn't enough.  She was not allowed anything since the previous night, so by the time of the biopsy, it had been 12 hours without her pain pills, 6 hours overdue.

We were at the cancer center a few days ago for her monthly injections of Xgeva, Faslodex, and vitamin B.  She is also taking Verzenio.


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
14/06/2020 4:55 am  
Posted by: @jpizzuto

Imaging was by ultrasound, rather than PET/CT.  The sample was taken from her left side, third rib. 

I guess the sample was from her lung and the ultrasound was to guide the needle to the right spot.

Sorry that she had to endure all that...It is hard enough without the added procedure pain. I hope the results give you info that can help improve her treatment.

Best wishes to both of you!


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Jcancom
(@jcancom)
Joined: 3 years ago
Posts: 439
20/06/2020 3:55 am  

JohnnyP, read your email please!

Best Wishes, J


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
22/06/2020 12:22 am  

@jcancom

I received an email about the 3BP thread.  I can still view it.  Do you have another message for me?


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Jcancom
(@jcancom)
Joined: 3 years ago
Posts: 439
22/06/2020 12:33 am  

JohnnyP, check your inbox, junk, or spam for an email on Thursday June 18th, around 5 PM depending on your time zone.


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
22/06/2020 12:49 am  

@jcancom

OK, I found it.  I'll reply to the email.


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Rolland Coderre
(@rollandcoderre)
Joined: 2 months ago
Posts: 1
25/06/2020 9:23 pm  

Good day,

I'm from Canada.  Can anyone tell me where I can obtain Syrosingopine?

Thank you.


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n/a
 n/a
(@johan)
Joined: 2 years ago
Posts: 509
26/06/2020 5:15 am  

@rollandcoderre

Apotheke Roter Ochsen AG
Vorstadt 50
8200 Schaffhausen
Email: [email protected]
aporo.ch

or China supplier. 


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
18/07/2020 11:06 am  

@gge

We received the PI3K inhibitor, Piqray, today.

I found a couple more videos of Dr. Lewis Cantley.  This one is from 2015, as the trial was in progress:  https://www.youtube.com/watch?v=YsZy6G18Gqs

This one was from 2011, pre-trial:  https://www.youtube.com/watch?v=lJ1x1aSyHSw

Another one I haven't watched yet:  https://www.youtube.com/watch?v=MN9T0VH36Tc


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
18/07/2020 4:03 pm  
This guy is excellent.  In this video from 2016, he tells how his lab goes about bringing a new therapy to the clinic (I have it Q’d up):

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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
18/07/2020 11:05 pm  
Posted by: @jpizzuto

We received the PI3K inhibitor, Piqray, today.

Posted by: @jpizzuto

We were at the cancer center a few days ago for her monthly injections of Xgeva, Faslodex, and vitamin B.  She is also taking Verzenio.

Thanks for the postings, very informative. Piqray should be accompanied by Faslodex in HR+ BC, I imagine Shirley will continue on it.

How did Verzenio go? Is Shirley still on it? I think I read somewhere that Verzenio seems to enhance the effects of Piqray

 


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Jcancom
(@jcancom)
Joined: 3 years ago
Posts: 439
19/07/2020 12:23 am  

GgE, great to see that you are back on forum.

Thank you for continuing posting to the thread over my prolonged absence. One large enhancers that I can see for syrosingopine is a better formulation. There is a substantial treatment barrier with the side effects caused from syrosingopine including low blood pressure etc.. Moving to chitosan or other formulation might overwhelmingly enhance efficacy and safety. Chitosan is a very nice and simple approach to formulating cancer drugs that has been shown to greatly enhance potency. For example with chitosan methylglyoxal (nano-MG) dose was able to be reduced over 100 fold while maintaining a great deal of anti-cancer effect. I would be very interested in seeing a nano-syro or other formulation for syrosingopine.  


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
19/07/2020 2:07 am  

@gge

I watched Cantley's most recent video about the PI3K inhibitor Piqray, just as she was starting Verzenio.  I asked them if we could get it, they said not until Verzenio stops working.

She stopped taking Verzenio after five weeks, due to side effects.

We got the Piqray yesterday.


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
19/07/2020 2:25 am  
Posted by: @jcancom

with chitosan methylglyoxal (nano-MG) dose was able to be reduced over 100 fold while maintaining a great deal of anti-cancer effect. I would be very interested in seeing a nano-syro or other formulation for syrosingopine.  

This would be great. But, will it ever happen?

  


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GgE
 GgE
(@gge)
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19/07/2020 2:26 am  
Posted by: @jpizzuto

She stopped taking Verzenio after five weeks, due to side effects.

Sorry about that.

Posted by: @jpizzuto

We got the Piqray yesterday.

I hope she responds to it and avoids major side effects.


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
19/07/2020 2:35 am  

@gge

She read the list of side effects yesterday, including severe diarrhea, and is putting off starting it as long as she can.

The directions say take with food, but she doesn't eat much.  Most of her nutrition comes from the high fat protein shake I make her.


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Jcancom
(@jcancom)
Joined: 3 years ago
Posts: 439
19/07/2020 3:36 am  

GgE, yes it does seem to take time for things to unfold, though as we have seen life does evolve, though slowly. With a little direction, a collective ethos emerges spontaneously and self-organizning development can occur.

nanosyro should be an inexpensive and simple synth. Chitosan allows treatment to be delivered directly to the cancer cells and then once it arrives the acid in the cancer environment melts the chitosan releases the treatment and is absorbed almost exclusively by the cancer cells. There would then be no systemic side effects.

Hopefully, the researchers might formulate syrosingopine with chitosan to demonstrate the effect in mice. If nanosyro allowed dosing up, then the effect of treatment would likely be profound. Metabolic treatments often seem to be like that. There are incremental steps forward, all the while hinting at significant treatments effects. Metabolics many times can be greatly improved by reformulating etc. Yet, typically with pharma products the preliminary research stage of development produces nearly optimized treatments that are then marketed.   

I am also glad to see that the lactate monitor idea was thought useful to posters on thread. Hopefully others will also take this up and develop it further. Recording lactate in near real time could be a significant step forward for us. If you treat with syromet etc., and can see a proximal temporal response in lactate levels, then this can inspire confidence that you have some control over the cancer biology. Lactate is perhaps one of the most important cancer biomarker. It tells you the glycolytic state of the cancer, the effect that cancer is having on the immune system, it shows you how the circadian cycle is influencing the cancer ( recent post on forum noted that cancer retires for the night and switches over to OXPHOS. Observing such behavior could be of importance in creating rational treatment plans that responded to such changes. For example, OXPHOS inhibition at night etc..

Encouraging to see how the thread has developed and matured over the last number of months. If we can advance the ideas of nanosyro, lactate monitors etc., then we could expand forward to yet new bounaries of exploration. 

 

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435252/pdf/ijn-10-3499.pdf

They also added in low dose vitamin C and creatine and this further enhanced the benefits of nanoMG. Clinical trials with MG have shown benefit. Bottom figure shows how nanoMG is released almost exclusively in acidic conditions.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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GgE
 GgE
(@gge)
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19/07/2020 4:00 am  
Posted by: @jpizzuto

is putting off starting it as long as she can.

The directions say take with food, but she doesn't eat much.  Most of her nutrition comes from the high fat protein shake I make her.

I can sympathize with her. She has had more than her share...However, I would not give her cancer much of a break because it takes a lot of suffering to regress every little bit that it grows now.

In my humble opinion, these are some of the things that might help her reduce alpelisib's side effects. You can run them through her doctor and see. 

I assume she is on the standard 300 mg a day, which is two 150 mg pills. These are things that I would do:

1- Start with just 1 pill a day for a couple days, to give her body (esp her guts) a chance to get used to it.

2- Take the 2 daily pills as separated as possible, like 1 at breakfast and 1 at dinner. I know they advise to take them together. But this is just my personal opinion. 2 pills together make the CMax twice higher than one, and thus the chances and severity of side effects. As far as I know the AUC (Area under the curve) is about the same and this keeps the cancer cells under siege for a longer time.

3- Light meals with Piqray are OK but low fat is better: "The impact of food on the absorption of alpelisib was investigated in a clinical trial in healthy volunteers (Study CBYL719A2103) after a single 300 mg oral dose of alpelisib. Compared to the fasted state a high-fat high-calorie (HFHC) meal increased – on average – AUCinf by 73% and Cmax by 84%, and a low-fat low-calorie (LFLC) meal increased AUCinf by 77% and Cmax by 145%, confirming a positive food effect on absorption of alpelisib. No significant difference was found for AUCinf between LFLC and HFLC meals. Overall, data from study CBYL719A2103 confirmed that alpelisib must continue to be given with a meal. However as neither composition nor overall calorie intake have shown an effect, the light meal restriction can be lifted, allowing also some further flexibility with regards to alpelisib intake during the day if dose administration has been forgotten in the morning."

4- The main reason many people have to quit Piqray seems to be hyperglycemia, either temporarily or until Piqray is discontinued. This happens because Piqray blocks the cells' access to glucose and thus glucose builds up in the blood. It usually starts in the first few weeks. Many people bring the blood glucose down on their own after a few weeks but some people (most often diabetics and pre-diabetics) can't and need to quit. You may want to buy a glucose meter to check daily if her glucose goes too high for the first few weeks. Your insurance might provide it for free. Or else, if you buy it, you may want to get a combo glucose & lactate meter to get more info for little more money. 

5- Many people develop sores in their mouth which makes it even harder to eat or drink anything. I would buy a bunch of empty capsules and put the pills inside so that the pills don't touch her mouth or esophagus and only get dissolved in the stomach. Because she is eating little, you may want to make cuts and holes in the capsules so that the pills dissolve quickly once they arrive in the stomach before whatever little food she eats goes away.

Patients on everolimus use a corticoid mouth wash from the beginning to avoid stomatitis. You might want to ask about it. It is much better to prevent it than to cure it. Short of that, a Magic Mouth Wash with lydocaine can work.

"the introduction of prophylactic dexamethasone oral solution for the prevention or management of Eve-induced stomatitis has remarkably improved the safety profile of Eve through reducing one of the most common and disturbing toxicities related to the use of this compound [50].

https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-020-01271-0

6- Piqray turns all food and drink flavors into unpleasant for many people. This leads patients to reject all food which compounds the problem. I hope Shirley doesn't get this. Other than the above mouth washes  and OTC Bioten mouth wash I don't have a solution for this problem.

7- Patients on Piqray are advised to reduce sun exposure to reduce their chances of skin rash side effects.

8- Prof. Cantley says that if one follows a ketogenic diet and/or uses Invokana with alpelisib there is a possibility of a cure. I think he is planning to test this theory in a clinical trial. However, you must watch that she doesn't lose much weight. She needs to be strong for the long run.

9- And the most important advise anyone can give: avoid any drinks or foods with rapid release carbohydrates or sugars the hour before and several hours after taking Piqray. That is the most critical time to keep glucose and insulin levels low. If she takes any sugar in this time period then she causes her pancreas to release insulin to her blood and this reduces (or even cancels, depending on the quantity) the effects of Piqray. If one must eat something sweet, better do it out of this time window.


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
19/07/2020 4:21 am  
Posted by: @jcancom

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435252/pdf/ijn-10-3499.pdf

It does not seem too difficult to make for someone with the right expertise and basic lab equipment.


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Jcancom
(@jcancom)
Joined: 3 years ago
Posts: 439
19/07/2020 4:22 am  

GgE, yes I realize that there are challenges, though as I have seen when you have motivated people the pieces can align.


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John Pizzuto
(@jpizzuto)
Joined: 1 year ago
Posts: 200
19/07/2020 4:27 am  

@gge

We have the Keto Mojo meter, which measures glucose and ketones.  We went very low carb two years ago.  She tries to keep below 20g/day.

The shake:

1/4 cup MCT oil, 1/4 cup fish oil, 1/4 cup sour cream, 1/2 cup heavy cream, 2.5oz cream cheese, 1/4 cup cocoa powder, 1 scoop plant based choc flav protein powder, 2 scoops egg white protein powder, water and ice.  About 1900 calories over two-three days.  60g protein, 25g carb.


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GgE
 GgE
(@gge)
Joined: 2 years ago
Posts: 225
19/07/2020 4:57 am  
Posted by: @jpizzuto

We went very low carb two years ago.  She tries to keep below 20g/day.

The shake:

1/4 cup MCT oil, 1/4 cup fish oil, 1/4 cup sour cream, 1/2 cup heavy cream, 2.5oz cream cheese, 1/4 cup cocoa powder, 1 scoop plant based choc flav protein powder, 2 scoops egg white protein powder, water and ice.  About 1900 calories over two-three days.  60g protein, 25g carb.

Is she maintaining her weight and her bone density? No ascites or edemas that can bias the effective weight?


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