Breakthrough: possible semi-permanent "cure" for Type 2 diabetes?

Type 2 & MODY T2 Research
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I am not sure how to call it. It is a small study (50 patients), and it is only looking at a 1-year horizon, but, for 90% of the patients, over that duration it seems close to a cure, since it removes the need for insulin:

In the hourlong procedure, trialled on 50 patients in Amsterdam, a tube with a small balloon in its end is inserted through the mouth of the patient down to the small intestine. The balloon is inflated with hot water and the mucous membrane burned away by the heat. Within two weeks a new membrane develops.
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Even a year after the treatment, the disease was found to be stable in 90% of those treated.
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Jacques Bergman, a professor of gastroenterology at Amsterdam UMC, said: “Because of this treatment the use of insulin can be postponed or perhaps prevented. That is promising.”
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Because the question now is whether this is a permanent treatment, or whether it is something that you have to keep repeating – something that in theory should be possible. We looked at whether we could stop their insulin, which is still ongoing, but the first results are truly spectacular, with the lion’s share of patients no longer using insulin after this treatment.”

This appears to be a spectacular breakthrough if it holds out to be true after multiple years. But this is a small study that obviously will need confirmation.

@Gary, what do you think?

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Interesting
 could be a helpful treatment with type 1 too in some cases (there’s a lot of overlap), although probably not a “cure” for t1

I’m glad to see more research into gut mucosa pertaining to many different diseases, for a long time it was seemingly considered nonsense and off in the realm of naturopathy and other vodoo.

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I did a search but couldn’t find the paper they should have given us a link to. I like the Guardian a lot, but this article is not well written, and there could be a lot of missing information.

For one thing it sounds like it isn’t “curing” T2 diabetes, but only keeping subjects from progressing to the point that they require insulin. Yet they apparently still need oral pills. So it improves insulin resistance, but doesn’t eliminate it. (Maybe this is because they don’t lose weight as part of the process). If so, it probably has limited value for most T1 except for those who also have insulin resistance.

Sounds like a bizarre thing to try (burn your intestinal mucous membrane) but it may be related to gastric bypass surgery, which cuts a bunch of nerves and bypasses some of intestine as well as reducing stomach size - and it has been noticed for bypass surgery that T2 diabetes meds are reduced right after surgery even before any weight loss occurs. So this may have been an attempt to achieve a similar thing without requiring major surgery.

They didn’t mention whether this procedure had an effect on body weight - I would guess it doesn’t since that would be a sexier story since everyone is looking for a medical non-surgical weight loss technique.

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This is puzzling to me too: the Guardian is the only source so far. But they are a solid source in general. Still, I am waiting for more info.

I find it interesting that the mucous membrane would be the primary source of insulin resistance apparently.

That said, 50 subjects is very small. But this could be a shocking development if some of it turns out to validate with more people and a longer time horizon.

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@Boerenkool

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Indeed, information is missing. The Guardian did not properly read the Dutch national broadcaster.

Your guess is spot on. The researchers were actually not looking for a cure for T2D, but accidentally discovered this treatment as a side effect of gastric bypass surgery. In the Dutch article, Bergman is quoted about gastric bypass surgeries, saying that these surgeries, as it were, directly connect the stomach to a lower part of the small intestine. Then he makes the statement quoted in the Guardian: “With those people we see a spectacular improvement in blood sugar levels one day after the operation, before they even lose one kilo, which has put us on the track." So this is quote is not about the mucous-burning treatment as the Guardian suggests, but gastric bypass surgeries pointing the researchers in the direction of this new treatment.

According to the link shared by @Thomas, they lost about 3 kg, but it is unknown whether that’s due to the treatment or the dietary advice given to the patients. In the new study, the placebo group will be given the same dietary advice to investigate that.

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@Boerenkool,this is really helpful, thank you!

I am amazed at the lack of coverage. This should be very big news.

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It was on the front pages in the Netherlands, but international media don’t follow us that closely; we’re too tiny. :wink:
Perhaps it’s somewhat old news. Check Google News for e.g. ‘Revita study’ or ‘DMR diabetes’ and you’ll find older articles about this trial. It seems to be a collaboration of multiple research centres in Europe and US, coordinated (?) by a company called Fractyl. They have a website about this trial: http://revitatrial.com/ If you look at Fractyl’s medical advisors, you’ll see professor Bergman is one of them.

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Very interesting! I can see the full trail for this technology:

  • In June 2016 Fractyl announces interesting results for 39 patients for what is, I think, the first version of their technology, endoscopic duodenal mucosal resurfacing, but the results are not as groundbreaking:

https://www.medscape.com/viewarticle/864682

  • In Dec 2017 they complete $44M D round:
  • In June 2018 they announce that they will announce their Revita 1 study results at ADA 2018, but their only claim is that modern diets alter duodenal lining. They don’t claim anything clear about insulin control:

They also announce, in the same release, an FDA-approved Revita-2 study.

This is puzzling. It should be much bigger news. I wonder if the Guardian misreported some of these results.

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Who wouldn’t be excited about a possible cure even if it is only semi-permanent. I could see myself doing this. I do wonder if I would be a candidate for this procedure since I am way past the beginning stage of insulin use.

Since this procedure is designed to reduce insulin resistance it could possibly a game changer for me, The insulin resistant force runs deep in me.

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@joshualevy, I know you are focused on cures for T1, and this does not qualify, but what do you think?

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As you point out, I don’t really follow type-2, but I will give some opinions based on following research in general:

First, I think you are doing the right thing, by looking at the history of the research. In my opinion, you can never tell if research is successful or not by looking at one study’s results. You must always look at what has happened to the entire research program over time. So I think your “full trail” posting is important.

Second, I would ignore news articles and instead look at scientific journal articles, posters, abstracts, conference proceedings, etc. My experience is that general news articles on scientific subjects are terrible sources of information. You can start by looking at articles that report on results from these five clinical studies: https://clinicaltrials.gov/ct2/results?cond=&term=Fractyl+Laboratories&cntry=&state=&city=&dist=&Search=Search

That Guardian article in particular looks like garbage to me. Look at the numbers they posted. There aren’t any! The closest thing to a result published in the news article is “Even a year after the treatment, the disease was found to be stable in 90% of those treated.” That’s worthless.

When I look at results, I often think about how success should be measured and reported in a perfect world, and then I look to see what was really reported. For type-2 diabetes, I think the answer goes something like this: (a) If A1c numbers drop by 0.5 that might be interesting for treatment. (b) If A1c numbers drop by 1.0, that is certainly valuable as a treatment. © If A1c numbers are below 6.5 (and stay there), that is potentially a cure. Now go look at the Guardian coverage. What was the change in A1c numbers? Not reported!

Instead of reading hype in a newspaper, I would go through the published scientific journal articles, and see what impact there has been on A1c numbers. (Someone who knows more about type-2 might have other measurements of a treatment or cure, and that is fine. Look for those.) What I’m trying to say is: don’t look at what was reported; look for what should have been reported. 99% of the general news coverage of science is just a “reporter” repeating what the researchers said. The researchers say good things, so the reporter reports good things. Ignore that. Instead, think about what is important to you, and look for those results.

Obviously, for type-1 diabetes cures, I would look at C-peptide numbers or cure rates, not A1c data.

I was rushed when I wrote this, so it is a little harsh, and I’m sorry for that, but I hope you find it useful.

Joshua

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I think your critiques are totally reasonable. They have not yet published the full results of the Revita 1 study. I have only found publications of single center results so far (the full study is multi-center), which is why I did not post them. FYI, the main single center study publication claims only 5 patients completing 6 months testing, showing -1.3% average decrease in A1c, and 11 patients completing 12 month testing (this looks weird, I know: possibly they inverted these two), showing a -1.5% average decrease in A1c.

I will post the references to the published research when I am on a computer. I think I will also try to contact the main investigator to see if he is willing to share preliminary 1-year results of the full multi-center Revita 1 trial, which I understand is now complete.

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Well, -1.3%Q or -1.5% is a good result (as far as treatment goes). And 11 people for 12 months is a reasonable pilot or early phase-I trial size/length. If I followed type-2, I’d definitely pay attention to their follow-on results.

Joshua

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This is the one results paper I have found (mentioned above). It is only single-center:

A total of 11 patients (n=5 female, 58±11 years) were treated with DMR at UCLH from May 2015 – Dec 2017. Mean (±SEM) change in HbA1c at 3 months post DMR was 0.5% (±0.2) for all patients and −0.7% (±0.2 when one patient was excluded for whom gliclazide had to be stopped due to symptomatic hypoglycaemia in the month following DMR. A total of 5/11 patients completed 6 and 12 months of follow-up with mean changes in HbA1c of −1.3% and −1.5% respectively.

It is puzzling not to find the multi-center REVITA 1 study results in a published paper, since the trial has been completed and the REVITA-2 study has been initiated:

https://www.giejournal.org/article/S0016-5107(18)31840-6/abstract

My guess is that the results are in but the resulting paper has not been published yet. The single center paper was only published this year (2018).

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This is Ginger Vieira’s take on this, she appears quite positive (maybe too optimistic?):