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HbA1c levels improve in poorly controlled type 2 patients following non-invasive procedure

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A minimally invasive, upper endoscopic procedure on type 2 diabetes patients leads to improved blood glucose levels, a new study finds. The findings were presented at the World Congress on Intervention Therapies for Type 2 Diabetes and Diabetes Surgery Summit by Alan D. Cherrington, PhD, Professor of Medicine and Molecular Physiology and Biophysics at Vanderbilt University. In Cherrington's study, 39 patients with poorly controlled type 2 diabetes received Duodenal Mucosal Resurfacing (DMR), a procedure developed by Fractyl Laboratories. DMR addresses the intestinal hormone impairment that contributes to insulin resistance, and potentially offers similar benefits to weight loss surgery. It employs novel balloon catheters that can ablate either a short segment or long segment of the duodenum, and changes how the body absorbs and processes sugar. 28 patients received DMR on a long segment (LS-DMR) of the duodenum, while the other 11 patients received DMR on a short segment (SS-DMR). The primary endpoints of the study were safety and reduction in HbA1c levels, which were assessed over a six-month follow-up period. Following the procedure, the patients adopted a low-calorie diet, although there were no specific medication recommendations given. HbA1c reductions After three months, patients treated with LS-DMR had reduced average HbA1c levels compared to SS-DMR patients. In the entire cohort, there was an average HbA1c reduction of 1.2 per cent (13.1 mmol/mol) after six months. There was also a modest average weight reduction among patients, but no correlation was observed by the researchers between the degree of weight loss and HbA1c improvement. Cherrington said: "With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes pathology, and that altering it can meaningfully improve blood sugar control." According to Francesco Rubino, Chair of Bariatric Surgery at King’s College London, these findings are a "huge shift" in how type 2 diabetes is viewed. "Earlier this month, our team published a five-year follow-up study showing that surgery may be more effective than standard medical treatments for the long-term control of type 2 diabetes in obese patients," said Rubino. "This is a huge shift in how we think about the disease. It will be exciting to see if these early results using a much less invasive duodenal mucosal resurfacing approach will be reproduced in larger studies."

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I despair.

No guidance on low calorie diet.
No monitoring on diet.
No relation between hba1c drop and weight loss
The hba1c drop was a mere 1.2%

And they are touting this as the way forward?!?

What utter crud.
 
According to Fractyl's website: "We are currently engaged in clinical trials designed to prove that our innovative procedure can dramatically improve glucose control and reduce the need for additional medications."

A clinical trial that is designed to prove something sounds like it must be rigged.
 
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