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Multicenter Study
. 2022 Jan;17(1):9-22.
doi: 10.2217/nnm-2021-0235. Epub 2021 Dec 2.

Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics

Jeanha Baek  1 , Ghislaine Robert-Nicoud  1 , Carmen Herrera Hidalgo  1 , Melissa L Borg  1 , Muhammad N Iqbal  1   2 , Roger Berlin  3 , Maria Lindgren  1 , Erik Waara  1 , Anna Uddén  1 , Kirsi Pietiläinen  4   5 , Tore Bengtsson  6
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Free article
Multicenter Study

Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics

Jeanha Baek et al. Nanomedicine (Lond). 2022 Jan.
Free article

Abstract

Aim: To investigate the effect of oral consumption of engineered mesoporous silica particles, SiPore15®, on long-term blood glucose levels and other metabolic parameters in individuals with prediabetes and newly diagnosed Type 2 diabetes. Method: An open-label, single-arm, multicenter trial was conducted in which SiPore15 was consumed three times daily for 12 weeks. Hemoglobin A1c (HbA1c, primary end point) and an array of metabolic parameters were measured at baseline and throughout the trial. Result: SiPore15 treatment significantly reduced HbA1c by a clinically meaningful degree and improved several disease-associated parameters with minimal side effects. Conclusion: The results from this study demonstrate the potential use of SiPore15 as a treatment for prediabetes that may also delay or prevent the onset of Type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT03823027.

Keywords: HbA1c; Type 2 diabetes; diabetes prevention; medical device; mesoporous silica particles; prediabetes.

Plain language summary

Lay abstract Prediabetes is a health condition in which blood sugar levels are higher than normal but below diabetes diagnosis level. Without intervention, prediabetic adults and children are most likely to progress to Type 2 diabetes. To try and prevent this progression, the authors of this article are proposing an innovative solution with an engineered material called SiPore15®. SiPore15 is classified as a medical device, and is made up entirely of porous silica particles. It has been proven to be safe to take orally. The effects of SiPore15 were investigated in people with prediabetes and newly diagnosed Type 2 diabetes. SiPore15 was taken three times a day for 12 weeks. It significantly reduced long-term blood glucose levels and improved other factors related to the disease with minimal side effects. The results from this study show that SiPore15 has the potential to be used as a treatment for prediabetes. This may help to delay or prevent the onset of Type 2 diabetes. Clinical Trial Registration: NCT03823027 (ClinicalTrials.gov).

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