Oral Mesoporous Silica Nanoparticles for Delaying Diabetes Progression in Adults With Prediabetes and Obesity

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Mukhtar Ullah
Fatima Tariq
Maham Khalil
Baldev Kumar
Muhammad Abbas Sadiq
Maryam Shehzadi
Muhammad Farman

Abstract

Background: Prediabetes and obesity increase the risk of type 2 diabetes. Oral mesoporous silica nanoparticles (SiPore21) may influence gastrointestinal nutrient digestion and glycemic regulation. Objective: To evaluate the efficacy and short-term tolerability of oral SiPore21 gel in adults with prediabetes and obesity. Methods: A 12-week, double-blind, placebo-controlled randomized trial was conducted in urban Sindh, Pakistan, between June 2025 and January 2026. Eighty adults were randomized equally to SiPore21 gel (3 g three times daily) or matched placebo. Seventy-four participants completed follow-up and were included in complete-case analyses. Primary outcomes were changes in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG). Secondary outcomes included body composition, lipid parameters, and two-hour glucose. Between-group changes were compared using independent-samples t-tests. Results: HbA1c decreased by 0.31 ± 0.18 percentage points with SiPore21 versus 0.03 ± 0.19 with placebo. The between-group difference in change was −0.28 percentage points (95% CI: −0.37 to −0.19; p < 0.001). FPG changes differed by −9.00 mg/dL (95% CI: −11.55 to −6.45; p < 0.001). Secondary metabolic differences favored SiPore21. Mild gastrointestinal adverse events occurred in four intervention and three placebo participants; no severe events were reported. Conclusion: SiPore21 was associated with favorable short-term glycemic outcomes, but longer-term effectiveness, safety, and diabetes prevention remain unestablished.

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How to Cite

[1]
Mukhtar Ullah et al. 2026. Oral Mesoporous Silica Nanoparticles for Delaying Diabetes Progression in Adults With Prediabetes and Obesity. Journal of Health, Wellness and Community Research. 4, 5 (Mar. 2026), 1–10. DOI:https://doi.org/10.61919/abmz4872.

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