Condition: Glycogen Storage Disease Type I · Sponsor: Federico II University
The aim of this observational study is to evaluate the impact of raw cornstarch supplementation on postprandial glycemic response in adult patients with Glycogen Storage Disease type I (GSD I), using continuous glucose monitoring (CGM) systems.GSD I is a rare inherited metabolic disorder characterized by impaired glucose homeostasis during fasting, leading to recurrent hypoglycemia and metabolic abnormalities. Nutritional therapy, based on frequent carbohydrate intake and raw cornstarch supplementation, represents the cornerstone of treatment. However, the optimal timing of raw cornstarch administration in relation to meals and its effect on postprandial glycemic control remain unclear.The main question this study aims to answer is: "Does raw cornstarch intake during meals affect postprandial glycemic response in adult patients with Glycogen Storage Disease type I?". Additional objectives include evaluating whether dose and timing of cornstarch intake influences glucose profile, glycemic variability, hypoglycemic events, body composition, energy expenditure, and lipid profile. Participants will include adults with genetically confirmed GSD Ia or Ib who routinely use CGM systems and regularly consume raw cornstarch as part of their dietary management. This is a real-life observational study, and participants will continue their routine clinical care without receiving additional experimental treatments. After providing informed consent, participants will undergo clinical, metab…
This description comes directly from the study's public registry record.
Roberta Lupoli Associated Professor, Medical Director at the AOU Federico II · +39 0817462302 · roberta.lupoli@unina.it
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| AOU Policlinico "Federico II" | Naples, Napoli, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07645898