NCT07645898 Use of Continuous Glucose Monitoring to Evaluate Postprandial Response to Raw Cornstarch Supplementation in Adult Glycogen Storage Disease Type I
| NCT ID | NCT07645898 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Glycogen Storage Disease Type I |
| Study Type | OBSERVATIONAL |
| Enrollment | 8 participants |
| Start Date | 2026-02-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8 participants in total. It began in 2026-02-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, metabolic, and nutritional assessments, including: * anthropometric measurements; * body composition analysis by bioelectrical impedance; * indirect calorimetry for resting energy expenditure; * handgrip strength evaluation; * biochemical analyses, including fasting glucose, HbA1c, lipid profile, liver enzymes, creatinine, uric acid, and lactate. CGM-derived parameters collected during the 14 days preceding the visit will be analyzed, including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), coefficient of variation (CV%), Glucose Management Indicator (GMI), and frequency of hypoglycemic episodes. Participants will also complete a 7-day food diary reporting meal timing, food intake, and raw cornstarch consumption. Investigators will compare meals consumed with and without raw cornstarch supplementation and evaluate postprandial glycemic trends. Postprandial glycemic response will be assessed using dynamic indices, including glucose peak, nadir, time to peak, time to nadir, glucose excursion rates, and incremental area under the curve (iAUC). Glucose values will be analyzed every 5 minutes for up to 4 hours after meals using CGM data. Inclusion criteria include: genetically confirmed GSD Ia or Ib, age \>18 years, routine CGM use, and habitual raw cornstarch consumption.Exclusion criteria include psychiatric disorders, pregnancy, celiac disease, dialysis treatment, nocturnal enteral feeding, and severe acute or chronic illnesses. Approximately 8 adult patients are expected to be enrolled. Risks for participants are considered minimal, as all procedures are part of routine clinical follow-up. Potential benefits include improved personalization of nutritional therapy and optimization of carbohydrate and raw cornstarch administration, potentially improving glycemic control and reducing metabolic complications in patients with GSD I.
Eligibility Criteria
Inclusion Criteria: * confirmed genetic diagnosis of GSD Ia or Ib; * age \>18 years; * routine CGM use; * habitual raw cornstarch consumption. Exclusion Criteria: * psychiatric disorders; * pregnancy, celiac disease; * dialysis treatment; * nocturnal enteral feeding; * severe acute or chronic illnesses.
Contact & Investigator
Roberta Lupoli Associated Professor, Medical Director at the AOU Federico II
✉ roberta.lupoli@unina.it📞 +39 0817462302
Frequently Asked Questions
Who can join the NCT07645898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glycogen Storage Disease Type I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07645898 currently recruiting?
Yes, NCT07645898 is actively recruiting participants. Contact the research team at roberta.lupoli@unina.it for enrollment information.
Where is the NCT07645898 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07645898 clinical trial?
NCT07645898 is sponsored by Federico II University. The trial plans to enroll 8 participants.