NCT06315725 Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)
| NCT ID | NCT06315725 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2025-11-01 |
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 25 participants in total. It began in 2024-11-12 with a primary completion date of 2025-11-01.
⚠ 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 goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time. Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level. To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study. Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker.
Eligibility Criteria
Inclusion Criteria: * Participants with a diagnosis of T1D * HbA1C ≤ 8 % * Insulin pump therapy * Adults of any gender or biological sex aged 18-45 years old, * Body Mass Index (BMI) between 18.5-29.9 kg/m, * Non-smokers, * English or French speaker. ●. Who can consume chicken and fish Exclusion Criteria: * A major medical diagnosis that could potentially influence metabolic dysfunction * A major medical diagnosis other than T1D, * Alcohol or substance use disorder, * Eating disorder or history of malabsorptive syndrome, * Inflammatory bowel disease, * Self-reported impairment in taste or smell, * A known taste or smell dysfunction (e.g., anosmia), * Active pregnancy and/or lactation, * Food allergies or intolerances, * Dislike of the test beverages, * History of bariatric surgery at any point in the past ●. Regular consumer of Gymnema sylvestre
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06315725 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06315725 currently recruiting?
Yes, NCT06315725 is actively recruiting participants. Contact the research team at golnaz.arjmand@mcgill.ca for enrollment information.
Where is the NCT06315725 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06315725 clinical trial?
NCT06315725 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 25 participants.
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