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Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D)

Study acronym: AFS_T1D
StatusTerminated
PhaseNot specified
Started
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Record History

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  1. Trial terminated Sponsor's reason: The study was terminated due to recruitment difficulties. Only three participants enrolled within two years due to specific insulin pump requirements. Recruitment was therefore discontinued before the planned sample size was reached. Show 6 more changesShow less
    • Primary completion date changed from estimate of Nov 1, 2025 to Sep 22, 2026
    • Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre to McGill University Health Centre/Research Institute of the McGill University Health Centre
    • Final enrollment: 3 participants (planned 25)
    • Interventions: Sweet taste perception with/without sweet taste blockade (Other) to Sweet taste perception with/without sweet taste blockade (Other)
    • Eligibility criteria expanded, about 18 words
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Sep 1, 2025 to Nov 1, 2025
    • Study completion date: Sep 1, 2027 to Dec 1, 2027
    • Start date changed from estimate of Sep 1, 2024 to Nov 12, 2024
    • Eligibility criteria expanded, about 13 words
  3. Interventions: 1- maltodextrin, 2- maltodextrin plus sucralose (combo), 3- combo with oral sweet taste receptors blocked 4- combo with extra oral sweet… to Sweet taste perception with/without sweet taste blockade (Other)
    • Eligibility criteria shortened, about 106 words
    • Secondary endpoint revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06315725
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 Type 1 Diabetes (T1D), Healthy Subjects
Related terms Diabetes Mellitus, Type 1, Insulin Resistance
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov