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Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D) (AFS_T1D)

1 oktober 2026 uppdaterad av: Dana Small, McGill University Health Centre/Research Institute of the McGill University Health Centre

A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients With Type 1 Diabetes

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Övrig: Sweet taste perception with/without sweet taste blockade

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Kanada
- Quebec
  - Montreal, Quebec, Kanada, H4A 3J1
    - Center for Innovative Medicine, The Research Institute of the McGill University Health Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: CASE_CROSSOVER
Tidsperspektiv: OTHER

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals Tidsram: from enrollment to the end of treatment at 4 weeks	our aim is to test whether the impact of consuming NNS with carbohydrates on glucose metabolism is related to oral or post-oral sweet taste receptor signaling.	from enrollment to the end of treatment at 4 weeks
Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption. Tidsram: From enrollment to the end of treatment at 4 weeks	Consuming NNS alongside carbohydrates affects glucose metabolism differently compared to carbohydrates alone in participants with type 1 diabetes (T1D) using an artificial pancreas (AP) system for exogenous insulin production	From enrollment to the end of treatment at 4 weeks

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption Tidsram: from enrollment to the end of treatment at 4 weeks	To test whether the co-ingestion of the NNS with carbohydrate can result in changes in post-ingestion metabolism, we plan to employ indirect calorimetry (IC) to evaluate resting energy expenditure (REE) before and after flavoured beverages consumption.	from enrollment to the end of treatment at 4 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 november 2024

Primärt slutförande (Faktisk)

22 september 2026

Avslutad studie (Faktisk)

22 september 2026

Studieregistreringsdatum

Först inskickad

12 mars 2024

Först inskickad som uppfyllde QC-kriterierna