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

Recruiting now

Conditions studied: Type 1 Diabetes (T1D), Healthy Subjects

In brief

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.

Key facts

Study ID

NCT06315725

Run by

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

People needed

25

Starts

2024-11-12

Expected to finish

2027-12-01

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Innovative Medicine, The Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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