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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Center for Innovative Medicine, The Research Institute of the McGill University Health Centre
RECRUITING
Montreal
Contact Information
Primary
Golnaz Arjmand, PhD
golnaz.arjmand@mcgill.ca
514-398-3020
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 25
Related Therapeutic Areas
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov