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

NCT ID: NCT06315725

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2027-12-01

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.

Conditions

Type 1 Diabetes (T1D); Healthy Subjects

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: OTHER

Interventions

Sweet taste perception with/without sweet taste blockade

In our study, we will use our four different novel flavored beverages, with and without a sweet taste blockade.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Dana Small

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Innovative Medicine, The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Golnaz Arjmand, PhD

Role: CONTACT

golnaz.arjmand@mcgill.ca

514-398-3020

Facility Contacts

Golnaz Arjmand, Postdoctoral Researcher

Role: primary

golnaz.arjmand@mcgill.ca

514-398-3020

Other Identifiers

2024-10504

Identifier Type: -

Identifier Source: org_study_id