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Recruiting NCT06315725

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

— Observational Type 1 Diabetes (T1D) Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sweet taste perception with/without sweet taste blockade.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D), Healthy Subjects. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals [Time frame: 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. [Time frame: From enrollment to the end of treatment at 4 weeks]
Secondary outcome measures (1)
  • Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption [Time frame: from enrollment to the end of treatment at 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Canada · 1 center
  • Center for Innovative Medicine, The Research Institute of the McGill University Health Cen — Montreal

Identifiers

NCT: NCT06315725 · 2024-10504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗