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

April 11, 2024 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-10504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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