Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D) (AFS_T1D)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Center for Innovative Medicine, The Research Institute of the McGill University Health Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CROSSOVER
- Tidsperspektiver: OTHER
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
Tidsramme: 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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-10504
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .