- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07673523
Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide (FOS) Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
Diabetes is a chronic metabolic disease in which nutrients such as carbohydrates, fats and proteins cannot be utilized sufficiently due to the inability to produce insulin or defects in the effect of the produced insulin. The risk of individuals encountering complications related to diabetes decreases when glycemic control is achieved in these patients. Therefore, nutrition is an necessary component of treatment. Although there are many studies in the literature examining the effect of carbohydrate intake on glycemic control in individuals with diabetes and monitoring carbohydrate intake in individuals with diabetes is the basic strategy for reaching glucose targets, a common denominator has not yet been reached for the optimal amount of carbohydrate intake for individuals with diabetes. There are a wide range of definitions regarding carbohydrate intake and studies on carbohydrate restriction, especially in individuals with Type 1 diabetes, are limited.
In present randomized controlled crossover study, three isocaloric different dietary treatment are planned to applied for 2 weeks in which (i) 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carbohydrates according to the individual characteristics of the patients, (ii) 50-55% of the daily energy requirement is provided from carbohydrates and (iii) carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supplementing 2 sachets (1 sachet 3.68 g inulin + 3.68 g ) where 50-55% of daily energy requirement is provided from carbohydrates together with fructooligosaccharide (FOS)) inulin fructooligosaccharide (FOS) supplementation. A 2-week washout period is planned between each diet model. The research will be conducted with 20 individuals with Type 1 diabetes using a Continuous Glucose Monitoring device. The proposed project aims to investigate the effect of different dietary treatments on glycemic control in individuals with Type 1 diabetes by using a continuous glucose measuring device. At the end of each dietary treatment application, the data obtained from the Continuous Glucose Measuring Device will be evaluated as the primary outcomes; total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose will be evaluated as the secondary outcomes. As a result of the research, the potential effects of different dietary treatments on glycemic control will be evaluated and the development of the most appropriate diet model for these patients will be contributed. In addition, this research will contribute to the improvement of the continuous glucose monitoring device.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Ankara, Turkije (Türkiye), 06100
- Hacettepe University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Patients aged 18-65 years diagnosed with Type 1 diabetes and currently using a Continuous Glucose Monitoring device
Exclusion Criteria:
- Individuals with type 2 diabetes
- Individuals with gestational diabetes
- Breastfeeding individuals
- Individuals with celiac disease
- Individuals with gastroparesis
- Renal insufficiency (tGFR ≤ 60 ml/min/1.73 m2)
- Diagnosed liver failure
- Immunodeficiency
- Individuals with malignancy
- Using nutritional supplements that may affect metabolic parameters
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carb
|
Dietary carbohydrate is 30% of daily energy requirements
|
|
Experimenteel: 50-55% of the daily energy requirement is provided from carbohydrates
|
Dietary carbohydrate is 50-55% of daily energy requirements
|
|
Experimenteel: carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp
|
Carbohydrate content of diet
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Continuous Glucose Measuring Device Measurements
Tijdsspanne: From the enrollment to the end of treatment at 8 weeks
|
From the enrollment to the end of treatment at 8 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Other measurements
Tijdsspanne: From the enrollment to the end of the treatment at 12 weeks
|
total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose
|
From the enrollment to the end of the treatment at 12 weeks
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Metabole ziekten
- Auto-immuunziekten
- Ziekten van het immuunsysteem
- Glucosemetabolismestoornissen
- Suikerziekte
- Voedings- en stofwisselingsziekten
- Diabetes mellitus, type 1
- Koolhydraten in de voeding
- Koolhydraten
- Polymeren
- Macromoleculaire stoffen
- Polysachariden
- Zetmeel
- Glucanen
- Biopolymeren
- Fructanen
- Inuline
- fructooligosaccharide
Andere studie-ID-nummers
- KA-24037
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .