- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Ankara, Tyrkia (Türkiye), 06100
- Hacettepe University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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Eksperimentell: 50-55% of the daily energy requirement is provided from carbohydrates
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Dietary carbohydrate is 50-55% of daily energy requirements
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Eksperimentell: carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp
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Carbohydrate content of diet
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Continuous Glucose Measuring Device Measurements
Tidsramme: From the enrollment to the end of treatment at 8 weeks
|
From the enrollment to the end of treatment at 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Other measurements
Tidsramme: From the enrollment to the end of the treatment at 12 weeks
|
total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose
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From the enrollment to the end of the treatment at 12 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
- Sykdommer i det endokrine systemet
- Metabolske sykdommer
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Glukosemetabolismeforstyrrelser
- Sukkersyke
- Ernæringsmessige og metabolske sykdommer
- Diabetes mellitus, type 1
- Kostholdskarbohydrater
- Karbohydrater
- Polymerer
- Makromolekylære stoffer
- Polysakkarider
- Stivelse
- Glukaner
- Biopolymerer
- Fruktaner
- Inulin
- Fructooligosaccharide
Andre studie-ID-numre
- KA-24037
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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