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Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus

H

Hacettepe University

Status

Active, not recruiting

Conditions

Type 1 Diabetes Mellitus

Treatments

Other: Dietary carbohydrate 50-55%
Other: Dietary carbohydrate 30%
Dietary Supplement: fructooligosaccharide and inulin

Study type

Interventional

Funder types

Other

Identifiers

NCT07673523
KA-24037

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 3 patient groups

30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carb
Experimental group
Treatment:
Other: Dietary carbohydrate 30%
50-55% of the daily energy requirement is provided from carbohydrates
Experimental group
Treatment:
Other: Dietary carbohydrate 50-55%
carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp
Experimental group
Treatment:
Dietary Supplement: fructooligosaccharide and inulin

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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