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Short-term Effects of Carbohydrate-restricted Diet on Glycemic and Metabolic Control Among Children and Adolescent With Type 1 Diabetes Mellitus

S

Sohag University

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Dietary Supplement: Low carb diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06699485
Soh-Med-15-10-1MS

Details and patient eligibility

About

The current management of type 1 diabetes mellitus (T1DM) involves the use intensive insulin therapy, frequent blood glucose monitoring and carbohydrate counting.

There is a need to strengthen some of the T1DM management aspects as dietary intervention in order to achieve better glycemic and metabolic control.

The international society for pediatric and adolescent diabetes (ISPAD) recommend that children and adolescents with T1DM have about 50% of their total daily caloric requirement from carbohydrates. However, an alternative approach is emerging in recent years. The use of low-carbohydrate diet is suggested to reduce postprandial hyperglycemia and glycemic variability and lower the required insulin.

Enrollment

25 patients

Sex

All

Ages

10 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year attending the Pediatric diabetes clinic at Sohag University Hospital and using the MDI regimen and carbohydrate counting methods are eligible for the study.

Exclusion criteria

  • Children and adolescents with associated diseases such as autoimmune hypothyroidism or celiac disease and those with diabetes-related complications such as diabetic neuropathy, retinopathy or nephropathy will be excluded.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Group 1
Experimental group
Description:
Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year
Treatment:
Dietary Supplement: Low carb diet

Trial contacts and locations

1

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Central trial contact

Ahmed M Mounir, Associate professor; Hadeer S Kamaleldeen, Pediatric Resident

Data sourced from clinicaltrials.gov

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