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

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06699485
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-16
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Start: 2025-01-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The blood glucose level	6 months	The blood glucose levels will be measured for the study participants by finger-stick glucometer