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Completed

NCT Number: NCT07593105

Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes

Chronic iron overload represents a significant morbidity in Transfusion dependent β-thalassemia (TDT) leading to various endocrine complications including diabetes. The GLP-1 receptor agonist (GLP-1RA) Dulaglutide has recently been approved for pediatric type 2 diabetes (T2D) treatment.

Objectives: to assess the effect of Dulaglutide versus conventional insulin therapy on glycemic metrics, pancreatic reserve, dyslipidemia and ferritin among children and adolescents with TDT related diabetes.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Egypt

About this study

A randomized controlled trial included 80 children and adolescents with TDT related diabetes. Participants were randomly assigned into two groups; the Dulaglutide group received subcutaneous Dulaglutide (0.75 mg weekly); while the insulin group received conventional basal-bolus insulin therapy. Participants were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, fructosamine, fasting c-peptide, Freestyle libre2 Plus continuous glucose monitoring (CGM), hemolysis markers, serum ferritin, liver enzymes; as well as lipids profile.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes
  • Adolescents 12-18 years old

Exclusion criteria

  • coexisting autoimmune diseases affecting glycemic control (e.g., celiac, autoimmune thyroiditis)
  • diseases that require dietary restriction (e.g., celiac disease, food allergy, eating disorders)
  • chronic diabetes complications (e.g., gastroparesis)
  • and those with other types of diabetes, e.g., type 2 diabetes mellitus (T2D),

Treatment and study plan

Oat Flour

Dietary Supplement

B-glucan oat flakes

Primary outcomes

  1. Glycemic control

    Time frame: 6 months

    Change in HbA1c

Secondary outcomes

  1. Glycemic variability

    Time frame: 6 months

    Change in coefficient of variation

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes: A Randomized Crossover Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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