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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07593105

Enrollment

Registered

2026-05-18

Start date

2024-10-12

Completion date

2026-02-12

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Type 1 Diabetes

Keywords

Adolescents, Type 1 diabetes, Higher fiber diet, Glycemic variability

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTOat Flour

B-glucan oat flakes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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),

Design outcomes

Primary

Measure	Time frame	Description
Glycemic control	6 months	Change in HbA1c

Secondary

Measure	Time frame	Description
Glycemic variability	6 months	Change in coefficient of variation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026