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CompletedNCT07593105Updated May 18, 2026

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

An interventional study of Oat Flour in Type 1 Diabetes and Nutrition, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Ain Shams University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2024, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes
  • Nutrition

Keywords

  • Adolescents
  • Type 1 diabetes
  • Higher fiber diet
  • Glycemic variability
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 1 Diabetes
  • Adolescents 12-18 years old

Exclusion criteria

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),
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    B-glucan

    B-glucan supplelentation

    Dietary Supplement: Oat Flour

  • No intervention
    control

    No add on intervention

Interventions

  • Dietary supplementOat Flour

    B-glucan oat flakes

06

What researchers measure

Primary outcomes

  1. Glycemic control

    Change in HbA1c

    Time frame: 6 months

Secondary outcomes

  1. Glycemic variability

    Change in coefficient of variation

    Time frame: 6 months

07

Study locations

1 site
  • Ain shams university
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07593105
Lead sponsor
Ain Shams University
Responsible party
Nouran yousef (Dr, Ain Shams University) — Principal investigator
First posted
May 18, 2026
Start date
Oct 12, 2024
Primary completion
Nov 12, 2025
Completion
Feb 12, 2026
Last update
May 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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