NCT07593105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Type 1 DiabetesNutrition

Keywords

AdolescentsType 1 diabetesHigher fiber dietGlycemic variability

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Change in HbA1c

    6 months

Secondary Outcomes (1)

  • Glycemic variability

    6 months

Study Arms (2)

B-glucan

ACTIVE COMPARATOR

B-glucan supplelentation

Dietary Supplement: Oat Flour

control

NO INTERVENTION

No add on intervention

Interventions

Oat FlourDIETARY_SUPPLEMENT

B-glucan oat flakes

B-glucan

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Type 1 Diabetes
  • Adolescents 12-18 years old

You may not qualify if:

  • 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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

October 12, 2024

Primary Completion

November 12, 2025

Study Completion

February 12, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)