Type 1 DiabetesNCT07593105
Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes
A study testing Oat Flour in people with Type 1 Diabetes and Nutrition, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Nutrition
- What is being tested?
- Oat Flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2024to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 Diabetes
- Adolescents 12-18 years old
Who cannot join
- 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),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes: A Randomized Crossover Study
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.
- Conditions
- Type 1 Diabetes, Nutrition
- Being tested
- Oat Flour
- Keywords
- Adolescents, Type 1 diabetes, Higher fiber diet, Glycemic variability
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat FlourDietary supplement
B-glucan oat flakes
| Study group | Role | What they receive |
|---|---|---|
| B-glucan | Active comparator | B-glucan supplelentation Receives: Dietary Supplement: Oat Flour |
| control | No intervention | No add on intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Change in HbA1c
Measured: 6 months
Secondary outcomes (1)
Glycemic variability
Change in coefficient of variation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start12 Oct 2024
- Primary completion12 Nov 2025
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593105
- Sponsor's protocol ID
- MS 362/2024
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07593105
- Acronym / sponsor ID
- MS 362/2024
- Conditions
- Type 1 Diabetes, Nutrition
- Keywords
- Adolescents, Type 1 diabetes, Higher fiber diet, Glycemic variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-glucan | Active comparator | Dietary Supplement: Oat FlourB-glucan supplelentation |
| control | No intervention | –No add on intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 Diabetes
- Adolescents 12-18 years old
Key exclusion criteria (4 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oat FlourB-glucan oat flakes | Dietary supplement | B-glucan |
Primary outcome
Glycemic control
Time frame: 6 months
Change in HbA1c
1 secondary outcome
Glycemic variability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat Flour in people with Type 1 Diabetes and Nutrition, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.