Diabete Type 2NCT06512090
Effects of LGI Steam Bread on Glycemia Control in T2DM in China
A study testing LGI steam bread and Diabetic diet in people with Diabete Type 2, run by Shanghai Punan Hospital of Pudong New District.
Trial summary
This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- LGI steam bread and Diabetic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2024to 28 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18yrs；
- Diagnosed as Type 2 Diabetes;
- Had been on a stable hypoglycemic regimen for at least 30 days prior to screening；
- HbA1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening;
- Fasting C-peptide ≥1.0ng/ml in the 90 days prior to screening;
- Be willing to accept and adhere to LGI steamed bread as a staple food for at least 14 days
Who cannot join
- Diagnosed with type 1 diabetes, or secondary diabetes;
- Have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease;
- Has unstable CV disorders, including heart failure (NYHA) class III or IV), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥105mmHg);
- An Acute Coronary Syndrome event (ACS) occurred within the 6 months prior to randomization
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Investigate the Effects of Low Glycemic Index（LGI）Related Steamed Bread on Glycemia Control, Islet Function in Patients With Type 2 Diabetes in China: A Single-center, Randomized, Open-label, Prospective Study
This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 diabetes.
- Conditions
- Diabete Type 2
- Being tested
- LGI steam bread, Diabetic diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGI steam breadDietary supplement
LGI Steam bread called "Mangu"steam bread
Diabetic dietDietary supplement
the calorie intake of Diabetic diet will by recommended by nutritionist
| Study group | Role | What they receive |
|---|---|---|
| LGI steam bread intervention group | Experimental | The participant in this group takes LGI steam bread as staple food instead of diabetic diet during the study period. Receives: Dietary Supplement: LGI steam bread |
| Diabetic diet group | Active comparator | he participant in this group takes diabetic diet during the study period. Receives: Dietary Supplement: Diabetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose at 120 mins
the blood glucose level at 120 mins after Standard meal test
Measured: 120 minutes
Secondary outcomes (2)
glucose at 60 mins
The blood glucose at 60 mins after standard meal test
Measured: 60 minutes
iAUC 120 minutes
120-minute Area under the Curve (iAUC)
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start13 Jul 2024 (estimated)
- Primary completion27 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Punan Hospital of Pudong New District
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LianYong Liu, ph.D, Principal investigator, Shanghai Punan Hospital of Pudong New District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512090
- Sponsor's protocol ID
- 2024009
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effects of Low Glycemic Index（LGI）Related Steamed Bread on Glycemia Control, Islet Function in Patients With Type 2 Diabetes in China: A Single-center, Randomized, Open-label, Prospective Study
- ClinicalTrials.gov ID
- NCT06512090
- Acronym / sponsor ID
- 2024009
- Conditions
- Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Punan Hospital of Pudong New DistrictUniversity, hospital or other
- Study start
- 13 Jul 2024 (estimated)
- Primary completion
- 27 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 22 Jul 2024 (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.
This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGI steam bread intervention group | Experimental | Dietary Supplement: LGI steam breadThe participant in this group takes LGI steam bread as staple food instead of diabetic diet during the study period. |
| Diabetic diet group | Active comparator | Dietary Supplement: Diabetic diethe participant in this group takes diabetic diet during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18yrs；
- Diagnosed as Type 2 Diabetes;
- Had been on a stable hypoglycemic regimen for at least 30 days prior to screening；
- HbA1c between 7.5% and 11.0% (both upper and lower limits included) in the 90 days prior to screening;
- Fasting C-peptide ≥1.0ng/ml in the 90 days prior to screening;
Key exclusion criteria (4 listed)
- Diagnosed with type 1 diabetes, or secondary diabetes;
- Have clinically significant liver disease, moderate/severe kidney injury, or end-stage renal disease;
- Has unstable CV disorders, including heart failure (NYHA) class III or IV), intractable angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥105mmHg);
- An Acute Coronary Syndrome event (ACS) occurred within the 6 months prior to randomization
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 |
|---|---|---|
| LGI steam breadLGI Steam bread called "Mangu"steam bread | Dietary supplement | LGI steam bread intervention group |
| Diabetic dietthe calorie intake of Diabetic diet will by recommended by nutritionist | Dietary supplement | Diabetic diet group |
Primary outcome
glucose at 120 mins
Time frame: 120 minutes
the blood glucose level at 120 mins after Standard meal test
2 secondary outcomes
glucose at 60 mins
Time frame: 60 minutes
iAUC 120 minutes
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- 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.
LianYong Liu, ph.D principal investigator
Shanghai Punan Hospital of Pudong New District
Questions about this trial
What is this clinical trial studying?
A study testing LGI steam bread and Diabetic diet in people with Diabete Type 2, run by Shanghai Punan Hospital of Pudong New District.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Wu, ph.D (13774286928, 39606056@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose at 120 mins (time frame: 120 minutes). 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 22 Jul 2024.