Status:
NOT_YET_RECRUITING
Effects of LGI Steam Bread on Glycemia Control in T2DM in China
Lead Sponsor:
Shanghai Punan Hospital of Pudong New District
Conditions:
Diabete Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 contro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06512090
Start Date
July 13 2024
End Date
February 28 2025
Last Update
July 22 2024
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