Effects of LGI Steam Bread on Glycemia Control in T2DM in China
Not Applicable
Not yet recruiting
- Conditions
- Diabete Type 2
- Registration Number
- NCT06512090
- Lead Sponsor
- Shanghai Punan Hospital of Pudong New District
- 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 control，islet function in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method glucose at 120 mins 120 minutes the blood glucose level at 120 mins after Standard meal test
- Secondary Outcome Measures
Name Time Method glucose at 60 mins 60 minutes The blood glucose at 60 mins after standard meal test
iAUC 120 minutes 120 minutes 120-minute Area under the Curve (iAUC)