Effects of LGI Steam Bread on Glycemia Control in T2DM in China

Shanghai Punan Hospital of Pudong New District

Status: Not yet enrolling

Conditions: Diabete Type 2

Treatments: Dietary Supplement: Diabetic diet; Dietary Supplement: LGI steam bread

Study type: Interventional

Funder types: Other

Identifiers

NCT06512090

2024009

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

LGI steam bread intervention group

Experimental group

Description:

The participant in this group takes LGI steam bread as staple food instead of diabetic diet during the study period.

Treatment:

Dietary Supplement: LGI steam bread

Diabetic diet group

Active Comparator group

Description:

he participant in this group takes diabetic diet during the study period.

Treatment:

Dietary Supplement: Diabetic diet