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

Not Applicable

Not yet recruiting

• Conditions: Diabete Type 2
• Interventions: Dietary Supplement: LGI steam bread; Dietary Supplement: Diabetic diet

• 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

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-13
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-01-27
• Study Completion: 2025-02-28

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

Arm && Interventions

Group	Intervention	Description
LGI steam bread intervention group	LGI steam bread	The participant in this group takes LGI steam bread as staple food instead of diabetic diet during the study period.
Diabetic diet group	Diabetic diet	he participant in this group takes diabetic diet during the study period.

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
iAUC 120 minutes	120 minutes	120-minute Area under the Curve (iAUC)
glucose at 60 mins	60 minutes	The blood glucose at 60 mins after standard meal test