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

NCT ID: NCT06512090

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-13
• Study Completion Date: 2025-02-28

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.

Conditions

Diabete Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LGI steam bread intervention group

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

Group Type: EXPERIMENTAL

LGI steam bread

Intervention Type: DIETARY_SUPPLEMENT

LGI Steam bread called "Mangu"steam bread

Diabetic diet group

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

Group Type: ACTIVE_COMPARATOR

Diabetic diet

Intervention Type: DIETARY_SUPPLEMENT

the calorie intake of Diabetic diet will by recommended by nutritionist

Interventions

LGI steam bread

LGI Steam bread called "Mangu"steam bread

Intervention Type: DIETARY_SUPPLEMENT

Diabetic diet

the calorie intake of Diabetic diet will by recommended by nutritionist

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Punan Hospital of Pudong New District

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LianYong Liu, ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Punan Hospital of Pudong New District

Central Contacts

Hong Wu, ph.D

Role: CONTACT

39606056@qq.com

13774286928

Other Identifiers

2024009

Identifier Type: -

Identifier Source: org_study_id