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

To Investigate the Effects of Low Glycemic Index（LGI）Related Steamed Bread on Glycemia Control, Islet Function in Patients With Type 2 Diabetes in China: A Single-center, Randomized, Open-label, Prospective Study

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06512090

Enrollment

144

Registered

2024-07-22

Start date

2024-07-13

Completion date

2025-02-28

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2

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.

Interventions

DIETARY_SUPPLEMENTLGI steam bread

LGI Steam bread called Mangusteam bread

DIETARY_SUPPLEMENTDiabetic diet

the calorie intake of Diabetic diet will by recommended by nutritionist

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
glucose at 120 mins	120 minutes	the blood glucose level at 120 mins after Standard meal test

Secondary

Measure	Time frame	Description
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)

Contacts

Primary ContactHong Wu, ph.D

39606056@qq.com13774286928

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026