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

Launched by SHANGHAI PUNAN HOSPITAL OF PUDONG NEW DISTRICT · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a special type of bread, called low glycemic index (LGI) steam bread, can help people with Type 2 diabetes manage their blood sugar levels better. The study aims to find out if eating this bread, which is made to have less impact on blood sugar, can improve how well the body controls glucose and helps the pancreas function. The trial will take place at a single center in China and is not yet recruiting participants.

To be eligible for this study, participants need to be at least 18 years old and have been diagnosed with Type 2 diabetes. They should also be on a stable diabetes medication for at least a month and have certain blood sugar measurements within specified ranges. Participants will need to eat the LGI steam bread as a main food for at least two weeks. It's important to note that people with Type 1 diabetes, certain serious health conditions, or recent heart problems will not be able to join the study. Participants can expect to closely monitor their blood sugar levels while following the new diet during the trial.

Gender

ALL

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