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

July 19, 2024 updated by: Shanghai Punan Hospital of Pudong New District

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: LGI steam bread
LGI Steam bread called "Mangu"steam bread
Active Comparator: Diabetic diet group
he participant in this group takes diabetic diet during the study period.
Dietary supplement: Diabetic diet
the calorie intake of Diabetic diet will by recommended by nutritionist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose at 120 mins
Time Frame: 120 minutes
the blood glucose level at 120 mins after Standard meal test
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose at 60 mins
Time Frame: 60 minutes
The blood glucose at 60 mins after standard meal test
60 minutes
iAUC 120 minutes
Time Frame: 120 minutes
120-minute Area under the Curve (iAUC)
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Punan Hospital of Pudong New District

Investigators

  • Principal Investigator: LianYong Liu, ph.D, Shanghai Punan Hospital of Pudong New District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 13, 2024

Primary Completion (Estimated)

January 27, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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