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

NCT06512090 | Not Yet Recruiting DMC

• 1 other identifier: 2024009
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• glucose at 120 mins

  the blood glucose level at 120 mins after Standard meal test

  120 minutes

Secondary Outcomes (2)

• glucose at 60 mins

  60 minutes

• iAUC 120 minutes

  120 minutes

Study Arms (2)

LGI steam bread intervention group

EXPERIMENTAL

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

Diabetic diet group

ACTIVE COMPARATOR

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

Dietary Supplement: Diabetic diet

Interventions

LGI steam bread DIETARY_SUPPLEMENT

LGI Steam bread called "Mangu"steam bread

LGI steam bread intervention group

Diabetic diet DIETARY_SUPPLEMENT

the calorie intake of Diabetic diet will by recommended by nutritionist

Diabetic diet group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Punan Hospital of Pudong New District: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Diabetic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• LianYong Liu, ph.D

  Shanghai Punan Hospital of Pudong New District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Wu, ph.D

CONTACT

13774286928; 39606056@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 13, 2024
• Primary Completion: January 27, 2025
• Study Completion: February 28, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share