Effects of Bashan on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms

NCT ID: NCT05333822

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-31

Brief Summary

The study aimed to observe the effect of targeted diet on blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring and to explore the possible mechanism of targeted diet on blood glucose improvement in type 2 diabetic patients.

Detailed Description

Subjects were studied on 2 occasions, separated by at least 7 days, in a randomized fashion. The order of the enteral infusions was randomized and facilitated by a biostatistician who generated the randomization code and a research officer who prepared the study solutions, but were not involved in data collection or analysis. Each occasion would last for 14 days maintaining daily eating habits without intervention and take 180ml mineral water or Bashan three times a day after meals. During the 2-week test, all subjects will still wear continuous glucose monitoring systems. Before and after the intervention, the standard meal test would be carried out on the subjects, and the samples of serum and feces, etc. of the subjects would be collected for the following tests.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bashan

a vegetable plant based compound drink add after three meals for 14 days

Group Type: EXPERIMENTAL

Bashan

Intervention Type: DIETARY_SUPPLEMENT

a vegetable plant based compound drink add after three meals for 14 days

Water

water as placebo

Group Type: PLACEBO_COMPARATOR

water

Intervention Type: OTHER

water as placebo

Interventions

Bashan

a vegetable plant based compound drink add after three meals for 14 days

Intervention Type: DIETARY_SUPPLEMENT

water

water as placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes;

2. With only diet and exercise control for at least 3 months or stable use of basal insulin for hypoglycemic treatment for at least 3 months;

3. Fasting blood glucose is greater than 7.0mmol/L, 2h postprandial blood glucose is greater than 11.1mmol/L, and glycosylated glycoprotein is 7.0-8.5%;

4. 18-60 years old;

5. Those who have voluntarily signed the informed consent.

Exclusion Criteria

1. Pregnant or lactating women or women planning pregnancy who are unwilling to take or do not take adequate contraceptive measures;

2. Drinking (more than 5 times a week, and 100g liquor or 250g yellow wine or 5 bottles of beer above on average each time) or smoking history;

3. Serious mental illness in the past 6 months;

4. Those who have undergone gastrointestinal surgery, except appendicitis and hernia surgery;

5. Patients with chronic or persistent hepatitis, patients with severe liver disease such as cirrhosis, or those whose hepatitis B surface antigen (HBsAg) is positive and is accompanied by abnormal liver function (serum glutamic pyruvic transaminase and aspartate aminotransferase are 2.5 times the normal value).

6. Suffering from Cushing's syndrome, pituitary dysfunction and other endocrine system diseases;

7. Factors that hinder participation in the research, such as unstable medical conditions, including blood pressure and cardiovascular disease, etc.

i. malignant hypertension (blood pressure > 180/110mmHg, systolic blood pressure > 180mmHg or diastolic blood pressure > 110mmHg); unstable blood pressure control; ii. myocardial infarction, other acute cardiac events requiring hospitalization, stroke, transient ischemic attack, or treatment of acute congestive heart failure;

8. Suffering from infectious diseases such as tuberculosis and AIDS;

9. Anemia: hemoglobin < 10g/dl;

10. Severe renal insufficiency: GFR ≤ 30ml/min/1.73m2;

11. Ketosis, ketoacidosis and uncontrolled infection in recent 1 month;

12. Those who are deemed unsuitable for participating in this clinical trial by the researcher for any reason;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zilin Sun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zilin Sun

Role: STUDY_CHAIR

Zhongda Hospital

Locations

Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University

Nanjing, Jiangsu, China

Countries

China

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Other Identifiers

Bashan-01

Identifier Type: -

Identifier Source: org_study_id