Clinical trial NCT05333822: Effects of Bashan on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
Official title: Effects of Bashan,a Vegetable Plant Based Compound Drink , on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
glucose
TIR
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring.
timeFrame: 14 days
Secondary outcomes:
measure: insulin C-peptide gastric emptying
timeFrame: 14 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Zilin Sun
role: STUDY_CHAIR
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