Back to resultsEffects of Bashan on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
Primary Purpose
Type 2 Diabetes
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bashan
water
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, glucose, TIR
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with type 2 diabetes;
- 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;
- 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%;
- 18-60 years old;
- Those who have voluntarily signed the informed consent.
Exclusion Criteria:
- Pregnant or lactating women or women planning pregnancy who are unwilling to take or do not take adequate contraceptive measures;
- 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;
- Serious mental illness in the past 6 months;
- Those who have undergone gastrointestinal surgery, except appendicitis and hernia surgery;
- 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).
- Suffering from Cushing's syndrome, pituitary dysfunction and other endocrine system diseases;
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;
- Suffering from infectious diseases such as tuberculosis and AIDS;
- Anemia: hemoglobin < 10g/dl;
- Severe renal insufficiency: GFR ≤ 30ml/min/1.73m2;
- Ketosis, ketoacidosis and uncontrolled infection in recent 1 month;
- Those who are deemed unsuitable for participating in this clinical trial by the researcher for any reason;
Sites / Locations
- Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bashan
Water
Arm Description
a vegetable plant based compound drink add after three meals for 14 days
water as placebo
Outcomes
Primary Outcome Measures
blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring.
Secondary Outcome Measures
insulin C-peptide gastric emptying
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05333822
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, glucose, TIR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bashan
Arm Type
Experimental
Arm Description
a vegetable plant based compound drink add after three meals for 14 days
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
water as placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Bashan
Intervention Description
a vegetable plant based compound drink add after three meals for 14 days
Intervention Type
Other
Intervention Name(s)
water
Intervention Description
water as placebo
Primary Outcome Measure Information:
Title
blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
insulin C-peptide gastric emptying
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 2 diabetes;
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;
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%;
18-60 years old;
Those who have voluntarily signed the informed consent.
Exclusion Criteria:
Pregnant or lactating women or women planning pregnancy who are unwilling to take or do not take adequate contraceptive measures;
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;
Serious mental illness in the past 6 months;
Those who have undergone gastrointestinal surgery, except appendicitis and hernia surgery;
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).
Suffering from Cushing's syndrome, pituitary dysfunction and other endocrine system diseases;
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;
Suffering from infectious diseases such as tuberculosis and AIDS;
Anemia: hemoglobin < 10g/dl;
Severe renal insufficiency: GFR ≤ 30ml/min/1.73m2;
Ketosis, ketoacidosis and uncontrolled infection in recent 1 month;
Those who are deemed unsuitable for participating in this clinical trial by the researcher for any reason;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zilin Sun
Organizational Affiliation
Zhongda Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study didn't plan to share the data
Citations:
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Effects of Bashan on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
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