Clincosm LogoSign in Get a demo

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

Sponsor
Zhongda Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05333822
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Bashan
  • Other: water
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Bashan,a Vegetable Plant Based Compound Drink , on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bashan

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

Dietary Supplement: Bashan
a vegetable plant based compound drink add after three meals for 14 days
Placebo Comparator: Water

water as placebo

Other: water
water as placebo

Outcome Measures

Primary Outcome Measures

  1. blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring. [14 days]

Secondary Outcome Measures

  1. insulin C-peptide gastric emptying [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. 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;

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

  2. Anemia: hemoglobin < 10g/dl;

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

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University Nanjing Jiangsu China

Sponsors and Collaborators

  • Zhongda Hospital

Investigators

  • Study Chair: Zilin Sun, Zhongda Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zilin Sun, Professor, Zhongda Hospital
ClinicalTrials.gov Identifier:
NCT05333822
Other Study ID Numbers:
  • Bashan-01
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zilin Sun, Professor, Zhongda Hospital
type 2 diabetes
glucose
TIR
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 19, 2022