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

NCT05333822 | Completed

• 1 other identifier: Bashan-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; glucose; TIR

Outcome Measures

Primary Outcomes (1)

• blood glucose improvement in type 2 diabetic patients by continuous glucose monitoring.

  14 days

Secondary Outcomes (1)

• insulin C-peptide gastric emptying

  14 days

Study Arms (2)

Bashan

EXPERIMENTAL

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

Dietary Supplement: Bashan

Water

PLACEBO COMPARATOR

water as placebo

Other: water

Interventions

Bashan DIETARY_SUPPLEMENT

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

Bashan

water OTHER

water as placebo

Water

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%;
• years old;
• Those who have voluntarily signed the informed consent.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

Related Publications (9)

• Zhou M, Astell-Burt T, Bi Y, Feng X, Jiang Y, Li Y, Page A, Wang L, Xu Y, Wang L, Zhao W, Ning G. Geographical variation in diabetes prevalence and detection in china: multilevel spatial analysis of 98,058 adults. Diabetes Care. 2015 Jan;38(1):72-81. doi: 10.2337/dc14-1100. Epub 2014 Oct 28.

  PMID: 25352654 BACKGROUND

• Ji X, Leng XY, Dong Y, Ma YH, Xu W, Cao XP, Hou XH, Dong Q, Tan L, Yu JT. Modifiable risk factors for carotid atherosclerosis: a meta-analysis and systematic review. Ann Transl Med. 2019 Nov;7(22):632. doi: 10.21037/atm.2019.10.115.

  PMID: 31930033 BACKGROUND

• Karagodin VP, Sukhorukov VN, Orekhov AN, Yet SF, Sobenin IA. Atherosclerosis prevention: the role of special diets and functional food. Front Biosci (Elite Ed). 2020 Jan 1;12(1):95-101. doi: 10.2741/E859.

  PMID: 31585871 BACKGROUND

• Post RE, Mainous AG 3rd, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012 Jan-Feb;25(1):16-23. doi: 10.3122/jabfm.2012.01.110148.

  PMID: 22218620 BACKGROUND

• Legeay S, Rodier M, Fillon L, Faure S, Clere N. Epigallocatechin Gallate: A Review of Its Beneficial Properties to Prevent Metabolic Syndrome. Nutrients. 2015 Jul 7;7(7):5443-68. doi: 10.3390/nu7075230.

  PMID: 26198245 BACKGROUND

• Li K, Yao F, Xue Q, Fan H, Yang L, Li X, Sun L, Liu Y. Inhibitory effects against alpha-glucosidase and alpha-amylase of the flavonoids-rich extract from Scutellaria baicalensis shoots and interpretation of structure-activity relationship of its eight flavonoids by a refined assign-score method. Chem Cent J. 2018 Jul 12;12(1):82. doi: 10.1186/s13065-018-0445-y.

  PMID: 30003449 BACKGROUND

• Gu Y, Wang X, Li J, Zhang Y, Zhong H, Liu R, Zhang D, Feng Q, Xie X, Hong J, Ren H, Liu W, Ma J, Su Q, Zhang H, Yang J, Wang X, Zhao X, Gu W, Bi Y, Peng Y, Xu X, Xia H, Li F, Xu X, Yang H, Xu G, Madsen L, Kristiansen K, Ning G, Wang W. Analyses of gut microbiota and plasma bile acids enable stratification of patients for antidiabetic treatment. Nat Commun. 2017 Nov 27;8(1):1785. doi: 10.1038/s41467-017-01682-2.

  PMID: 29176714 BACKGROUND

• Chen C, Zeng Y, Xu J, Zheng H, Liu J, Fan R, Zhu W, Yuan L, Qin Y, Chen S, Zhou Y, Wu Y, Wan J, Mi M, Wang J. Therapeutic effects of soluble dietary fiber consumption on type 2 diabetes mellitus. Exp Ther Med. 2016 Aug;12(2):1232-1242. doi: 10.3892/etm.2016.3377. Epub 2016 May 20.

  PMID: 27446349 BACKGROUND

• Fan J, Johnson MH, Lila MA, Yousef G, de Mejia EG. Berry and Citrus Phenolic Compounds Inhibit Dipeptidyl Peptidase IV: Implications in Diabetes Management. Evid Based Complement Alternat Med. 2013;2013:479505. doi: 10.1155/2013/479505. Epub 2013 Aug 29.

  PMID: 24069048 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Zilin Sun

  Zhongda Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 19, 2022
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2022
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)