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Canceled by the investigator. Mechanism of dietary AGEs in the pathogenesis of insulin resistance by regulating gut microbiota in subjects with prediabetes

Mechanism of dietary AGEs in the pathogenesis of insulin resistance by regulating gut microbiota in subjects with prediabetes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072724
Enrollment
Unknown
Registered
2023-06-22
Start date
2021-09-14
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prediabetes

Interventions

low dietary AGEs group:The subjects received regular diabetes education and training in cooking methods, such as encouraging subjects to use boiling, stewing and steaming as much as possible, while av
Usual care group:The subjects received regular diabetes education and processed the food according to the routine and habitual cooking method.

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily participate in this clinical study and sign the informed consent; 2.No gender restrictions, age 30 to 75 years old; 3.Prediabetes (fasting blood glucose = 6.1mmol/L and < 7.0mmol/L, or / and 2-hour postprandial blood glucose (OGTT) = 7.8mmol/L and < 11.0mmol/L); 4.Body mass index (BMI) = 18 kg/m2; 5. Blood pressure <160/100 mmHg, triglyceride <5.7 mmol/L; 6. Live in the local area for at least half a year and have a fixed domicile; 7. Have not participated in clinical trials of other drugs within 3 months before the trial; 8. Mental health, able to take care of themselves; 9.Good compliance, eager to change their physical condition, and fully understand the "gut-derived theory of chronic diseases".

Exclusion criteria

Exclusion criteria: 1. Diabetes patients who had been diagnosed; 2. In the past 3 months, the body weight had changed by more than 10%; 3. Antibiotics had been used within the past 2 weeks for 3 or more days; 4. Take intestinal flora regulating drugs two weeks before the test; 5. Pregnant or lactating women, men and women who planed to become pregnant within two years; 6. Alcoholism (drinking more than 5 times a week, with an average of 2 taels of white wine or half a catty of rice wine or more than 5 bottles of beer each time), or drug addicts; 7. Those who had lost weight by any drug method (including appetite suppressants such as fenfluramine, thyroid hormones, progesterone, laxatives, etc. and various traditional Chinese medicine weight loss drugs) or surgical methods in the past 3 months; 8.Thiazolidinediones, glucosidase inhibitors, glucocorticoids, drugs affecting gastrointestinal peristalsis and therapeutic drugs after transplantation were used in the past 3 months; 9. Those who received drug treatment for the following diseases in the past 3 months: cholecystitis, peptic ulcer, IBD, acute urinary tract infection, abnormal thyroid function, etc.;Patients with chronic gastrointestinal diseases with nausea, vomiting and diarrhea in the past one month; 10. Gastrointestinal surgery, except appendicitis and hernia surgery; 11. Abnormal function of pituitary-adrenal axis. 12. Patients with chronic kidney disease or whose blood urea nitrogen and creatinine were 1.2 times higher than the normal upper limit; patients with chronic liver disease (ALT, AST were 2.0 times higher than the normal upper limit); acute or chronic pancreatitis. 13. Suffering from serious organic diseases such as cancer, coronary heart disease, myocardial infarction and stroke. 14. Suffering from infectious diseases such as tuberculosis and AIDS. 15. Suffered from severe mental illness in the past 6 months. 16. Those who were unable to take care of themselves, recall clearly, or answer questions caused by physical disability or other reasons. 17. Patients with severe infection, severe trauma, surgery or other stress situations. 18. Anemia: hemoglobin < 10g/dl. 19. There was an obvious movement disorder. 20. There was no guarantee of sufficient time to participate in this project.

Design outcomes

Primary

MeasureTime frame
HbA1c;half-year incidence of progression to type 2 diabetes mellitus;

Secondary

MeasureTime frame
fasting plasma glucose and 2-hour postprandial blood glucose;insulin resisitance and ß cell function;lipid;Waist circumference and hip circumference;Incidence of reversal to normal glucose metabolism;

Countries

China

Contacts

Public ContactJixiong Xu

The First Affiliated Hospital of Nanchang University

Jixiong.Xu@ncu.edu.cn+86 133 0708 6069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026