diabetes
Conditions
Interventions
A:Regular carbohydrate staple food
B:Low-carbohydrate staple food
C:Low-carbohydrate staple food + Prebiotics
Sponsors
Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18-75 years old. (2) The course of type 2 diabetes is more than 3 months, the current diet control or oral drug or insulin treatment, stable program for more than 1 month. (3) Be able to follow the basic diet and exercise plan. (4) Fasting blood glucose <= 10.0mmol/L, and 7.0 <= HbA1c <= 9.0%. (5) Can measure blood glucose and can use a smartphone. (6) Have not participated in any drug clinical trials within 30 days. (7) Voluntarily participate in this project and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who have long-term plans to go out within 3 months after being selected, or who have obvious irregular diet and life. (2) Those with a history of long-term digestive tract diseases (such as persistent obvious abdominal pain, diarrhea, peptic ulcer or taking digestive enzyme preparations within 2 weeks, etc.). (3) Patients with hyperthyroidism and Cushing's syndrome and other diseases that affect glucose metabolism, and those with obvious diabetic autonomic neuropathy. (4) Those with a history of severe heart and cerebrovascular diseases in the 3 months prior to the signing of informed consent, unable to move or eat normally, severe cardiac and cerebrovascular diseases including but not limited to: myocardial infarction, cardiac surgery or angioplasty (coronary bypass grafting or percutaneous coronary angioplasty), unstable angina, unstable heart failure, New York Heart Association (NYHA) grade IV congestive heart failure, transient ischemic attack or severe cerebrovascular disease, unstable or previously undiagnosed arrhythmias. (5) Those who were treated with a-glycosidase inhibitors, DPP-4 inhibitors, SGLT2i or GLP-1RA within 1 month before the signing of informed consent. Recent use of drugs that affect glucose metabolism, such as glucocorticoids. (6) If there is obvious abnormality in liver function, the ALT or AST test result is 3 times or even higher than the upper limit of normal, the creatinine increase is 1.2 times more than the normal high value or eGFR is calculated < 60ml/min. (7) Those with severe allergies and allergies to wheat bran, eggs, soy products or other food ingredients. (8) Body mass index < 21 kg/m^2. (9) Those with a long-term history of alcohol or drug abuse. (10) Pregnant women or those who intend to become pregnant recently, or lactating women. (11) Vulnerable groups, including the mentally ill, cognitively impaired, critically ill, illiterate, etc. (12) Those who the investigator believes are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;????????;TIR; | — |
Secondary
| Measure | Time frame |
|---|---|
| triglyceride;URIC;Weight;WC;Intestinal flora;Systolic blood pressure;Diastolic blood pressure;Total cholesterol;HDL;LDL;CRP;Body composition;Urinary ketone bodies;finger-prick blood glucose;Serum metabolites; | — |
Countries
China
Contacts
Public ContactZhou Jiaqiang
Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Outcome results
None listed