Diabetes
Conditions
Interventions
Continuous energy limitation group:Continuous energy restriction
Experimental group 3:Time-Restricted Eating 10h
Sponsors
Department of Endocrinology of the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 65 years; 2. Meet the ADA (2010) diagnostic criteria for type 2 diabetes; 3. The course of diabetes mellitus is less than or equal to 5 years, and hypoglycemic drugs have not been used or used irregularly in recent 3 months (the drugs have not been used regularly for 2 consecutive weeks in recent 3 months, and the elution period needs 2 weeks); 4. BMI >=28kg/m^2 and waist circumference >= 85cm for women and >= 90cm for men; 5. HbA1c 6.5%-8.9%; 6. Stable body weight (body weight fluctuation < 5% in the first 3 months).
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of diabetes other than type 2 diabetes; 2. There were acute metabolic complications within 6 months before screening, including lactic acidosis, nonketotic hyperosmolar coma and diabetic ketoacidosis; 3. Patients with severe acute and chronic complications of diabetes (such as myocardial infarction, cerebrovascular accident, blindness caused by diabetic retinopathy and severe foot ulcer, etc.); 4. Those who have other endocrine diseases other than type 2 diabetes and are being treated and not under control; 5. Hypoglycemia that is easy to recur according to the researcher's judgment; 6. Taking drugs that affect weight (such as orlistat, glucocorticoid, etc.) or drugs that affect appetite and gastrointestinal motility in the past 3 months; 7. Severe liver function damage (ALT = 3 ULN); Severe renal insufficiency (EGFR = 60ml/min/1.73m2); 8. Heart failure (NYHA ? ~ ?); 9. Serious blood system diseases (such as thalassemia and iron deficiency anemia); 10. Alcohol consumption is more than 140 g/week for men and more than 70 g/week for women; 11. Those who are mentally ill and unable to cooperate with the test; 12. Those who cannot eat by mouth; History of gastrointestinal surgery; Oral use of antibiotics in the past 3 months; Oral use of probiotic foods in the past week; 13. Those who are intolerant or allergic to the ingredients of meal replacement packages; 14. Pregnant and lactating women; 15. Have a history of tumor within 5 years; 16. Participated in other clinical trials three months before screening; 17. Those who follow a special diet (such as vegetarian diet, ketogenic diet, etc.) and have followed the diet pattern of IER or CER.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight;Fasting blood glucose;Time of glucose within target range within 24h;Human body composition;Intestinal microbiota;Quality of life;Biochemical indicator;Biological clock gene; | — |
Countries
China
Contacts
Public ContactZhang Haohao
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed