Type 2 Diabetes
Conditions
Interventions
Low-calorie meal replacement diet group:Low-calorie meal replacement diet
Low-calorie food-based diet group:Low-calorie food-based diet
Control group:Usual medical care according to the most updated Chinese clinical practice guidelines for type 2 diabetes
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18-60 years; 2.Physician-diagnosed type 2 diabetes; 3.Hemoglobin A1c (HbA1c) levels between 6.5%-12.0%; if between 6.0%-6.4%, should be on hypoglycemic medication; 4.Body Mass Index (BMI) between 24-45 kg/m^2; 5.No plan of leaving the place of residence within the next 2 years; 6.Execution of written informed consent and voluntary participation.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes or patients with type 2 diabetes currently taking insulin or with an HbA1c level above 12.0%; 2. Having a cardiovascular event within the previous 6 months; 3. Currently taking weight loss medications including GLP-1 receptor agonists, having eating disorders or dieting behaviors, or weight loss exceeding 5 kilograms in the past 6 months; 4. Chronic kidney disease stage 3b or higher (eGFR < 30 mL/min/1.73 m^2); 5. Any condition causing fluid overload, such as heart failure and cirrhosis; 6. Previously diagnosed mental disorders (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder), uncontrolled depression, or uncontrolled epilepsy; 7. Severe arthritis or active gout; 8. Active gallbladder disease or known asymptomatic gallstones; 9. Participating in another clinical study; 10. Currently pregnant, breastfeeding, or planning to become pregnant; 11. Known cancer; 12. Substance abuse or excessive alcohol use; 13. Fasting C-peptide < 1 ng/mL (331 pmol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of people with at least 10% weight loss;Remission rate of type 2 diabetes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition;Waist circumference ;Fasting blood glucose;Blood pressure;Serum cholesterol;Insulin sensitivity ;Insulin secretory response;Estimated glomerular filtration rate;Alanine transaminase;Aspertate aminotransferase;Liver and pancreatic fat content;Metagenomics;Metabolomics;Diabetes Distress Scale;Self-Rating Anxiety Scale;Patient Health Questionnaire-9;Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactFeng Tao
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed