Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The diagnosis of diabetes is based on WHO 1999 diagnostic criteria for diabetes, and hemoglobin A1c (HbA1c) measured by standardized testing methods can be used as the supplementary diagnostic criteria for diabetes: Typical diabetes symptoms (polydipsia, polyuria, overeating, unexplained weight loss) plus random blood glucose >= 11.1mmol/L, or fasting blood glucose >= 7.0mmol/L, or oral glucose tolerance test (OGTT) 2-hour blood glucose >= 11.1mmol/L, or HbA1c >= 6.5%; Patients without typical symptoms of diabetes should be reexamined on another day. Type 2 diabetes was diagnosed according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020); 2. Type 2 diabetes mellitus patients with HbA1c = 25% for male and >= 35% for female.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus; Specific types of diabetes due to other causes; 2. Infection: Patients had a history of infection (including respiratory, urinary, digestive or other system infections) within 1 week before enrollment or at the time of enrollment; 3. Cancer; 4. Rheumatic diseases; 5. Liver function injury (six times the upper limit of normal alanine transaminase); 6. Renal insufficiency (creatinine clearance rate 30mg/24h; 7. NYHA >= Grade III; Poor blood pressure control in hypertensive patients; A definite history of coronary heart disease; Unstable arrhythmias; 8. Severe chronic obstructive pulmonary disease; 9. Myasthenia gravis; Dermatomyositis; Duchenne muscular dystrophy; Other neurological, rheumatic or hereditary myopathy; 10. Edema: The body composition analysis report shows that the body moisture content exceeds the upper limit of the standard; 11. Creatine kinase is above the upper limit of normal; 12. Abnormal thyroid function: Confirmed (subclinical) hyperthyroidism or (subclinical) hypothyroidism; 13. Drugs using that affect blood glucose or muscle within 3 months (including glucocorticoids, growth hormones, sex hormones, thyroid hormones, niacin, diazoxide, ß-adrenergic agonists, thiazide diuretics, phenytoin sodium, interferon gamma, etc.); 14. Unable to eat orally; 15. Gastrointestinal malabsorption: such as inflammatory bowel disease, irritable bowel syndrome, gastrointestinal bleeding, chronic diarrhea, etc.; 16. People who have not recovered from sports injuries; People who are unsuitable for sports, such as definite history of cervical or lumbar disc herniation, scoliosis, knee injury, and definite history of osteoarthritis; 17. A history of active drug abuse, including alcohol; 18. A history of diagnosed mental disease; 19. Any conditions that influenced enrollment determined by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c); | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated Albumin (GA);Fasting blood glucose;OGTT 2h blood glucose;Insulin resistance index;Gutt index;Weight;Body mass index (BMI);Waist circumference;Hip circumference;Appendicular skeletal muscle mass (ASM);Skeletal muscle mass index (SMI);Body fat mass (BFM);Percent body fat (PBF);Visceral fat area (VFA);Handgrip strength;Five-time sitting-up time;Triglycerides (TG);Total cholesterol (TC);Low density lipoprotein cholesterol (LDL-C);High density lipoprotein cholesterol;Free fatty acid;The score of the Frail Scale;EQ-5D score;Tumor necrosis factor-alpha (TNF-a);Interleukin-1ß (IL-1ß);IL-2;IL-4;IL-5;IL-6;IL-8;IL-10;Growth hormone (GH);Insulin-Like Growth Factor 1 (IGF-1); | — |
Countries
China
Contacts
Shanghai Jiaotong University School of Medicine, Renji Hospital