overweight
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Diabetes: fasting blood glucose = 7.0mmol / L or 2 hours after sugar load = 11.1mmol/L. Pre-diabetes: fasting blood glucose <7.0mmol/L, 2 hours after glucose load, blood glucose = 7.8mmol/L but <11.1mmol/L; (2) Body mass index BMI = 26.0 kg / m2; or waist circumference = 90cm (men), waist circumference = 85cm (women); (3) Subjects who are suitable and able to adhere to therapeutic lifestyle interventions without contraindications; (4) Subjects who are volunteered to participate in the study, and who will be able to provide informed consent.
Exclusion criteria
Exclusion criteria: (1) Contraindications for therapeutic lifestyle intervention: type 1 diabetes, severe type 2 diabetes, diabetic nephropathy, severe valvular heart disease, heart failure, aortic aneurysm and dissection aneurysm; infection, deep vein thrombosis, mental illness, central nervous system Disease, hemorrhagic disease, chronic kidney disease including severe kidney stones, gout, renal insufficiency, severe digestive system diseases, anemia, cirrhosis, malignant tumors, gastrointestinal diseases or surgical history, including intestinal obstruction, intestinal ulcer, weight loss surgery or band surgery, gastrointestinal anastomosis, bowel resection, etc.; (2) Cushing/Cushing's syndrome and other obesity caused by diseases of the endocrine system; (3) Progressive malignant tumor or severe disease with poor prognosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change rate of body weight from Baseline to 4 and 8 weeks.;Average change rate of total body fat mass from Baseline to 4 and 8 weeks.;Average change rate of total lean mass from Baseline to 4 and 8 weeks.;Average change rate of fasting blood glucose from Baseline to 4 and 8 weeks.;Average change rate of glycated hemoglobin from Baseline to 4 and 8 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average change rate of glucose profile from Baseline to 4 and 8 weeks, including oral glucose tolerance test (0,30 min, 2h), serum insulin level, homeostasis model insulin resistance index.;Average change rate of lipid profile from Baseline to 4 and 8 weeks, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG);Average change rate of blood pressure from Baseline to 4 and 8 weeks, including systolic blood pressure (SBP), diastolic blood pressure (DBP).;Average change rate of liver enzymes from Baseline to 4 and 8 weeks, including aspartate aminotransferase (AST), alanine aminotransferase (ALT);Average change rate of renal function from Baseline to 4 and 8 weeks, including urea nitrogen (UN), uric acid (UA), creatinine (Cr), estimated glomerular filtration rate (eGFR), ketonuria, microalbuminuria;Average change rate of other hematological indicators from Baseline to 4 and 8 weeks, including IGF-1, IL-6, TNF-a, adiponectin, leptin, hypersensitive c-reactive protein, homocysteine.; | — |
Countries
China
Contacts
The First Affiliated Hospital of Sun Yat-sen University