obesity
Conditions
Interventions
Cai's therapeutic intervention group:Cai's therapeutic intervention group
Non intervention group:Non intervention
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. if the patient is older than 18 years old refer to the diagnosis of adult obesity or overweight (Chinese standard): overweight is 24 kg/m2 = BMI < 28 kg/m2 obesity is BMI = 28 kg/m2. 2. those who can complete data collection as required and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. combined with other endocrine diseases including obesity caused by endocrine disorders (such as Cushing's syndrome) 2. treatment with any drug within 90 days before screening may lead to significant weight changes - previous bariatric surgery (liposuction and / or abdominoplasty are allowed 1 year before screening) 3. pregnant or suspected pregnant or lactating women; 4. complicated with serious brain heart lung kidney blood system diseases mental diseases and infectious diseases; 5. acute infection such as acute cholecystitis appendicitis pancreatitis acute upper respiratory tract infection acute urinary system infection acute abdominal infection acute gastroenteritis (within 2 weeks). 6. history of acute myocardial infarction or stroke (within 6 months) 7. those who are participating in other interventional clinical trials or taking drugs with incompatibility with test drugs. 8. combined with active hepatitis B and C long-term heavy drinking (more than 14 drinking units per week on average) 9. long term use of non steroidal anti-inflammatory drugs glucocorticoids immunosuppressive drugs 10. chronic digestive inflammation such as Crohn's disease ulcerative colitis etc 11. autoimmune diseases and malignant tumors (within 2 years)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative weight change of patients before and after treatment (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in vitamins and trace elements;Biochemical function changes;Percentage change in subcutaneous fat/visceral fat area ratio;leptin;Change in waist circumference (cm);Changes in SF-36 Scale Score;Change in body weight (kg);Blood glucose changes;Impact of Weight on Quality of Life-Lite (IWQoL-Lite) score;Thyroid function;Changes in mental health assessed by PHQ-9 (Patient Health Questionnaire-9);Percentage change in visceral fat area (VTA);Change in waist-to-hip ratio;Change in body mass index (BMI);Glypican 4;zinc a2-glycoprotein;FK506-binding protein-like;Percentage of participants with weight loss =5% of baseline body weight;resistin;Number of new and ongoing nausea vomiting diarrhea and constipation events per week.;Blood pressure;Allergy testing;Percentage change in subcutaneous fat;Changes in tongue appearance;Lipid changes;interleukin 6 (IL-6);Percentage of participants with weight loss =10% of baseline body weight;Adherence to nutritional counseling;Percentage change in hepatic steatosis (Cap);tumor necrosis factor a (TNF-a);insulin-like growth factor 1 (IGF-1);Changes in blood routine + high-sensitivity C-reactive protein (hs-CRP);Changes in gut microbiota;Traditional Chinese medicine (TCM) syndrome scores;Changes in insulin-like growth factor binding proteins (IGFBPs);Changes in concomitant medications; | — |
Countries
China
Contacts
Public ContactYuqun Cai Haijun Huang
Zhejiang Provincial People's Hospital
Outcome results
None listed