Obesity
Conditions
Interventions
Intermittent fasting group:The intermittent fasting diet uses a 5:2 diet plan that includes 2 fasting days (500 calories per day) and 5 eating days. Fasting days can occur on two consecutive or non-co
Smegglutide group:Participants received subcutaneous administration of 1.0mg semaglutide once a week for 12 weeks on a diet restricted basis
Sponsors
Shanghai Tongren Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Age between 25 and 50 (including the critical value), both male and female; 2) Overweight or obese patients (BMI=25.0 kg/m2 and BMI=35.0kg/m2); 3) With or without other obesity-related metabolic complications, such as hypertension, dyslipidemia, hyperuricemia, etc.; 4) HbA1c = 6.5% during the screening period, and at the same time, the fasting blood glucose value on the day of screening = 6.1mmol/L and the 2-hour postprandial blood glucose = 11.1mmol/L; 5) Have not used traditional Chinese medicine and western medicine to control weight within 6 months; 6) Learn more about the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial; understand the research procedure and voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Suffering from diabetes, including (type 1 diabetes, type 2 diabetes, single gene mutation diabetes, diabetes caused by pancreatic damage or other secondary diabetes); 2) Evidence of hyperandrogenism or polycystic ovary syndrome; 3) Known clinically significant abnormal gastric emptying, acute and chronic pancreatitis 4) Those with other serious structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA=III grade), or receiving interventional therapy or Those who have used cardiac stents, or those with stage III hypertension (the systolic blood pressure cannot be controlled below 160mmHg with three antihypertensive drugs); 5. Have treated or untreated organ system tumors (except local skin basal cell carcinoma) within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis; 6) People with gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active peptic ulcer, acute cholecystitis, etc.) 7) Severe diarrhea refers to 3 or more watery stools per day and lasts for 3 days or more, and severe constipation refers to 2 or less bowel movements per week, accompanied by difficulty in defecation; 8) There are any hematological diseases that may interfere with the measurement of HbA1c, and those with severe infection, severe anemia, and neutropenia; 9) Have a history of intestinal segment resection, or have received other gastrointestinal surgery (such as cholecystectomy) within 1 year before screening, or have received other non-gastrointestinal surgery within six months; 10) Neuropsychiatric abnormalities or history of drug abuse; 11) Within 3 months before admission or planned to use weight control drugs (including weight loss drugs), corticosteroids and other hormone drugs (including oral, intramuscular injection or intravenous systemic administration, parenteral administration or intraarticular administration) medicine); 12) Severe liver and kidney dysfunction, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 × ULN, serum creatinine > ULN, glomerular filtration rate (eGFR) at screening 40 g/day, alcohol intake for women > 20 g/day, 40 g of alcohol is about 1000 mL of beer (6 degrees), or 500 mL of red wine or rice wine (12 degrees), or 100mL liquor (50 degrees)); 15) Pregnant and lactating women; 16) Any situation that the researcher thinks is inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss rate during intervention period;Weight change rate during drug withdrawal observation period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood lipids;Visceral and subcutaneous fat area;Liver fat content;Gut flora; | — |
Countries
China
Contacts
Public ContactShan Huang
Shanghai Tongren Hospital
Outcome results
None listed