obesity
Conditions
Interventions
control group (The energy-restricted group):A balanced, energy-restricted diet with an energy intake reduced by 500 kcal per day
Experimental group 1:Energy-restricted and polyethylene glycol loxenatide
Experimental group 2:Energy-restricted and whey protein
Experimental group 3:Energy-restricted and polyethylene glycol loxenatide and whey protein
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Age >18 and = 28 kg/m2 (3) A body weight change of <= 5% within the 3 months prior to screening, calculated as [(maximum body weight - minimum body weight)/maximum body weight × 100%], based on self-reported data from the subject. (4)Signed the informed consent form and agreed to adhere strictly to the requirements and restrictions outlined in the informed consent form and study protocol throughout the study. This includes, but is not limited to, adherence to diet, exercise, and lifestyle management, proper use of study drugs as prescribed, and the completion of relevant questionnaires.
Exclusion criteria
Exclusion criteria: (1)Meet any of the following criteria: (a) HbA1c >= 6.5% or fasting venous blood glucose >= 7.0 mmol/L at screening; (b) a history of type 1, type 2, or other specific types of diabetes. (2)Obesity resulting from medications or diseases (e.g., Cushing's syndrome, acromegaly, hypothyroidism); or weight gain due to an increase in non-fat components (e.g., edema). (3)Use of slimming pills or alternative therapies within 3 months prior to screening, including but not limited to GLP-1 agonists, Orlistat, Sibutramine hydrochloride, phenylpropanolamine,Mazindol, phenbutamine, lorcaserin hydrochloride, phentermine, phentermine/topiramate mixture, amfepramone, and naltrexone/bupropion mixture. (4)Use of drugs that may cause significant weight gain within 3 months prior to screening, including but not limited to tricyclic antidepressants, psychiatric medications, or sedatives such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, and lithium salts. (5)History of undergoing bariatric metabolic surgery. (6)Subjects who have received chronic systemic glucocorticoid treatment for more than 2 weeks (excluding topical, intraocular, intranasal, and inhaled administration) within 3 months before screening,or those whom the investigators believe may require systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled administration) within the next year. (7)Presence of severe gastrointestinal diseases, such as abnormal gastric emptying or inflammatory bowel disease. (8)Moderate to severe depression or other serious mental illnesses, such as schizophrenia, bipolar disorder, or other significant mood or anxiety disorders, or any other mental conditions that the investigator deems unsuitable for participation in this study. (9)Meeting any of the following criteria during screening: (a) systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg; (b) eGFR 3 times the upper limit of normal; (d) blood amylase or lipase levels > 1.5 times the upper limit of normal; (e) blood triglycerides > 5.7 mmol/L; (f) calcitonin levels >= 50 ng/L (pg/mL). (10)A history of dairy allergy or lactose intolerance. (11)Diagnosis of malignant tumors within 5 years prior to screening, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. (12)Female subjects of childbearing potential who are pregnant or lactating at the time of screening, or male or female subjects of childbearing potential and their partners who are unable to use effective contraceptive measures during the trial and for 3 months after the completion of treatment. (13)A personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). (14)A history of any of the following major cardiovascular or cerebrovascular conditions within 180 days prior to screening: myocardial infarction, coronary artery angioplasty or bypass surgery, valvular heart disease or heart valve repair, clinically significant arrhythmias requiring treatment, unstable angina, decompensated heart failure (NYHA Class III or IV), transient ischemic attack, or cerebrovascular accident. (15)The presence of any of the following conditions prior to or during screening: chronic pancreatitis, acute pancreatitis, symptomatic gallbladder disease (excluding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| skeletal muscle mass;body fat mass;body fat percentage;glycated haemoglobin A1c (HbA1c);glucose tolerance;insulin;liver function markers(ALT, AST, ?-GT);lipids (TC, TG, HDL, LDL, apoA);uric acid;hypersensitive C-reactive protein;adiponectin;free fatty acid;waist circumference;hip circumference;Body Mass Index;blood pressure;hepatic steatosis severity; | — |
Countries
China
Contacts
Public ContactTao Yang
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed