Overweight or obese
Conditions
Interventions
Experimental group:Dietary and exercise guidance+Stomach volume occupying capsules
Control group:Dietary and exercise guidance+Placebo
Sponsors
Peking Universit First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily participate in the experiment and sign an informed consent form; 2) The subjects are aged between 18 and 60 years old, regardless of gender; 3) 24kg/m2 = Body Mass Index (BMI) = 40kg/m2; 4) Able to communicate well with researchers and comply with experimental requirements.
Exclusion criteria
Exclusion criteria: 1) Weight loss exceeding 4.5kg within the past 3 months, or taking weight loss medication within the past 1 month; 2) Drugs that may lead to significant weight gain have been used in the past month, including systemic glucocorticoid treatment (lasting for more than one week), antipsychotic or antidepressant drugs, traditional Chinese patent medicines and simple preparations and Chinese herbal medicine; 3) Subjects definitely diagnosed as type 1 diabetes; 4) Breastfeeding, pregnant women, subjects who plan to conceive during the trial period, or subjects of childbearing age who have not yet taken effective contraceptive measures; 5) Have a history of eating disorders (excluding mild eating disorders); 6) Subjects with a history of severe gastrointestinal diseases, gastric bypass, or other gastrointestinal surgeries; 7) Glycated hemoglobin (HbA1c)>8.5% (>69mmol/mol) or fasting blood glucose (FPG)>8mmol/L (145mg/dL); 8) Severe heart, liver, brain, kidney diseases or systemic failure affecting treatment; 9) Poor control of hypertension [systolic blood pressure (SBP)>165 mmHg and/or diastolic blood pressure (DBP)>95 mmHg]; 10) Those who take hypoglycemic drugs other than metformin (with a stable dose for three months); 11) Those who have a history of alcoholism or have consumed more than 28 units of alcohol per week in the past 2 weeks (1 unit=285mL of beer, 25mL of spirits, or 150mL of wine); 12) Individuals with a history of endocrine diseases that can cause weight changes, such as Cushing's syndrome, thyroid function disorders, polycystic ovary disease, or other genetic endocrine diseases; 13) Individuals with concomitant central nervous system diseases (including but not limited to any type of epilepsy or stroke) and other related nervous system diseases or mental disorders; 14) Individuals with a history of allergies to citric acid, cellulose, sodium stearate fumarate, polyethylene glycol, gelatin, or titanium dioxide; 15) Subjects who have participated in clinical trials of other drugs or medical devices within the past 3 months; 16) Any other subjects deemed unsuitable by the researchers for participation in this experiment. For example: esophageal diverticulum; Gastroesophageal reflux; Malignant tumors within 5 years; Active hepatitis; Unstable angina, coronary artery bypass grafting, myocardial infarction, and other diseases within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss response rate in the 24th week;Percentage of weight loss from baseline at week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of weight loss from baseline at week 12; Changes in waist circumference from baseline at weeks 12 and 24;Changes in blood lipid profile from baseline at weeks 12 and 24; Change in Quality of Life Scale Scores from Baseline at Week 12 and Week 24;The occurrence of other adverse events during the study period;Changes in fasting blood glucose and insulin from baseline at weeks 12 and 24 after enrollment;Change value of glycosylated hemoglobin (HbA1c) from baseline in subjects with type 2 diabetes at the 12th and 24th weeks after enrollment; | — |
Countries
China
Contacts
Public ContactGuo Xiaohui
Peking University First Hospital
Outcome results
None listed