overweight/obesity
Conditions
Interventions
contro group:Health education only
Intervention group:behavioral interventions
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years 2. BMI >=30 kg/m², or 27 kg/m² < =BMI <30 kg/m² with at least 1 weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea, etc.) 3. Currently treated with simethicone 1.0 mg/week subcutaneously who are willing and clinically assessed to be suitable for the current simethicone 1.0 mg/week subcutaneous regimen with a range of fluctuations of <= +/- 0.1 mg per week, completing the 24-week study 4. have no plans to move out in the next 1 year 5. Agree to sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Glucose metabolism related: (1) Glycosylated haemoglobin >= 6.5%; (2) History of diabetes or taking glucose-lowering medications; (3) Taking glucose-lowering medications other than simethicone within 90 days prior to screening; 2. Uncontrolled thyroid disease (1) Abnormal thyroid function: thyrotropin TSH > 6.0 or 5kg in the 90 days prior to screening; (2) Have used any medication other than simethicone to reduce weight within 90 days prior to screening; (3) Have had or plan to have weight loss treatment via surgery during the trial; (4) Use of medications that affect the metabolism of EDCs (e.g., rifampicin, etc.) within the last 3 months (5) Clinically suspected or diagnosed secondary causes of obesity such as Cushing's syndrome; 4. Mental health: (1) History of major depression within 2 years prior to screening; (2) Diagnosis of other serious mental illness (e.g., schizophrenia, bipolar disorder); (3) Depression Questionnaire (PHQ-9) score >=15 at screening; (4) Suicidal behaviour within 30 days prior to screening; 5. General safety-related: (1) Participants' inability to comply with behavioural interventions as judged by the investigator; (2) History of acute pancreatitis and chronic pancreatitis 180 days prior; (3) Personal or first-degree relative history of multiple endocrine adenomas or medullary thyroid carcinoma; (4) Self-reported history of severe gastrointestinal disease or history of gastrointestinal surgery within the past 12 months; (5) Estimated glomerular filtration rate eGFR <15 mL/min/1.73m^2; (6) History of malignancy within 5 years prior to screening; (7) Myocardial infarction, unstable angina or cerebral infarction, or transient ischaemic attack within 60 days prior to screening; (8) Known or suspected alcohol abuse; smoker or current smoker within 3 months prior to baseline survey; (9) Participation in another clinical trial within 90 days prior to screening; (10) Women who are pregnant, breastfeeding or preparing for pregnancy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight change;change in body fat percentage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hip Circumference;Waist Circumference;Muscle Mass;lipid profile;HbA1c;fasting blood glucose;insulin;subcutaneous fat thickness; | — |
Countries
China
Contacts
Public ContactYan Xing
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed