obese/overweight
Conditions
Interventions
trial group:Dietary and exercise management + Intragastic Superabsorbent Hydrogel Particles
control group:Diet and exercise management + placebo
Sponsors
Sun Yat-sen Memorid Hospital ,Sun Yat—sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 (inclusive) to 65 (inclusive), regardless of male or female; (2) Obese patients, i.e. patients with a BMI of 28 (inclusive) to 40 (inclusive); or overweight patients with at least 1 complication, i.e. patients with a BMI of 24 (inclusive) to 28 (exclusive) and any of the following complications: 1) Patients with hypertension (patients who were previously diagnosed with "hypertension" and are taking antihypertensive drugs or patients who meet the diagnostic criteria for hypertension (The office blood pressure is measured three times on different days, and all measured SBPs reach 140 or above and/or all measured DBPs reach 90mmHg or above.) specified in the 2023 Chinese Guidelines for the Management of Hypertension); 2) Patients with dyslipidemia (patients who were previously diagnosed with dyslipidemia and are taking lipid-lowering drugs, or patients who meet the diagnostic criteria for dyslipidemia (LDL-C: =4.1 mmol/L(160 mg/dl) and/or TG=2.3 mmol/L(200 mg/dl)) specified in the Chinese Guidelines for Lipid Management (2023) ); 3) Patients with prediabetes (patients who were previously diagnosed with prediabetes, or patients who meet the diagnostic criteria for prediabetes specified in the Intervention for Adults with Prediabetes: a Chinese Expert Consensus (2020 Edition)), and patients with type 2 diabetes who have not been treated or treated by Metformin (at a stable dose for at least 1 month (patients who were previously diagnosed with type 2 diabetes or patients who meet the diagnostic criteria for diabetes specified in the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 Edition)); (3) Patients who can understand the trial objectives, voluntarily participate in the trial and sign the ICF, and are able and willing to follow all requirements, including receiving follow-ups and evaluations.
Exclusion criteria
Exclusion criteria: (1) Patients with a weight change of over 3 kg within 3 months before the screening period; (2) Patients who have taken the drugs (including Chinese herbal medicines), health care products, meal replacements or other products that are known to possibly cause weight changes within 3 months before the screening period; (3) Patients who stopped smoking within 6 months before the screening period or patients who consider stopping smoking during the study; (4) Patients who are expected to receive surgical intervention during the study; (5) Patients with any of the following medical histories: A history of eating disorders (mild binge eating disorder (patients meeting the diagnostic criteria for binge eating disorder specified in the DSM-IV, i.e. patients with three or more of the following features: 1) Eating much more rapidly than normal; 2) Eating until feeling uncomfortably full; 3) Eating large amounts of food when not feeling physically hungry; 4) Eating alone because of being embarrassed by how much one is eating; 5) Feeling disgusted with oneself, depressed, or very guilty after overeating. There is binge eating at least 2 times a week within 6 months.) (excluding binge eating 3 times or below per week)), dysphagia, anatomic anomalies of the esophagus (e.g. webs, diverticula and rings), a history of erosive esophagitis or gastroesophageal reflux with complications, a history of stomach or duodenal ulcers with complications such as bleeding or perforation, a history of gastroparesis (chronic nausea, vomiting, heartburn, etc.), a history of pyloric obstruction, small intestinal diverticulum, a history of intestinal stenosis, Crohn disease, a history of intestinal obstruction or high risks of intestinal obstruction (including suspected adhesion of small intestine), a history of pancreatitis, a history of malabsorption, a history of abdominal radiotherapy, a history of RYGB or any other gastric surgery, and a history of small bowel resection (except appendectomy); (6) Patients with a medical history of Cushing syndrome; (7) Patients with thyroid dysfunction (FT3 and FT4 levels: decreased, or within their respective normal ranges, and TSH level: increased; FT3 and (or) FT4 level: increased, and TSH level: decreased; FT3 and FT4 levels: within their respective normal ranges, and TSH level: decreased), or patients who took antithyroid drugs or levothyroxine tablets within 1 month before the screening period; (8) Patients with AIDS, CHB, HCV, or a history of cancer within the past 5 years, or HBV carriers (patients tested positive for HBV DNA); (9) Patients with severe cardiac dysfunction (Class III/IV according to the NYHA heat function classification), abnormal liver function (ALT or AST = 3 times the ULN or TBIL = 2 times the ULN), renal dysfunction (GFR: eGFR<60 mL/min/1.73 m2, which is estimated according to the CKD-EPI formula (eGFR (ml/min/1.73 m2)=141×min(Scr/k, 1)a×max(Scr/k, 1) -1.209 × 0.993age × 1.018 (female) × 1.159 (black); k = 0.7 (female), 0.9 (male); a = -0.329 (female), -0.411 (male); Scr = serum creatinine, Unit mg/dL, 1 mg/dL=88.4 umol/L)); (10) Drug abusers or alcohol addicts or patients with uncontrollable mental illness; (11) Pregnant women or women having the plan for pregnancy, lactating patients, and women who may become pregnant without effective contraception; (12) Patients with angina, coronary bypass or myocardial infarction within 6 months before the screening period; (13) Patients with type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss percentage;proportion of subjects with a weight loss of 5 % or above; | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of subjects with a weight loss of 5 % or above;proportion of subjects with a weight loss of 10 % or above;BMI;Waist size;blood lipid (TC, TG, HDL and LDL-C) level ;FBG;FINS;HbA1c (for patient with type 2 diabetes) ;Blood pressure;IWQOL-Lite; | — |
Countries
China
Contacts
Public ContactLi Yan
Sun Yat-sen Memorid Hospital ,Sun Yat—sen University
Outcome results
None listed