Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.
Participants will be randomized into either group. One group will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks. The other group dosage regime depends on the tolerance of the semaglutide from participants. The dosage will stabilize on the dose how much participant could tolerate. At the end of 16 weeks treatment, comparison will be carried out on weight change before and after treatment and (1) Comparison of different administration methods (standards and titrations) on participant compliance, appetite and quality of life improvement; (2) Comparison of metabolism (waist hip circumference, body fat and body composition, blood pressure, blood lipid, blood glucose, insulin resistance) in different administration modes; (3) Comparison of adverse reactions of metabolic drugs in different administration modes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard arm | Active Comparator | standard arm will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks.. |
|
| titration arm | Active Comparator | Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | treatment with different dosage regimes |
|
| Measure | Description | Time Frame |
|---|---|---|
| weight change in kilograms | weight change in kilograms before and after treatment | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| patient compliance in rate | rate of participants dropout of the study(in percentage) | 16 weeks |
| waist hip circumference in centimeter | waist hip circumference in centimeter |
Not provided
Inclusion Criteria:
18 ≤ age<75;
Overweight or obesity: meet either one of the following standards
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaolong zhao | Contact | 86-13501827230 | xiaolongzhao@163.com | |
| xiaolong zhao | Contact | 86-021-37990333 |
| Name | Affiliation | Role |
|---|---|---|
| xiaolong zhao | Shanghai Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34097869 | Background | Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4. | |
| 10702749 | Background | Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 16 weeks |
| number of adverse events | number of adverse events including hypoglycemia, nausea, vomiting, abdominal pain, diarrhea, constipation, indigestion, burping, flatulence, injection site allergy. Adverse reactions will recorded in percentage (number of participants developed particular adverse reaction divided by all participants in each group, % ) | 16 weeks |
| appetite change in score | appetite change measures in appetite questionnaire (visual analogue scales in assessment of appetite sensations, Units on scale is millimeter) | 16 weeks |
| quality of life improvement in score | quality of life improvement (in WHOQOL~BREF, Units on scale is point); | 16 weeks |
| body fat in percentage | body fat in percentage | 16 weeks |
| body composition of lean mass in kilogram | body composition in kilogram of lean mass | 16 weeks |
| blood pressure in mmHg | blood pressure in mmHg | 16 weeks |
| blood lipid in concentration | blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L), | 16 weeks |
| fasting blood glucose level | fasting blood glucose in milli-mole per liter | 16 weeks |
| HOMA-Beta value | the value of 20 × FINS/(FBG-3.5) | 16 weeks |
| total cholesterol in mmol/L | total cholesterolin mmol/L | 16 weeks |
| triglyceride | triglyceride in mmol/L | 16 weeks |
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol in mmol/L | 16 weeks |
| high-density lipoprotein cholesterol | high-density lipoprotein cholesterol in mmol/L | 16 weeks |
| 28266779 | Background | Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, Hjerpsted JB. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab. 2017 Sep;19(9):1242-1251. doi: 10.1111/dom.12932. Epub 2017 May 5. |