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This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.
This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.
Screening will be made to select eligible participants before intervention. Patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. Lifestyle interventions will be maintained during the treatment period. Subjects are followed up every 4 weeks for examinations.At the end of the study, data will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin Hydrochloride Tablet 500mg po by month,three times a day for 12 weeks |
|
| Benaglutide | Active Comparator | Benaglutide Injection 0.2mg, iH,po, three times a day for 3 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 2-week dose adjustment period(0-2weeks)[before meals] 0-2d: - ;250mg,po; -. 3-4d: - ;250mg,po; 250mg,po. 5-6d: 250mg,po; 250mg,po; 250mg,po. 7-9d: 250mg,po; 500mg,po; 250mg,po. 10-11d: 250mg,po; 500mg,po; 500mg,po. 12-14d: 500mg,po; 500mg,po; 500mg,po. 10-week dose stabilization period(3-12weeks) Metformin Hydrochloride Tablet 500mg tid po. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention. | Change from Baseline after 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body mass index (BMI) of subjects | All 30 subjects of each group would be evaluted by changes in body mass index (BMI) after 12 weeks treatment | Change from Baseline after 12 weeks treatment |
| Changes in Body Fat Levels |
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Inclusion Criteria:
(1)20 years old≤70 years old; (2) simple obesity, gender is not limited; (3) 28.0≤BMI≤37.5kg/m2; (4) Before the screening period, the body weight was controlled by lifestyle interventions (diet and exercise) for at least 3 months, and weight was decreased by <5% from baseline; (5) Agree to sign the informed consent form;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalong Zhu, MD,PhD | Contact | 86-25-83-105302 | zhudldr@gmail.com | |
| Yan Bi, MD,PhD | Contact | 86-25-83-105302 | biyan@nju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD,PhD | the Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Benaglutide | Drug | 2-week dose adjustment period(0-2weeks) [before meals] 0-2d: -; 0.1mg,iH; -; 3-4d: -; 0.1mg,iH; 0.1mg,iH; 5-6d: 0.1mg,iH; 0.1mg,iH; 0.1mg,iH; 7-9d: 0.1mg,iH; 0.2mg,iH; 0.1mg,iH; 10-11d: 0.1mg,iH; 0.2mg,iH; 0.2mg,iH; 12-14d: 0.2mg,iH; 0.2mg,iH; 0.2mg,iH. 10-week dose stabilization period(3-12weeks) Benaglutide Injection 0.2mg,100ul,tid,iH |
|
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Changes in Body Fat Levels from Baseline: Body Composition Analysis
| Change from Baseline after 12 weeks treatment |
| Changes in blood lipid levels | The changes in blood lipid levels such as cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein will be measured at the beginning and the end. | Change from Baseline after 12 weeks treatment |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |