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The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benaglutide | Experimental | Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal. |
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| Liraglutide | Active Comparator | Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benaglutide | Drug | The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change at 3 months | Measured in kilograms | baseline and 3 months |
| Gut microbiota composition | Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Measured in cm | baseline and 3 months |
| Change in systolic blood pressure | Measured in mmHg | baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Wu | Contact | +8613574120508 | wujing0731@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Wu | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | 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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Liraglutide | Drug | The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day. |
|
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| Change in diastolic blood pressure | Measured in mmHg | baseline and 3 months |
| Change in HbA1c | Measured in % | baseline and 3 months |
| Change in plasma glucose | Measured in mmol/l | baseline and 3 months |
| Change in insulin | Measured in μU/ml | baseline and 3 months |
| Change in lipids-total cholesterol | Measured in mmol/l | baseline and 3 months |
| Change in lipids-low density lipoprotein cholesterol | Measured in mmol/l | baseline and 3 months |
| Change in lipids-high density lipoprotein cholesterol | Measured in mmol/l | baseline and 3 months |
| Change in lipids-triglycerides | Measured in mmol/l | baseline and 3 months |
| Change in lipids-free fatty acids | Measured in μmol/l | baseline and 3 months |
| Change in Uric Acid | Measured in mmol/l | baseline and 3 months |
| Change in interleukin-10 | Measured in mmol/l | baseline and 3 months |
| Change in tumor necrosis factor | Measured in mmol/l | baseline and 3 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |