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The sponsor decides withdrawn this study.
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This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.
Background:The rapid growth of obese or overweight people in the world has become a major social problem. Obese often associated with kinds of metabolic disorders, especially type 2 diabetes, and Liraglutide can effectively reduce weight and improve blood glucose.Previous studies have indicated that most patients will experience different degrees of weight loss after using Liraglutide, but there is also a small number of patients with no significant weight loss.The gene polymorphism among individuals may affect the weight loss effect of Liraglutide.
Objectives:1.To find the relationships between genetic variants and the response of Liraglutide to treatment of obese patients.2.To investigate the effects of Liraglutide on weight, metabolism (blood glucose, blood lipid, uric acid, etc.) and gut microbiota in obese Chinese patients.
Intervention:Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | Obese patients with HbA1C lower than 9.0%,receive Liraglutide alone for 3 months. |
|
| Liraglutide combined with metformin | Experimental | Obese patients with HbA1C ≥9.0%, receive Liraglutide in combination with metformin for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards,1.8mg per day, subcutaneous injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change at 3 months | Measured in kilograms | baseline and 3 months |
| Genotype | baseline |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | 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;metformin | Drug | The treatment of Liraglutide combined with metformin lasted three months.For Liraglutide,during the first week: 0.6mg per day, subcutaneous injection;during the second week: 1.2mg per day, subcutaneous injection; from third week onwards,1.8mg per day, subcutaneous injection.For metformin,during three months:0.5g each time, 3 times per day,oral. |
|
|
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |