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| Name | Class |
|---|---|
| Chinese Medical Association | NETWORK |
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The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .
Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.
Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standarddose Saxagliptin | Experimental | Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months |
|
| Lifestyle intervention | Active Comparator | Lifestyle intervention for 6 months |
|
| Metformin | Active Comparator | Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months |
|
| low dose Saxagliptin | Experimental | Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 5mg a day for 6 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| oral glucose tolerance test | Change of Blood sugar from baseline at 6 months |
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Inclusion Criteria:
1.Newly diagnosed insulin resistance or glucose intolerance .
2.20 to 70 years of age.
3.BMI≥28kg/m2,or BMI>25kg/m2 beside waistline≥80cm(female),≥90cm(male).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinli Zhou, MD,PhD | Contact | 15168889976 | zhouxinli0301@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinli Zhou, MD, PhD | Shandong Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28575729 | Derived | Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| saxagliptin | Drug | 2.5 mg a day for 6 months |
|
|
| metformin | Drug | 500mg three times a day for 6 months |
|
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| lifestyle intervention | Other | lifestyle intervention for 6 months |
|
|
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |