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With the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mosapride | Active Comparator | Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. |
|
| Placebo | Placebo Comparator | Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosapride | Drug | Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of fasting plasma glucose (FPG,mmol/L) | Baseline, 24weeks (End of Trial) | |
| Change of OGTT 2 hour blood glucose(mmol/L) | Baseline, 24weeks (End of Trial) | |
| Change of HbA1c(%) | Baseline, 24weeks (End of Trial) | |
| Change of control rate of blood glucose(%) | Baseline, 24weeks (End of Trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of insulin release(uU/mL) | Baseline, 24weeks (End of Trial) | |
| Change of C peptide release(nmol/L) | Baseline, 24weeks (End of Trial) | |
| Change of HOMA-β[HOMA-β=20×(FINS,mIU/L)/((FPG,mmol/L)-3.5)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Zhiming, MD, PhD | Contact | 86-023-68767849 | zhuzm@yahoo.com | |
| Zhong Jian, MD | Contact | 86-023-68757883 | zhongjian2000@21cn.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhu Zhiming, MD, PhD | The third hospital affiliated to the Third Military Medical University. China | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C062720 | mosapride |
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| Placebo | Drug | Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. |
|
| Baseline, 24weeks (End of Trial) |
| Change of HOMA-IR [HOMA-IR=(FPG,mmol/L)×(FINS,mIU/L)/22.5] | Baseline, 24weeks (End of Trial) |
| Change of blood glucose variability(%) | Baseline, 24weeks (End of Trial) |
| Change of triglyceride(mmol/L) | Baseline, 24weeks (End of Trial) |
| Change of total cholesterol(mmol/L) | Baseline, 24weeks (End of Trial) |
| Change of LDL-c(mmol/L) | Baseline, 24weeks (End of Trial) |
| Change of HDL-c(mmol/L) | Baseline, 24weeks (End of Trial) |
| Change of Glucagon(pg/ml). | Baseline, 24weeks (End of Trial) |
| Change of GLP(pg/ml). | Baseline, 24weeks (End of Trial) |
| Change of GIP(pg/ml). | Baseline, 24weeks (End of Trial) |
| Change of DPP-IV(pg/ml). | Baseline, 24weeks (End of Trial) |
| Change of waist circumference (WC,cm) | Baseline, 24weeks (End of Trial) |
| Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2) | Baseline, 24weeks (End of Trial) |
| Change of body fat(%). | Baseline, 24weeks (End of Trial) |
| Change of carotid intima-media thickness (IMT,mm). | Baseline, 24weeks (End of Trial) |
| Change of 24-hours urine sodium(mmol/24h) | Baseline, 24weeks (End of Trial) |
| Change of 24-hours microalbumin(mg/L). | Baseline, 24weeks (End of Trial) |
| Change of 24-hours mALB/Cr(mg/g.Cr). | Baseline, 24weeks (End of Trial) |
| Change of inflammatory markers(hs-CRP,mg/L). | Baseline, 24weeks (End of Trial) |
| Incidence rate of newly-diagnosed hypertension(%). | Baseline, 24weeks (End of Trial) |
| Heart rate variability(HRV,%). | Baseline, 24weeks (End of Trial) |
| Change of clinic blood pressure and 24h mean blood pressure(mmHg). | Baseline, 24weeks (End of Trial) |
| D004700 | Endocrine System Diseases |