A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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What is the Effects of Prokinetic Drug on the Blood Glucose in Type 2 Diabetes Patients: Mosapride Comparing Placebo

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Mosapride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age between 30-65 years old Type 2 diabetes Duration of diabetes less than 5 years and pancreatic function be in compensated stage. 7%≤HbA1C≤9% Patients are able to control diet and exercise by themselves in intervention period. Exclusion Criteria: Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications. Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors). Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt. Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. Fertile woman without contraceptives. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs. Allergic to or have contraindication to the intervention drugs.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mosapride<br>Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. | Drug: Mosapride<br>* Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.<br>|
| Placebo Comparator: Placebo<br>Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator. | Drug: Placebo<br>* Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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）] |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mosapride, blood glucose, serum lipid