What is the Effects of Prokinetic Drug on the Blood Glucose in Type 2 Diabetes Patients: Mosapride Comparing Placebo
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- Change of fasting plasma glucose (FPG,mmol/L)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mosapride
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
干预措施: Mosapride (Drug)
Placebo
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of fasting plasma glucose (FPG,mmol/L)
时间窗: Baseline, 24weeks (End of Trial)
Change of OGTT 2 hour blood glucose(mmol/L)
时间窗: Baseline, 24weeks (End of Trial)
Change of control rate of blood glucose(%)
时间窗: Baseline, 24weeks (End of Trial)
Change of HbA1c(%)
时间窗: Baseline, 24weeks (End of Trial)
次要结局
- Change of GIP(pg/ml).(Baseline, 24weeks (End of Trial))
- Change of DPP-IV(pg/ml).(Baseline, 24weeks (End of Trial))
- Change of GLP(pg/ml).(Baseline, 24weeks (End of Trial))
- 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-IR [HOMA-IR=(FPG,mmol/L）×（FINS,mIU/L）/22.5](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 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 24-hours urine sodium(mmol/24h)(Baseline, 24weeks (End of Trial))
- Change of waist circumference (WC,cm)(Baseline, 24weeks (End of Trial))
- Change of body fat(%).(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 carotid intima-media thickness (IMT,mm).(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))
研究者
Zhiming Zhu
MD, PhD
Third Military Medical University