Clinical trial NCT02606617: A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes
Official title: What is the Effects of Prokinetic Drug on the Blood Glucose in Type 2 Diabetes Patients: Mosapride Comparing Placebo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Mosapride
blood glucose
serum lipid
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of fasting plasma glucose (FPG,mmol/L)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of OGTT 2 hour blood glucose(mmol/L)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of HbA1c(%)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of control rate of blood glucose(%)
timeFrame: Baseline, 24weeks (End of Trial)
Secondary outcomes:
measure: Change of insulin release(uU/mL)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of C peptide release(nmol/L)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of HOMA-β[HOMA-β=20×（FINS,mIU/L）/（（FPG,mmol/L）-3.5）]
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of HOMA-IR [HOMA-IR=(FPG,mmol/L）×（FINS,mIU/L）/22.5]
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of blood glucose variability(%)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of triglyceride(mmol/L）
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of total cholesterol(mmol/L）
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of LDL-c(mmol/L）
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of HDL-c(mmol/L）
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of Glucagon(pg/ml).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of GLP(pg/ml).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of GIP(pg/ml).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of DPP-IV(pg/ml).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of waist circumference (WC,cm)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of body fat(%).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of carotid intima-media thickness (IMT,mm).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of 24-hours urine sodium(mmol/24h)
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of 24-hours microalbumin(mg/L).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of 24-hours mALB/Cr(mg/g.Cr).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of inflammatory markers(hs-CRP,mg/L).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Incidence rate of newly-diagnosed hypertension(%).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Heart rate variability(HRV,%).
timeFrame: Baseline, 24weeks (End of Trial)
measure: Change of clinic blood pressure and 24h mean blood pressure(mmHg).
timeFrame: Baseline, 24weeks (End of Trial)
Other outcomes:
Locations:
Study officials:
affiliation: The third hospital affiliated to the Third Military Medical University. China
name: Zhu Zhiming, MD, PhD
role: STUDY_DIRECTOR
References: