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

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Mosapride

• Registration Number: NCT02606617
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-25
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-15
• Last Update Submitted: 2015-11-15
• Study First Posted: 2015-11-17
• Last Update Posted: 2015-11-17
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Mosapride	Mosapride	Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

Primary Outcome Measures

Name	Time	Method
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 control rate of blood glucose(%)	Baseline, 24weeks (End of Trial)
Change of HbA1c(%)	Baseline, 24weeks (End of Trial)

Secondary Outcome Measures

Name	Time	Method
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 DPP-IV(pg/ml).	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 carotid intima-media thickness (IMT,mm).	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 GLP(pg/ml).	Baseline, 24weeks (End of Trial)
Change of GIP(pg/ml).	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 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)