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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02606617
• Other study ID #: PDBG
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 25, 2015
• Last updated: November 15, 2015
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Third Military Medical University
• Contact: Zhu Zhiming, MD, PhD
• Phone: 86-023-68767849
• Email: zhuzm[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Mosapride
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
• Placebo
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of fasting plasma glucose (FPG,mmol/L)		Baseline, 24weeks (End of Trial)	No
Primary	Change of OGTT 2 hour blood glucose(mmol/L)		Baseline, 24weeks (End of Trial)	No
Primary	Change of HbA1c(%)		Baseline, 24weeks (End of Trial)	No
Primary	Change of control rate of blood glucose(%)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of insulin release(uU/mL)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of C peptide release(nmol/L)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of HOMA-ß[HOMA-ß=20×(FINS,mIU/L)/((FPG,mmol/L)-3.5)]		Baseline, 24weeks (End of Trial)	No
Secondary	Change of HOMA-IR [HOMA-IR=(FPG,mmol/L)×(FINS,mIU/L)/22.5]		Baseline, 24weeks (End of Trial)	No
Secondary	Change of blood glucose variability(%)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of triglyceride(mmol/L)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of total cholesterol(mmol/L)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of LDL-c(mmol/L)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of HDL-c(mmol/L)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of Glucagon(pg/ml).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of GLP(pg/ml).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of GIP(pg/ml).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of DPP-IV(pg/ml).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of waist circumference (WC,cm)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of body fat(%).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of carotid intima-media thickness (IMT,mm).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of 24-hours urine sodium(mmol/24h)		Baseline, 24weeks (End of Trial)	No
Secondary	Change of 24-hours microalbumin(mg/L).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of 24-hours mALB/Cr(mg/g.Cr).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of inflammatory markers(hs-CRP,mg/L).		Baseline, 24weeks (End of Trial)	No
Secondary	Incidence rate of newly-diagnosed hypertension(%).		Baseline, 24weeks (End of Trial)	No
Secondary	Heart rate variability(HRV,%).		Baseline, 24weeks (End of Trial)	No
Secondary	Change of clinic blood pressure and 24h mean blood pressure(mmHg).		Baseline, 24weeks (End of Trial)	No