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

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Mosapride

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mosapride, blood glucose, serum lipid

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mosapride

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of fasting plasma glucose (FPG,mmol/L)

Change of OGTT 2 hour blood glucose(mmol/L)

Change of HbA1c(%)

Change of control rate of blood glucose(%)

Secondary Outcome Measures

Change of insulin release(uU/mL)

Change of C peptide release(nmol/L)

Change of HOMA-β[HOMA-β=20×（FINS,mIU/L）/（（FPG,mmol/L）-3.5）]

Change of HOMA-IR [HOMA-IR=(FPG,mmol/L）×（FINS,mIU/L）/22.5]

Change of blood glucose variability(%)

Change of triglyceride(mmol/L）

Change of total cholesterol(mmol/L）

Change of LDL-c(mmol/L）

Change of HDL-c(mmol/L）

Change of Glucagon(pg/ml).

Change of GLP(pg/ml).

Change of GIP(pg/ml).

Change of DPP-IV(pg/ml).

Change of waist circumference (WC,cm)

Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2)

Change of body fat(%).

Change of carotid intima-media thickness (IMT,mm).

Change of 24-hours urine sodium(mmol/24h)

Change of 24-hours microalbumin(mg/L).

Change of 24-hours mALB/Cr(mg/g.Cr).

Change of inflammatory markers(hs-CRP,mg/L).

Incidence rate of newly-diagnosed hypertension(%).

Heart rate variability(HRV,%).

Change of clinic blood pressure and 24h mean blood pressure(mmHg).

Full Information

NCT ID

NCT02606617

First Posted

October 25, 2015

Last Updated

November 15, 2015

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02606617

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Mosapride, blood glucose, serum lipid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mosapride

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mosapride

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of fasting plasma glucose (FPG,mmol/L)

Time Frame