Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.

Detailed Description
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To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test. IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be oxidated to CO2.Patients eating food containing C13, and then collect their expired gas at 15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer, then can calculate the gastric emptying rate.

Official Title
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Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Drug: Mosapride
* Drug: domperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18≤ age ≤ 75 Patients coincided to, the WHO diagnostic criteria for diabetes in 1999 (namely have diabetes symptoms, plasma glucose tendency for 11.1 / L, at any time or fasting plasma glucose tendency for 7.0 / L, or oral glucose tolerance test 2 h plasma glucose levels tendency for 11.1 / L） fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L Be diagnosed diabetes more than 5 years, blood sugar steady in one month. have the following symptoms for over 4weeks: early satiety ,postprandial fullness ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain, constipation. Be diagnosed as Delayed Gastric Emptying by C13 breath test. Signed informed consent. Exclusion Criteria: take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other digestive disease. All patients will be administrated gastroscope in order to exclude stomach or duodenum disease, pyloric obstruction. It's normal in Liver, gallbladder, pancreas,spleen, nephridium by Ultrasound examination . Serious ketoacidosis. History of abdominal operation. Thyroid hypofunction or hyperthyroidism. nervous system disease or autoimmune diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mosapride<br>mosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days | Drug: Mosapride<br>* Mosapride 5mg by mouth ,3 times one day for 1 4days.<br>* Other names: Gasmotin;|
| Active Comparator: domperidone<br>domperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days | Drug: domperidone<br>* Domperidone 10mg by mouth ,3 times one day for 1 4days.<br>* Other names: Motilium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of gastric emptying time after taking the medicine | Gastric emptying time will be tested by C13 breath test. | 2 weeks |