Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.

Conditions
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Gastroparesis, Diabetes Complications

Intervention / Treatment
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* Other: acupoints combination 1
* Other: acupoints combination 2
* Other: sham acupoints combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals who meet the diagnostic criteria of diabetes gastric paralysis. individuals between the ages of 18 and 60 years. individuals who meet blood glucose control standards: Fasting plasma glucose (FPG) ≤7. 8mmol/L; 2 hours plasma glucose (2hPG)≤13.6mmol/L. individuals who suffered for more than 3 years. individuals who treated with diet control or exercise or using hypoglycemic drug (except for α-glucosidase Inhibitor) on the basis of diet or exercise therapy and the dose stability must be last at least 3 months. individuals who receive no other treatments in the first 3 months. women who is at the age of childbearing age and take contraceptive measures. individuals who voluntarily agree with a study protocol and sign a written informed consent. Exclusion Criteria: individuals who have reflux esophagitis; individuals who have gastroparesis after surgery; individuals who have acute complications with ketoacidosis and nonketotic hyperosmolar coma; individuals who have Acute cardiovascular and cerebrovascular diseases or Severe trauma or surgery, severe infection. Or who are pregnant or breastfeeding; individuals who have a history disease of myocardial infarction, acute coronary syndrome or coronary revascularization; individuals who have serious hepatobiliary disease, or AST and/or ALT 2 times greater than the upper limit of normal patients; individuals with kidney damage, and serum creatinine exceeds 140umol/L; individuals who have obvious blood system diseases (Any one of which can not be caught in line: Hb: male<110g/L, women<100g/L,WBC<3.5×109/L,PLT<80×109/L). individuals who have a problem of blood press:SBP≥180mmHg,DPB≥100mmHg; individuals who have cancer or other serious progressive wasting disease, and easy to infection and bleeding; individuals who have peptic ulcer or other organic disease confirmed by esophagogastroduodenoscopy; individuals unwilling to meet the testing and exacerbations,or have serious complications in the test; individuals who have taking α-glucosidase inhibitor drug in the past four weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupoints combination 1<br>acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan). | Other: acupoints combination 1<br> <br> |
| Active Comparator: acupoints combination 2<br>acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan). | Other: acupoints combination 2<br> <br> |
| Sham Comparator: sham acupoints combination<br>sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint. | Other: sham acupoints combination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the score of GCSI | GCSI means gastroparesis cardinal symptom index | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time |  | 4 weeks | 
| gastrin concentrations |  | 4 weeks | 
| motilin concentrations |  | 4 weeks |