Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial

Not Applicable

• Conditions: Gastroparesis; Diabetes Complications
• Interventions: Other: sham acupoints combination; Other: acupoints combination 2; Other: acupoints combination 1

• Registration Number: NCT02594397
• Lead Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-10-31
• Study First Submitted QC: 2015-10-31
• Last Update Submitted: 2015-10-31
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Study Start: 2015-12
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham acupoints combination	sham acupoints combination	sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
acupoints combination 2	acupoints combination 2	acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
acupoints combination 1	acupoints combination 1	acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).

Primary Outcome Measures

Name	Time	Method
the score of GCSI	4 weeks	GCSI means gastroparesis cardinal symptom index

Secondary Outcome Measures

Name	Time	Method
gastrin concentrations	4 weeks
motilin concentrations	4 weeks
Gastric emptying time	4 weeks