Clinical trial NCT02594397: Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroparesis
Diabetes Complications
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: the score of GCSI
timeFrame: 4 weeks
Secondary outcomes:
measure: Gastric emptying time
timeFrame: 4 weeks
measure: gastrin concentrations
timeFrame: 4 weeks
measure: motilin concentrations
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hunan University of Chinese Medicine
name: Zenghui Yue, Prof.
role: STUDY_CHAIR
References:
citation: Xuefen W, Ping L, Li L, Xiaoli C, Yue Z. A Clinical Randomized Controlled Trial of Acupuncture Treatment of Gastroparesis Using Different Acupoints. Pain Res Manag. 2020 Apr 25;2020:8751958. doi: 10.1155/2020/8751958. eCollection 2020.