Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial (ADG-RCT)

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Diabetes Complications; Gastroparesis

Treatments: Other: acupoints combination 2; Other: acupoints combination 1; Other: sham acupoints combination

Study type: Interventional

Funder types: Other

Identifiers

NCT02594397

2014CB543102-2

Details and patient eligibility

About

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

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

acupoints combination 1

Experimental group

Description:

acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).

Treatment:

Other: acupoints combination 1

acupoints combination 2

Active Comparator group

Description:

acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).

Treatment:

Other: acupoints combination 2

sham acupoints combination

Sham Comparator group

Description:

sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.

Treatment:

Other: sham acupoints combination