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

October 31, 2015 updated by: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: acupoints combination 1
acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).
Other: acupoints combination 1
ACTIVE_COMPARATOR: acupoints combination 2
acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
Other: acupoints combination 2
SHAM_COMPARATOR: sham acupoints combination
sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
Other: sham acupoints combination

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastric emptying time
Time Frame: 4 weeks
4 weeks
gastrin concentrations
Time Frame: 4 weeks
4 weeks
motilin concentrations
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Investigators

  • Study Chair: Zenghui Yue, Prof., Hunan University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

October 31, 2015

First Submitted That Met QC Criteria

October 31, 2015

First Posted (ESTIMATE)

November 3, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2015

Last Update Submitted That Met QC Criteria

October 31, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014CB543102-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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