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

Primary Purpose

Gastroparesis, Diabetes Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupoints combination 1
acupoints combination 2
sham acupoints combination
Sponsored by
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    acupoints combination 1

    acupoints combination 2

    sham acupoints combination

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    the score of GCSI
    GCSI means gastroparesis cardinal symptom index

    Secondary Outcome Measures

    Gastric emptying time
    gastrin concentrations
    motilin concentrations

    Full Information

    First Posted
    October 31, 2015
    Last Updated
    October 31, 2015
    Sponsor
    The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02594397
    Brief Title
    Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial
    Acronym
    ADG-RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroparesis, Diabetes Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    210 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    acupoints combination 1
    Arm Type
    Experimental
    Arm Description
    acupoints comination 1 includes the specific acupoint ST36 (Zusanli) and a local acupoint CV12 (Zhongwan).
    Arm Title
    acupoints combination 2
    Arm Type
    Active Comparator
    Arm Description
    acupoints comination 2 includes the specific acupoint ST36 (Zusanli) and a distal acupoint PC6(Neiguan).
    Arm Title
    sham acupoints combination
    Arm Type
    Sham Comparator
    Arm Description
    sham acupoints combination includes the specific acupoint ST36 (Zusanli) and a sham acupoint.
    Intervention Type
    Other
    Intervention Name(s)
    acupoints combination 1
    Intervention Type
    Other
    Intervention Name(s)
    acupoints combination 2
    Intervention Type
    Other
    Intervention Name(s)
    sham acupoints combination
    Primary Outcome Measure Information:
    Title
    the score of GCSI
    Description
    GCSI means gastroparesis cardinal symptom index
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Gastric emptying time
    Time Frame
    4 weeks
    Title
    gastrin concentrations
    Time Frame
    4 weeks
    Title
    motilin concentrations
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mailan Liu, Dr.
    Phone
    86-731-88458187
    Email
    445007305@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ping Li
    Email
    472198992@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zenghui Yue, Prof.
    Organizational Affiliation
    Hunan University of Chinese Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32399130
    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.
    Results Reference
    derived

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    Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial

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