Diabetic GastroparesisPhase 1NCT02452489
Different Acupoints Compatibility Difference of the Effect of Treatment of the Diabetic Gastroparesis
A Phase 1 study testing acupuncture in people with Diabetic Gastroparesis, run by Changchun University of Chinese Medicine at 1 site in China.
Trial summary
With Diabetic gastroparesis as the research object, by the method of multi-center RCT and single cavity and different acupuncture acupoints compatibility treatment of diabetic gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as validity checking means, for single cavity with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Diabetic Gastroparesis;
- Aged 18-60 (including 18 and 60);
- Fasting venous blood sugar ≤7.8mmol/L,2-hour post-meal blood glucose ≤ 13.6mmol/ L;
- Diabetes more than 3 years;
- Diet and exercise therapy or diet movement and exercise therapy based on the use of hypoglycemic drugs (except alpha glycosidase inhibitor) treatment, dose stable at least more than 3 months;
- Rounding out the top three months did not participate in any clinical subjects;
- Sign the informed consent and voluntary to participate in the study.
Who cannot join
- Patients with reflux esophagitis;
- Postoperative gastroparesis patients;
- Ketoacidosis, non ketosis acute complications such as hypertonic coma;
- Patients with acute cardiovascular disease, with severe trauma or surgery, severe infections, pregnancy or breast-feeding women;
- Patients with myocardial infa,acute coronary syndrome (ACS),coronary revascularization;
- Patients with severe liver disease, or the AST and/or ALT 2 times higher than normal ceiling;
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- Patients with Serum creatinine kidney damage, more than 140 umol/L;
- Patients with obvious blood system diseases (either in person are not to be included in the item: Hb: men < 110 g/L, women < 100 g/L, the WBC < 3.5×109/L/L, PLT < 80×109/L);
- Patients's systolic pressure≥180mmHg,Patients's diastolic pressure≥100mmHg;
- Patients with Advanced malignant tumor or other serious wasting disease, infection and bleeding;
- Endoscopy has the organic lesion such as peptic ulcer;
- Disorders or do not fit the person and the growing experiment condition or severe complications;
- Nearly four weeks of alpha glycosidase inhibitor drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun, Jilin, 130117
Tie Li, Ph.D, +86 0431 86714973, zusanli_1999@126.com
About this study
Official title: Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
With Diabetic gastroparesis as the research object, by the method of multi-center RCT and single cavity and different acupuncture acupoints compatibility treatment of diabetic gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as validity checking means, for single cavity with different acupoints compatibility evaluate clinical efficacy of treatment of diabetic gastroparesis.
Read the detailed description
In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of diabetic gastroparesis as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.
Diabetic gastroparesis in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the diabetic gastroparesis is acupuncture clinical diseases. This project by diabetic gastroparesis as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.
- Conditions
- Diabetic Gastroparesis
- Being tested
- acupuncture
- Keywords
- Different acupoints compatibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Patients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
acupunctureDevice
Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment, follow-up after 4 weeks.
acupunctureDevice
Patients in Control group,will be acupuncture with at the junction of deltoid and biceps,needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single point group (Zhongwan) | Other | Patients will be acupuncture with Zhongwan(RN12). Receives: Device: acupuncture |
| Combination of He-Mu points group | Other | Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12). Receives: Device: acupuncture |
| Control group | Other | Patients in Control group,will be acupuncture with at the junction of deltoid and biceps. Receives: Device: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroparesis Symptoms Rating Scale(GCSI)
Measured: 8 weeks
Secondary outcomes (7)
FBG(fasting blood-glucose)
Measured: 8 weeks
PPG(postprandial blood sugar)
Measured: 8 weeks
Gastric emptying check by Color ultrasonography
Measured: 8 weeks
Gastric emptying check by X rays
Measured: 8 weeks
Short form 36 health survey(SF-36)
Measured: 8 weeks
Self-rating anxiety scale(SAS)
Measured: 1 week
Self-Rating Depression Scale(SDS)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Hengyang Traditional Chinese Medicine Hospital, Second People's Hospital of Hunan, Jilin University, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Tie Li, Changchun University of Chinese Medicine
- Investigators
- Fuchun Wang, master, Study chair, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452489
- Sponsor's protocol ID
- ChangchunUCM02
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu R, He M, Zhao X, Sun M, Cao J, Wang X, Wang X, Zhao S, Wang F, Li T. Effects of stimulating single acupoint and combination acupoints on diabetic gastroparesis: A randomised controlled trial study. J Tradit Complement Med. 2024 Jan 23;14(4):446-455. doi: 10.1016/j.jtcme.2024.01.008. eCollection 2024 Jul.
PubMed 39035685
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
- ClinicalTrials.gov ID
- NCT02452489
- Acronym / sponsor ID
- ChangchunUCM02
- Conditions
- Diabetic Gastroparesis
- Keywords
- Different acupoints compatibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Changchun University of Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Hengyang Traditional Chinese Medicine Hospital, Second People's Hospital of Hunan, Jilin University, Qilu Hospital of Shandong University
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With Diabetic gastroparesis as the research object, by the method of multi-center RCT and single cavity and different acupuncture acupoints compatibility treatment of diabetic gastroparesis, the inspection of gastric emptying, gastric dynamic inspection, such as validity checking means, for single cavity with different acupoints compatibility evaluate clinical efficacy of treatment of diabetic gastroparesis.
Detailed description
In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of diabetic gastroparesis as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.
Diabetic gastroparesis in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the diabetic gastroparesis is acupuncture clinical diseases. This project by diabetic gastroparesis as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single point group (Zhongwan) | Other | Device: acupuncturePatients will be acupuncture with Zhongwan(RN12). |
| Combination of He-Mu points group | Other | Device: acupuncturePatients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12). |
| Control group | Other | Device: acupuncturePatients in Control group,will be acupuncture with at the junction of deltoid and biceps. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of Diabetic Gastroparesis;
- Aged 18-60 (including 18 and 60);
- Fasting venous blood sugar ≤7.8mmol/L,2-hour post-meal blood glucose ≤ 13.6mmol/ L;
- Diabetes more than 3 years;
- Diet and exercise therapy or diet movement and exercise therapy based on the use of hypoglycemic drugs (except alpha glycosidase inhibitor) treatment, dose stable at least more than 3 months;
Key exclusion criteria (13 listed)
- Patients with reflux esophagitis;
- Postoperative gastroparesis patients;
- Ketoacidosis, non ketosis acute complications such as hypertonic coma;
- Patients with acute cardiovascular disease, with severe trauma or surgery, severe infections, pregnancy or breast-feeding women;
- Patients with myocardial infa,acute coronary syndrome (ACS),coronary revascularization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncturePatients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks. | Device | Single point group (Zhongwan) |
| acupuncturePatients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment, follow-up after 4 weeks. | Device | Combination of He-Mu points group |
| acupuncturePatients in Control group,will be acupuncture with at the junction of deltoid and biceps,needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks. | Device | Control group |
Primary outcome
Gastroparesis Symptoms Rating Scale(GCSI)
Time frame: 8 weeks
7 secondary outcomes
FBG(fasting blood-glucose)
Time frame: 8 weeks
PPG(postprandial blood sugar)
Time frame: 8 weeks
Gastric emptying check by Color ultrasonography
Time frame: 8 weeks
Gastric emptying check by X rays
Time frame: 8 weeks
Short form 36 health survey(SF-36)
Time frame: 8 weeks
Self-rating anxiety scale(SAS)
Time frame: 1 week
Self-Rating Depression Scale(SDS)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Derived from this study: PubMed 39035685Liu R, He M, Zhao X, Sun M, Cao J, Wang X, Wang X, Zhao S, Wang F, Li T. Effects of stimulating single acupoint and combination acupoints on diabetic gastroparesis: A randomised controlled trial study. J Tradit Complement Med. 2024 Jan 23;14(4):446-455. doi: 10.1016/j.jtcme.2024.01.008. eCollection 2024 Jul.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuchun Wang, master study chair
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acupuncture in people with Diabetic Gastroparesis, run by Changchun University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tie Li, Ph.D (+86 0431 86714973, zusanli_1999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroparesis Symptoms Rating Scale(GCSI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.