Diabetic GastroparesisPhase 3NCT00470795
Acupuncture for Diabetic Gastroparesis
A Phase 3 study testing Acupuncture in people with Diabetic Gastroparesis, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial summary
Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to medications and invasive procedures, all of which offer only partial and transient relief, with some options having potentially harmful… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2009to Sep 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older;
- Controlled diabetes (<250 mg/dL);
- Moderate gastroparesis (GCSI > 2.50);
- Ability to comply with study protocol
Who cannot join
- Past experience with acupuncture;
- History of gastric surgery, intrapyloric botulinum toxin, gastric pacemaker;
- Uncontrolled diabetes or evidence of diabetic ketoacidosis;
- Malabsorptive syndrome, liver or pulmonary disease;
- Pregnancy or fertility treatments;
- Overt psychopathology.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Jerusalem, 91031
Dept. of Gastroenterology, Hadassah University Hospital
Jerusalem
About this study
Official title: A Randomized, Placebo/Sham-Controlled, Double-Blind Crossover Study to Assess the Efficacy of Acupuncture in the Treatment of Diabetic Gastroparesis.
Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to medications and invasive procedures, all of which offer only partial and transient relief, with some options having potentially harmful effects. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, including those involving the gastrointestinal tract. We propose to evaluate whether acupuncture is an effective and safe treatment for diabetic gastroparesis using a randomized, double-blind, placebo/sham-controlled crossover trial. Because symptoms of gastroparesis do not correlate well with objective tests of gastric emptying (i.e., scintigraphy or 13C breath tests), our primary outcome value will be the Gastroparesis Cardinal Symptom Index (GCSI), a reliable and validated instrument for quantifying symptoms in these patients. As a secondary outcome we will measure gastric emptying using a C13-acetate breath test, as well as the SF-12 Short Form Health Survey. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.
Diabetic patients suffering from moderate gastroparesis (total GCSI score > 2.50) who fulfill the inclusion criteria (and none of the exclusion criteria) will be eligible to participate in the study. On induction, participants will fill out the GCSI questionnaire and SF-36 survey, and will undergo a C13-acetate breath test. They will then be randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant will undergo 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a GCSI questionnaire and SF-12 form, as well as repeating the C13-acetate breath. Following a 4-week washout period, patients will be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly treatments, for a period of 4 weeks. At the end of the second treatment regimen all participants will again fill out a GCSI questionnaire and SF-12 form, and undergo a C13-acetate breath test. At the end of the second treatment regimen participants will again fill out a Validation of Blinding Questionnaire.
- Conditions
- Diabetic Gastroparesis
- Being tested
- Acupuncture, placebo/sham acupuncture
- Keywords
- diabetes, gastroparesis, acupuncture, symptoms, gastric emptying
- Medical subject headings
- Diabetes Mellitus, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
acupuncture treatment (or placebo), 20 minute treatment each; twice weekly for four weeks (total of eight treatments). repeat treatment schedule following crossover (placebo-treatment)
placebo/sham acupunctureProcedure or surgery
acupuncture at sham points without skin penetration
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Acupuncture - 2 treatments weekly, 4 weeks (8 treatment) Receives: Other: Acupuncture |
| B | Placebo comparator | Placebo/sham treatment; twice weekly for 4 weeks (total 8 treatments) Receives: Procedure: placebo/sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCSI score
Measured: 3 months
Secondary outcomes (1)
SF-12 Health Survey Questionnaire; C-13 acetate breath test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: Protocol to be re-designed (primary outome still GCSI)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Noah Samuels, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, IsraelJoseph Lysy, M.D., Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470795
- Sponsor's protocol ID
- ACP.GP.07
- Status last verified
- Dec 2008
- First submitted
- 7 May 2007
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo/Sham-Controlled, Double-Blind Crossover Study to Assess the Efficacy of Acupuncture in the Treatment of Diabetic Gastroparesis.
- ClinicalTrials.gov ID
- NCT00470795
- Acronym / sponsor ID
- ACP.GP.07
- Conditions
- Diabetic Gastroparesis
- Keywords
- diabetes, gastroparesis, acupuncture, symptoms, gastric emptying
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol to be re-designed (primary outome still GCSI)
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 8 May 2007 (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.
Gastroparesis is a common complication of prolonged diabetes mellitus, both with Type 1 and Type 2 forms. Treatment of diabetic gastroparesis ranges from changing dietary habits to medications and invasive procedures, all of which offer only partial and transient relief, with some options having potentially harmful effects. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, including those involving the gastrointestinal tract. We propose to evaluate whether acupuncture is an effective and safe treatment for diabetic gastroparesis using a randomized, double-blind, placebo/sham-controlled crossover trial. Because symptoms of gastroparesis do not correlate well with objective tests of gastric emptying (i.e., scintigraphy or 13C breath tests), our primary outcome value will be the Gastroparesis Cardinal Symptom Index (GCSI), a reliable and validated instrument for quantifying symptoms in these patients. As a secondary outcome we will measure gastric emptying using a C13-acetate breath test, as well as the SF-12 Short Form Health Survey. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.
Diabetic patients suffering from moderate gastroparesis (total GCSI score > 2.50) who fulfill the inclusion criteria (and none of the exclusion criteria) will be eligible to participate in the study. On induction, participants will fill out the GCSI questionnaire and SF-36 survey, and will undergo a C13-acetate breath test. They will then be randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. Each participant will undergo 8 treatments twice-weekly, for a period of 4 weeks. At the end of the eighth treatment session, each participant will again fill out a GCSI questionnaire and SF-12 form, as well as repeating the C13-acetate breath. Following a 4-week washout period, patients will be crossed over to either placebo/sham or true acupuncture treatment, again 8 twice-weekly treatments, for a period of 4 weeks. At the end of the second treatment regimen all participants will again fill out a GCSI questionnaire and SF-12 form, and undergo a C13-acetate breath test. At the end of the second treatment regimen participants will again fill out a Validation of Blinding Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: AcupunctureAcupuncture - 2 treatments weekly, 4 weeks (8 treatment) |
| B | Placebo comparator | Procedure: placebo/sham acupuncturePlacebo/sham treatment; twice weekly for 4 weeks (total 8 treatments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older;
- Controlled diabetes (<250 mg/dL);
- Moderate gastroparesis (GCSI > 2.50);
- Ability to comply with study protocol
Key exclusion criteria (6 listed)
- Past experience with acupuncture;
- History of gastric surgery, intrapyloric botulinum toxin, gastric pacemaker;
- Uncontrolled diabetes or evidence of diabetic ketoacidosis;
- Malabsorptive syndrome, liver or pulmonary disease;
- Pregnancy or fertility treatments;
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 |
|---|---|---|
| Acupunctureacupuncture treatment (or placebo), 20 minute treatment each; twice weekly for four weeks (total of eight treatments). repeat treatment schedule following crossover (placebo-treatment) | Other | A |
| placebo/sham acupunctureacupuncture at sham points without skin penetration | Procedure or surgery | B |
Primary outcome
GCSI score
Time frame: 3 months
1 secondary outcome
SF-12 Health Survey Questionnaire; C-13 acetate breath test
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Active, not recruiting
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Diabetes Mellitus, Gastroparesis With Diabetes Mellitus
Recruiting
Washed Microbiota Transplantation for Diabetic Gastroparesis
Diabetic Gastroparesis
Recruiting
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
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.
Noah Samuels, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
Joseph Lysy, M.D. principal investigator
Hadassah University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture in people with Diabetic Gastroparesis, run by Shaare Zedek Medical Center at 2 sites in Israel.
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 4 inclusion and 6 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: paused, as of the sponsor's last update on 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCSI score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2008.