Diabetes MellitusACT-DMNCT02605889
Acupuncture in the Complementary Treatment of Diabetes Mellitus Type II
A study testing Laser acupuncture in people with Diabetes Mellitus, run by NEIDE APARECIDA TITONELLI ALVIM at 1 site in Brazil.
Trial summary
This is a randomized clinical research, with triple blinded multicenter involving the Federal University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of Espirito Santo, represented by the… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Laser acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Jan 2016
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be in possession of Diabetes Mellitus Type II only
- It is undergoing treatment for at least 1 year properly prescribed (to be confirmed with the medication of revenue)
- Report difficulties in glycemic control, regular saving measures higher than recommended by the Brazilian Society of Diabetes (postprandial up to 180mg / dl)
Who cannot join
- Have a lower limb amputated or part of them (because of the location of the selected acupoints for the treatment protocol)
- Be insulin
- Being a smoker
- Be alcoholic
- Be in drug treatment for other diseases including obesity
- Be making specific diet for weight loss
Show all 9Show fewer
- Practicing regular physical activity
- Be in possession of cancer
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Claudia Dayube Pereira
Rio de Janeiro, Rio de Janeiro, 24900000
Claudia d pereira, 552198587536257
About this study
Official title: Acupuncture in the Treatment of Diabetes Mellitus Supplemental Type II : Applied Clinical Intervention by Nurses Acupuncturists
This is a randomized clinical research, with triple blinded multicenter involving the Federal University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's Programme in Public Policy and Local Development.
As Research, the study covers health units of the Municipal Family Health Maricá / Rio de Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.
The object of investigation is the effectiveness of acupuncture in nursing care in complementary treatment of adult patients Diabetes Mellitus type II.
Read the detailed description
This study has the general objective to evaluate the effectiveness of acupuncture as a complementary treatment to medication used in patients with diabetes mellitus type II, based on the nursing diagnoses.
- Conditions
- Diabetes Mellitus
- Being tested
- Laser acupuncture
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureOther
Laser acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Laser acupuncture Receives: Other: Laser acupuncture |
| Group B | Sham comparator | Simulation Laser acupuncture Receives: Other: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of blood postprandial glucose levels
Measured: six week
Secondary outcomes (1)
Improvement of Nursing Diagnoses
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEIDE APARECIDA TITONELLI ALVIM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NEIDE APARECIDA TITONELLI ALVIM, Universidade Federal do Rio de Janeiro
- Investigators
- Neide Alvim, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605889
- Sponsor's protocol ID
- 772.509
- Acronym
- ACT-DM
- Status last verified
- Nov 2015
- First submitted
- 9 Nov 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in the Treatment of Diabetes Mellitus Supplemental Type II : Applied Clinical Intervention by Nurses Acupuncturists
- ClinicalTrials.gov ID
- NCT02605889
- Acronym / sponsor ID
- ACT-DM / 772.509
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- NEIDE APARECIDA TITONELLI ALVIMUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 16 Nov 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.
This is a randomized clinical research, with triple blinded multicenter involving the Federal University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's Programme in Public Policy and Local Development.
As Research, the study covers health units of the Municipal Family Health Maricá / Rio de Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.
The object of investigation is the effectiveness of acupuncture in nursing care in complementary treatment of adult patients Diabetes Mellitus type II.
Detailed description
This study has the general objective to evaluate the effectiveness of acupuncture as a complementary treatment to medication used in patients with diabetes mellitus type II, based on the nursing diagnoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Laser acupunctureLaser acupuncture |
| Group B | Sham comparator | Other: Laser acupunctureSimulation Laser acupuncture |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be in possession of Diabetes Mellitus Type II only
- It is undergoing treatment for at least 1 year properly prescribed (to be confirmed with the medication of revenue)
- Report difficulties in glycemic control, regular saving measures higher than recommended by the Brazilian Society of Diabetes (postprandial up to 180mg / dl)
Key exclusion criteria (9 listed)
- Have a lower limb amputated or part of them (because of the location of the selected acupoints for the treatment protocol)
- Be insulin
- Being a smoker
- Be alcoholic
- Be in drug treatment for other diseases including obesity
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 |
|---|---|---|
| Laser acupunctureLaser acupuncture | Other | Group A, Group B |
Primary outcome
Improvement of blood postprandial glucose levels
Time frame: six week
1 secondary outcome
Improvement of Nursing Diagnoses
Time frame: six week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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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.
Neide Alvim, PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Diabetes Mellitus, run by NEIDE APARECIDA TITONELLI ALVIM at 1 site in Brazil.
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 3 inclusion and 9 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 16 Nov 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 Brazil. 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.
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 CLAUDIA Pereira, student (21985876257, cdayube@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of blood postprandial glucose levels (time frame: six week). 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 Nov 2015.