Acupuncture in the Complementary Treatment of Diabetes Me... | NCT02605889

Studies
Acupuncture in the Complementary Treatment of Diabetes Mellitus Type II

NCT02605889

Sponsor

NEIDE APARECIDA TITONELLI ALVIM

Status

Unknown status

Last Update Posted

Nov 16, 2015Estimated

Enrollment

132Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Laser acupuncture

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Nov 9, 2015

First Submission Date that Met QC Criteria

Nov 12, 2015

First Posted Date

Nov 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2015

Last Update Posted Date

Nov 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

NEIDE APARECIDA TITONELLI ALVIM, Phd Nursing, Universidade Federal do Rio de JaneiroSponsor-Investigator

Lead Sponsor

NEIDE APARECIDA TITONELLI ALVIMOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Laser acupuncture	Other: Laser acupuncture
Group B	Sham Comparator	Simulation Laser acupuncture	Other: Laser acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser acupuncture	Other	Laser acupuncture	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of blood postprandial glucose levels		six week

Secondary Outcomes

Measure	Description	Time Frame
Improvement of Nursing Diagnoses		six week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
Practicing regular physical activity
Be in possession of cancer
Being pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CLAUDIA Pereira, student	Contact	21985876257		cdayube@hotmail.com

Overall Officials

Name	Affiliation	Role
Neide Alvim, PhD	Universidade Federal do Rio de Janeiro	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Claudia Dayube Pereira	Recruiting	Rio de Janeiro	Rio de Janeiro	24900000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided