Acupuncture in the Complementary Treatment of Diabetes Mellitus Type II

Study Overview
=================
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.

Official Title
-----------------
Acupuncture in the Treatment of Diabetes Mellitus Supplemental Type II : Applied Clinical Intervention by Nurses Acupuncturists

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Laser acupuncture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Laser acupuncture | Other: Laser acupuncture<br>* Laser acupuncture<br>|
| Sham Comparator: Group B<br>Simulation Laser acupuncture | Other: Laser acupuncture<br>* Laser acupuncture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Nursing Diagnoses |  | six week |