Acupuncture in the Complementary Treatment of Diabetes Mellitus Type II

Diabetes Mellitus Clinical Trial

— ACT-DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02605889
• Other study ID #: 772.509
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2015
• Last updated: November 12, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: Universidade Federal do Rio de Janeiro
• Contact: CLAUDIA Pereira, student
• Phone: 21985876257
• Email: cdayube[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Laser acupuncture
Laser acupuncture

Locations

Country	Name	City	State
Brazil	Claudia Dayube Pereira	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
NEIDE APARECIDA TITONELLI ALVIM

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of blood postprandial glucose levels		six week	No
Secondary	Improvement of Nursing Diagnoses		six week	No