NCT02605889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

November 9, 2015

Last Update Submit

November 12, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement of blood postprandial glucose levels

    six week

Secondary Outcomes (1)

  • Improvement of Nursing Diagnoses

    six week

Study Arms (2)

Group A

EXPERIMENTAL

Laser acupuncture

Other: Laser acupuncture

Group B

SHAM COMPARATOR

Simulation Laser acupuncture

Other: Laser acupuncture

Interventions

Laser acupuncture

Group AGroup B

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudia Dayube Pereira

Rio de Janeiro, Rio de Janeiro, 24900000, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Neide Alvim, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CLAUDIA Pereira, student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd Nursing

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 16, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations