NCT01983007

Brief Summary

Endothelial dysfunction precedes the development of cardiovascular disease and it is common in patients with diabetes mellitus. The aim of this study is to identify the effect of two different physical training programs, using ultrasound techniques, on the endothelial function of patients with type 2 DM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

November 6, 2013

Last Update Submit

March 20, 2014

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus.

Outcome Measures

Primary Outcomes (1)

  • Arterial dilation

    6 weeks

Study Arms (2)

high-intensity exercise group

EXPERIMENTAL

Patients undergoing high-intensity exercise group. Intervention: high-intensity exercise.

Procedure: High-intensity exercise

low-intensity exercise group

EXPERIMENTAL

Patients undergoing low-intensity exercise group Intervention: low-intensity exercise

Procedure: Low-intensity exercise

Interventions

High-intensity exercisePROCEDURE

Performance of high-intensity exercise

high-intensity exercise group
Low-intensity exercisePROCEDURE

Performance of low-intensity exercise

low-intensity exercise group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with type 2 DM, of both genders, aged between 40 and 65 years, without coronary artery disease, characterized by a negative maximum exercise test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention and Cardiovascular Rehabilitation Unit Unicardio, in Hospital Santa Catarina

Blumenau, Santa Catarina, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carlos Alberto Silva, PhD

    Universidade Federal do Ceara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

BR(1)