NCT01356953

Brief Summary

The purpose of this study is to determine if a single session of aerobic exercise effectively controls the blood pressure (BP) of individuals with type 2 diabetes mellitus (T2DM) over the 24h of post-exercise period, and the effects of intensity of aerobic exercise on these BP responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable type-2-diabetes

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

October 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
Last Updated

May 20, 2011

Status Verified

September 1, 2008

Enrollment Period

9 months

First QC Date

May 10, 2011

Last Update Submit

May 19, 2011

Conditions

Type 2 Diabetes

Keywords

Aerobic ExerciseBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure - Ambulatory blood pressure monitoring (ABPM)

    Participants will be followed for the duration of experimental tests, an expected average of 4 weeks

Study Arms (1)

Aerobic Exercise

EXPERIMENTAL
Other: Aerobic exercise

Interventions

Aerobic exerciseOTHER

Intensity of aerobic exercise

Aerobic Exercise

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sedentary
  • a diagnosis of T2DM for at least one year
  • glycemic control through nutrition and/or medication

You may not qualify if:

  • be not under use of exogenous insulin and do not present chronic complications such as diabetic foot
  • nephropathy
  • retinopathy
  • neuropathies and cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Brasilia

Taguatinga, 72030-170, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 20, 2011

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

May 20, 2011

Record last verified: 2008-09

Locations

BR(1)