Type 2 DiabetesEIT2DNCT01356953
Exercise Intensity and Type 2 Diabetics
A study testing Aerobic exercise in people with Type 2 Diabetes, run by Catholic University of Brasília at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sedentary
- a diagnosis of T2DM for at least one year
- glycemic control through nutrition and/or medication
Who cannot join
- be not under use of exogenous insulin and do not present chronic complications such as diabetic foot
- nephropathy
- retinopathy
- neuropathies and cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Intensity on 24-h Ambulatory Blood Pressure in Type 2 Diabetics
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Aerobic exercise
- Keywords
- Aerobic Exercise, Blood Pressure
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Intensity of aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Not described Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure - Ambulatory blood pressure monitoring (ABPM)
Measured: Participants will be followed for the duration of experimental tests, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startOct 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Brasília
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356953
- Sponsor's protocol ID
- MORAIS0132008
- Acronym
- EIT2D
- Status last verified
- Sep 2008
- First submitted
- 10 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Intensity on 24-h Ambulatory Blood Pressure in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT01356953
- Acronym / sponsor ID
- EIT2D / MORAIS0132008
- Conditions
- Type 2 Diabetes
- Keywords
- Aerobic Exercise, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Catholic University of BrasíliaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Other: Aerobic exercise |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sedentary
- a diagnosis of T2DM for at least one year
- glycemic control through nutrition and/or medication
Key exclusion criteria (4 listed)
- be not under use of exogenous insulin and do not present chronic complications such as diabetic foot
- nephropathy
- retinopathy
- neuropathies and cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseIntensity of aerobic exercise | Other | Aerobic Exercise |
Primary outcome
Blood Pressure - Ambulatory blood pressure monitoring (ABPM)
Time frame: Participants will be followed for the duration of experimental tests, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Type 2 Diabetes, run by Catholic University of Brasília at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure - Ambulatory blood pressure monitoring (ABPM) (time frame: Participants will be followed for the duration of experimental tests, an expected average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2011.