Metabolic SyndromeNCT03036332
Exercise Training and Metabolic Syndrome
A study testing Aerobic interval training in people with Metabolic Syndrome, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
The present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Aerobic interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 10 Dec 2016
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having metabolic syndrome according to international diabetes foundations definition (IDF).
- Age between 35 - 60 years and untrained subjects.
Who cannot join
- Musculotendinous or osteoarticular injuries in the lower limbs and/or spine
- Chronic pulmonary diseases
- Neurological disorders
- Kidney failure
- High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).
About this study
Official title: Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome
The present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.
Read the detailed description
Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.
- Conditions
- Metabolic Syndrome
- Being tested
- Aerobic interval training
- Keywords
- aerobic interval training, biomarkers
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingBehavioural
Carried out 3 times per week for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Aerobic interval training Receives: Behavioral: Aerobic interval training |
| Control group | No intervention | The participants performed only initial evaluation and at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-inflammatory marker
Serum levels of C-reactive protein
Measured: 16 weeks
Secondary outcomes (2)
Quality of life
The Medical Outcomes Study-Short Form 36 (SF-36)
Measured: 16 weeks
A set of clinical biomarkers
Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Jun 2015
- Primary completion10 Dec 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo Augusto Travagin Miranda, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Rodolfo AT Miranda, Me, Principal investigator, Universidade Estadual Paulista Júlio de Mesquita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036332
- Sponsor's protocol ID
- RATMiranda1
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03036332
- Acronym / sponsor ID
- RATMiranda1
- Conditions
- Metabolic Syndrome
- Keywords
- aerobic interval training, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 30 Jan 2017 (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 present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.
Detailed description
Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. Such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Aerobic interval trainingAerobic interval training |
| Control group | No intervention | –The participants performed only initial evaluation and at the end of the study |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having metabolic syndrome according to international diabetes foundations definition (IDF).
- Age between 35 - 60 years and untrained subjects.
Key exclusion criteria (5 listed)
- Musculotendinous or osteoarticular injuries in the lower limbs and/or spine
- Chronic pulmonary diseases
- Neurological disorders
- Kidney failure
- High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).
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 interval trainingCarried out 3 times per week for 16 weeks | Behavioural | intervention |
Primary outcome
Pro-inflammatory marker
Time frame: 16 weeks
Serum levels of C-reactive protein
2 secondary outcomes
Quality of life
Time frame: 16 weeks
A set of clinical biomarkers
Time frame: 16 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 30 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Rodolfo AT Miranda, Me principal investigator
Universidade Estadual Paulista Júlio de Mesquita
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic interval training in people with Metabolic Syndrome, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 2 inclusion and 5 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pro-inflammatory marker (time frame: 16 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 30 Jan 2017.