Metabolic DisturbanceNCT03502304
Concurrent Training and Prediabetes Control
A study testing Endurance training plus resistant training in people with Metabolic Disturbance, run by Universidad Santo Tomas at 1 site in Chile.
Trial summary
Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance
- What is being tested?
- Endurance training plus resistant training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChile
- Study dates
- 10 Jun 2017to 9 Apr 2018
- 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 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent.
- Interested in improving health and fitness.
Who cannot join
- Cardiovascular contraindications to exercise,
- History of stroke, asthma or chronic obstructive pulmonary disease,
- Muscle-skeletal disorders, and
- Smoking.
- A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points
Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).
- Conditions
- Metabolic Disturbance
- Being tested
- Endurance training plus resistant training
- Keywords
- Metabolic syndrome, Obesity
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance training plus resistant trainingBehavioural
CT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | No-exercise Receives: Behavioral: Endurance training plus resistant training |
| Endurance training plus resistant training | Experimental | To concurrent training (endurance training plus resistant training, RT) program will be use cycle ergometers adapted for obese adults (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Prior to the CT intervention, all subjects were familiarized (during 3 sessions) with the training protocols. The CT intervention included 3 weekly sessions of both ET and RT. The core part of each session included RT followed by ET exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements. Receives: Behavioral: Endurance training plus resistant training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Change from Baseline in fasting glucose
Measured: Baseline and 20-weeks immediately after the interventions ends
Lipoproteins
Change from baseline in lipoproteins
Measured: Baseline and 20-weeks immediately after the interventions ends
Secondary outcomes (6)
Body mass
Change from Baseline in body mass
Measured: Baseline and 20-weeks immediately after the interventions ends
Waist circumference
Change from Baseline in waist circumference
Measured: Baseline and 20-weeks immediately after the interventions ends
Fat mass
Change from Baseline in fat mass
Measured: Baseline and 20-weeks immediately after the interventions ends
Lean mass
Change from Baseline in lean mass
Measured: Baseline and 20-weeks immediately after the interventions ends
Heart rate at rest
Change from Baseline in heart rate at rest
Measured: Baseline and 20-weeks immediately after the interventions ends
Six minutes walking test
Change from Baseline in six minutes walking test
Measured: Baseline and 20-weeks immediately after the interventions ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start10 Jun 2017
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Los Lagos, Healthcare Center Tomas Rojas, Universidad del Rosario
- Responsible party
- Sponsor
- Investigators
- Cristian Alvarez, PhD, Principal investigator, Universidad de Los Lagos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502304
- Sponsor's protocol ID
- 9042018
- Status last verified
- May 2018
- First submitted
- 9 Apr 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points
- ClinicalTrials.gov ID
- NCT03502304
- Acronym / sponsor ID
- 9042018
- Conditions
- Metabolic Disturbance
- Keywords
- Metabolic syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Santo TomasUniversity, hospital or other
- Collaborators
- Universidad de Los Lagos, Healthcare Center Tomas Rojas, Universidad del Rosario
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Behavioral
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Endurance training plus resistant trainingNo-exercise |
| Endurance training plus resistant training | Experimental | Behavioral: Endurance training plus resistant trainingTo concurrent training (endurance training plus resistant training, RT) program will be use cycle ergometers adapted for obese adults (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Prior to the CT intervention, all subjects were familiarized (during 3 sessions) with the training protocols. The CT intervention included 3 weekly sessions of both ET and RT. The core part of each session included RT followed by ET exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written informed consent.
- Interested in improving health and fitness.
Key exclusion criteria (5 listed)
- Cardiovascular contraindications to exercise,
- History of stroke, asthma or chronic obstructive pulmonary disease,
- Muscle-skeletal disorders, and
- Smoking.
- A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.
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 |
|---|---|---|
| Endurance training plus resistant trainingCT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks. | Behavioural | Control group, Endurance training plus resistant training |
Primary outcome
Fasting glucose
Time frame: Baseline and 20-weeks immediately after the interventions ends
Change from Baseline in fasting glucose
Lipoproteins
Time frame: Baseline and 20-weeks immediately after the interventions ends
Change from baseline in lipoproteins
6 secondary outcomes
Body mass
Time frame: Baseline and 20-weeks immediately after the interventions ends
Waist circumference
Time frame: Baseline and 20-weeks immediately after the interventions ends
Fat mass
Time frame: Baseline and 20-weeks immediately after the interventions ends
Lean mass
Time frame: Baseline and 20-weeks immediately after the interventions ends
Heart rate at rest
Time frame: Baseline and 20-weeks immediately after the interventions ends
Six minutes walking test
Time frame: Baseline and 20-weeks immediately after the interventions ends
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 31 May 2018.
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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.
Cristian Alvarez, PhD principal investigator
Universidad de Los Lagos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training plus resistant training in people with Metabolic Disturbance, run by Universidad Santo Tomas at 1 site in Chile.
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 31 May 2018. 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 Chile. 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?
Fasting glucose (time frame: Baseline and 20-weeks immediately after the interventions ends). The study lists 2 primary outcomes in all. 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 31 May 2018.