Metabolism DisorderNCT03003754
Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile
A study testing High Intensity Training (HIT) + Resistance Training (RT) in people with Metabolism Disorder and Insulin Sensitivity, run by Universidad Santo Tomas at 1 site in Colombia.
Trial summary
Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide interindividual variability after exercise training explored mainly in adults but not in children. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder, Insulin Sensitivity, Obesity, Pediatric
- What is being tested?
- High Intensity Training (HIT) + Resistance Training (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2015to Feb 2017
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed of insulin resistance by one of three plasmatic glucose control: HOMA-IR ≥3.0,
- Fasting insulin levels ≥15 µUI/dL or fasting glucose ≥100 and ≤126 mg/dL within the enrolment stage applied at school (i.e., ≤3 months),
- Physical inactivity (volume of ≤60 min/day of moderate physical activity),
- To be participating of regular practical physical education classes at school (i.e., 90 min/week),
- Living only in urban areas.
Who cannot join
- Potential medical, musculoskeletal problems or a familial history of T2DM,
- Ischemic disease,
- Arrhythmia,
- Asthma,
- Utilization of drugs that modulate the metabolic and respiratory control.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Robinson Ramírez-Vélez
Bogota Distrito Especial, Cundinamarca, 000000000
About this study
Official title: Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile: Cardiometabolic Risk Factors and Muscular Strength Changes in Responders and Non Responders
Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide interindividual variability after exercise training explored mainly in adults but not in children. Thus, is yet unknown what baseline health status as well as the influence of what health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes) after exercise training in school children.
- Conditions
- Metabolism Disorder, Insulin Sensitivity, Obesity, Pediatric
- Being tested
- High Intensity Training (HIT) + Resistance Training (RT), Control group
- Medical subject headings
- Metabolic Diseases, Insulin Resistance, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Training (HIT) + Resistance Training (RT)Behavioural
Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.
Control groupBehavioural
Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Training (HIT) + Resistance Training (RT) | Experimental | To HIT program will be use cycle ergometers adapted for children (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Each participant performed a range of 8 to 14 cycling intervals during the intervention period. The time of each work interval cycling will be increased progressively weekly, and ranged between 40-60 s (40 s weeks 1-2; 50 s weeks 3-5; 60 s week 6), with 120 s of passive rest (over the bicycle without movement) between each interval of work.
The RT will consist in voluntary concentric/eccentric exercise during 1 minute until to get a high subjective effort perception (i.e., between 8-10 points based on the modified and subjective Borg scale of 1 to 10 points. Subjects will perform 4 exercises (biceps curl, leg-extension, shoulders press, and upper row exercise) during 6-weeks. Receives: Behavioral: High Intensity Training (HIT) + Resistance Training (RT) |
| Control group | Active comparator | We will compare within each group (G)-1, G-2, and G-3 sub-group according to both RT and HIT intervention both pre-post changes as well as if are there some anthropometric, cardiovascular, and performance variable predicting changes in homeostasis model assessment (HOMA-IR). Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)
Measured: Baseline and 6 weeks immediately after the interventions ends
Secondary outcomes (11)
Change from Baseline in body mass
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in body mass index
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in waist circumference
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fat mass
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in blood pressure
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting glucose
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting insulin
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of leg-extension exercise
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of shoulder press exercise
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of upper-row exercise
Measured: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of biceps curl exercise
Measured: Baseline and 6 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 posted28 Dec 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolism DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas
- Sponsor type
- University, hospital or other
- Collaborators
- Healthcare Center Tomas Rojas, Health Service of Los Ríos by the Health promotion program, Universidad Pública de Navarra, Universidad del Rosario
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003754
- Sponsor's protocol ID
- 2016-12-22
- Status last verified
- Oct 2018
- First submitted
- 22 Dec 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Martinez C, Castro-Sepulveda M, Alonso-Martinez A, Izquierdo M. Metabolic effects of resistance or high-intensity interval training among glycemic control-nonresponsive children with insulin resistance. Int J Obes (Lond). 2018 Jan;42(1):79-87. doi: 10.1038/ijo.2017.177. Epub 2017 Jul 31.
PubMed 28757639
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile: Cardiometabolic Risk Factors and Muscular Strength Changes in Responders and Non Responders
- ClinicalTrials.gov ID
- NCT03003754
- Acronym / sponsor ID
- 2016-12-22
- Conditions
- Metabolism Disorder, Insulin Sensitivity, Obesity, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Santo TomasUniversity, hospital or other
- Collaborators
- Healthcare Center Tomas Rojas, Health Service of Los Ríos by the Health promotion program, Universidad Pública de Navarra, Universidad del Rosario
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Dec 2016 (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.
Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide interindividual variability after exercise training explored mainly in adults but not in children. Thus, is yet unknown what baseline health status as well as the influence of what health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes) after exercise training in school children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Training (HIT) + Resistance Training (RT) | Experimental | Behavioral: High Intensity Training (HIT) + Resistance Training (RT)To HIT program will be use cycle ergometers adapted for children (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Each participant performed a range of 8 to 14 cycling intervals during the intervention period. The time of each work interval cycling will be increased progressively weekly, and ranged between 40-60 s (40 s weeks 1-2; 50 s weeks 3-5; 60 s week 6), with 120 s of passive rest (over the bicycle without movement) between each interval of work. The RT will consist in voluntary concentric/eccentric exercise during 1 minute until to get a high subjective effort perception (i.e., between 8-10 points based on the modified and subjective Borg scale of 1 to 10 points. Subjects will perform 4 exercises (biceps curl, leg-extension, shoulders press, and upper row exercise) during 6-weeks. |
| Control group | Active comparator | Behavioral: Control groupWe will compare within each group (G)-1, G-2, and G-3 sub-group according to both RT and HIT intervention both pre-post changes as well as if are there some anthropometric, cardiovascular, and performance variable predicting changes in homeostasis model assessment (HOMA-IR). |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed of insulin resistance by one of three plasmatic glucose control: HOMA-IR ≥3.0,
- Fasting insulin levels ≥15 µUI/dL or fasting glucose ≥100 and ≤126 mg/dL within the enrolment stage applied at school (i.e., ≤3 months),
- Physical inactivity (volume of ≤60 min/day of moderate physical activity),
- To be participating of regular practical physical education classes at school (i.e., 90 min/week),
- Living only in urban areas.
Key exclusion criteria (5 listed)
- Potential medical, musculoskeletal problems or a familial history of T2DM,
- Ischemic disease,
- Arrhythmia,
- Asthma,
- Utilization of drugs that modulate the metabolic and respiratory control.
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 |
|---|---|---|
| High Intensity Training (HIT) + Resistance Training (RT)Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks. | Behavioural | High Intensity Training (HIT) + Resistance Training (RT) |
| Control groupPost statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks. | Behavioural | Control group |
Primary outcome
Change from Baseline in plasma homeostasis model assessment (HOMA-IR)
Time frame: Baseline and 6 weeks immediately after the interventions ends
11 secondary outcomes
Change from Baseline in body mass
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in body mass index
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in waist circumference
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fat mass
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in blood pressure
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting glucose
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in fasting insulin
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of leg-extension exercise
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of shoulder press exercise
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of upper-row exercise
Time frame: Baseline and 6 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of biceps curl exercise
Time frame: Baseline and 6 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 15 Oct 2018.
- Derived from this study: PubMed 28757639Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Martinez C, Castro-Sepulveda M, Alonso-Martinez A, Izquierdo M. Metabolic effects of resistance or high-intensity interval training among glycemic control-nonresponsive children with insulin resistance. Int J Obes (Lond). 2018 Jan;42(1):79-87. doi: 10.1038/ijo.2017.177. Epub 2017 Jul 31.
- 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.
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 High Intensity Training (HIT) + Resistance Training (RT) in people with Metabolism Disorder and Insulin Sensitivity, run by Universidad Santo Tomas at 1 site in Colombia.
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 5 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 15 Oct 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 Colombia. 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?
Change from Baseline in plasma homeostasis model assessment (HOMA-IR) (time frame: Baseline and 6 weeks immediately after the interventions ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003754, which also lists 1 linked publication.
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 15 Oct 2018.