ObesityADIBOXNCT02626273
ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents
A study testing weight loss in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- weight loss
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Oct 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All adolescent girls will have to be free of any recent history of hospitalization (past two years) or of systemic illness lasting more than two weeks in the past 12 months. .
Who cannot join
- pregnant girl
- diabetes
- insulin-resistance
- hypo or hyper-thyroid
- consuming alcohol
- smokers
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Frederic DUTHEIL
About this study
The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions.
Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.
Read the detailed description
The complex consequences of childhood obesity represent major concerns in most developed countries, largely contributing to metabolic complications with costly repercussions for the burden of disease. The burden is exemplified by high prevalence rates of overweight or obesity.
The ADIBOX protocol was designed to provide a better understanding of the bone-adipocyte cross-talk in adolescents with obesity and the effects of physical activity-induced weight loss on this cross-talk.
Obesity effectively leads to hormonal alterations favoring the accumulation of fat mass and loss of bone mass. Advancing the knowledge of the complex interactions between adipocyte and osteocyte activities may contribute to the mechanistic understanding of the body's responses to weight loss during adolescence and prevent cardiovascular risk. Indeed, the adipose-bone tissue cross-talk has been recently linked with cardiovascular diseases. Similarly as adipose tissue, released-products from bone tissue may act directly or indirectly on cardiovascular risk and diseases.
The ADIBOX study, a 40 weeks longitudinal study (LS) with repeated measures on four occasions (baseline and every fourteen weeks), will allow us to understand the effects of physical activity-induced weight loss on this cross-talk in obese adolescents.
Data will be analyzed using Stata (StataCorp, College Station, USA) and IBM Statistics SPSS version 22 (IBM Corp, 2013, Chicago, IL, USA) and significance will be accepted at a two-sided alpha level of p<0.05. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions.
Student t tests or Mann-Whitney U test will be performed to compare adipose tissue (total, subcutaneous, visceral) variation reported to bone mass variation at lumbar spine between groups at baseline. Pearson (or Spearman when appropriate) correlation coefficient will be used and compared with Fisher test (command corcor Stata) to measure the link between exercise-inducing weight loss on adipose tissue and bone mass variations. Longitudinal data will be treated using a mixed model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.
- Conditions
- Obesity
- Being tested
- weight loss
- Keywords
- obesity, adolescents, physical activity, adipocytes, osteocytes, weight loss, bone, fat
- Medical subject headings
- Obesity, Motor Activity, Weight Loss, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight lossRadiation
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | an intervention group who will undergo the management program combining physical activity and restrictive diet at Tza Nou Medical House for 10 months Receives: Radiation: weight loss |
| a control group | Other | a control group who will not undergo any intervention Receives: Radiation: weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)
Measured: at 10 months.
change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA)
Measured: at 10 months
Secondary outcomes (24)
Whole body measured by Dual energy X-ray Absorptiometry (DXA)
Measured: at 10 months
weight waist
Measured: at 10 months.
waist circumference
Measured: at 10 months.
lower limb bone lengths
Measured: at 10 months.
Physical activity measured with International Physical Activity Questionnaire
Measured: at 10 months.
Tanner's stages model for pubertal maturation
Measured: at 10 months.
Energy metabolism assessed by cycle-ergometer submaximal aerobic fitness
Measured: at 10 months.
bone mineral density measured by Peripheral Quantitative Computed Tomography
Measured: at 10 months.
bone mineral status measured by Quantitative Ultra-Sound (QUS) on the non-dominant calcaneus.
Measured: at 10 months.
Endocrine assays
Measured: at 10 months.
Adolescents' observance to the weight loss lifestyle program
Measured: at 10 months
Metabolomics analysis in blood plasma
Measured: at 10 months
Ex-vivo mechanistic analysis
Measured: at 10 months
left ventricular end diastolic diameter measured by echocardiography
Measured: at 10 months
left ventricular end systolic diameter measured by echocardiography
Measured: at 10 months
posterior wall thickness measured by echocardiography
Measured: at 10 months
interventricular septum thickness measured by echocardiography
Measured: at 10 months
left ventricular mass indexed measured by echocardiography
Measured: at 10 months
left ventricular ejection fraction measured by echocardiography
Measured: at 10 months
valves velocity measured by echocardiography
Measured: at 10 months
isovolumic relaxation time measured by echocardiography
Measured: at 10 months
strain rate measured by echocardiography
Measured: at 10 months
myocardial dyssynchrony measured by echocardiography
Measured: at 10 months
carotid-intima-media thickness measured by echography
Measured: at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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 ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Australian Catholic University, Tza Nou Medical House for children and adolescents, 230, rue Vercingétorix - B.P. 77
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626273
- Sponsor's protocol ID
- CHU-0249
- Other IDs
- 2015-A01024-45
- Acronym
- ADIBOX
- Status last verified
- Jul 2016
- First submitted
- 3 Nov 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Chaplais E, Dutheil F, Naughton G, Greene D, Pereira B, Thivel D, Courteix D. Cross-sectional and longitudinal study protocols of the 'ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents' (ADIBOX) project. BMJ Open. 2016 Oct 18;6(10):e011407. doi: 10.1136/bmjopen-2016-011407.
PubMed 27797988
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02626273
- Acronym / sponsor ID
- ADIBOX / CHU-0249
- Conditions
- Obesity
- Keywords
- obesity, adolescents, physical activity, adipocytes, osteocytes, weight loss, bone, fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, Australian Catholic University, Tza Nou Medical House for children and adolescents, 230, rue Vercingétorix - B.P. 77
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 10 Dec 2015 (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 protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions.
Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.
Detailed description
The complex consequences of childhood obesity represent major concerns in most developed countries, largely contributing to metabolic complications with costly repercussions for the burden of disease. The burden is exemplified by high prevalence rates of overweight or obesity.
The ADIBOX protocol was designed to provide a better understanding of the bone-adipocyte cross-talk in adolescents with obesity and the effects of physical activity-induced weight loss on this cross-talk.
Obesity effectively leads to hormonal alterations favoring the accumulation of fat mass and loss of bone mass. Advancing the knowledge of the complex interactions between adipocyte and osteocyte activities may contribute to the mechanistic understanding of the body's responses to weight loss during adolescence and prevent cardiovascular risk. Indeed, the adipose-bone tissue cross-talk has been recently linked with cardiovascular diseases. Similarly as adipose tissue, released-products from bone tissue may act directly or indirectly on cardiovascular risk and diseases.
The ADIBOX study, a 40 weeks longitudinal study (LS) with repeated measures on four occasions (baseline and every fourteen weeks), will allow us to understand the effects of physical activity-induced weight loss on this cross-talk in obese adolescents.
Data will be analyzed using Stata (StataCorp, College Station, USA) and IBM Statistics SPSS version 22 (IBM Corp, 2013, Chicago, IL, USA) and significance will be accepted at a two-sided alpha level of p<0.05. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions.
Student t tests or Mann-Whitney U test will be performed to compare adipose tissue (total, subcutaneous, visceral) variation reported to bone mass variation at lumbar spine between groups at baseline. Pearson (or Spearman when appropriate) correlation coefficient will be used and compared with Fisher test (command corcor Stata) to measure the link between exercise-inducing weight loss on adipose tissue and bone mass variations. Longitudinal data will be treated using a mixed model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Radiation: weight lossan intervention group who will undergo the management program combining physical activity and restrictive diet at Tza Nou Medical House for 10 months |
| a control group | Other | Radiation: weight lossa control group who will not undergo any intervention |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All adolescent girls will have to be free of any recent history of hospitalization (past two years) or of systemic illness lasting more than two weeks in the past 12 months. .
Key exclusion criteria (6 listed)
- pregnant girl
- diabetes
- insulin-resistance
- hypo or hyper-thyroid
- consuming alcohol
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 |
|---|---|---|
| weight loss | Radiation | a control group, intervention group |
Primary outcome
change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)
Time frame: at 10 months.
change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA)
Time frame: at 10 months
24 secondary outcomes
Whole body measured by Dual energy X-ray Absorptiometry (DXA)
Time frame: at 10 months
weight waist
Time frame: at 10 months.
waist circumference
Time frame: at 10 months.
lower limb bone lengths
Time frame: at 10 months.
Physical activity measured with International Physical Activity Questionnaire
Time frame: at 10 months.
Tanner's stages model for pubertal maturation
Time frame: at 10 months.
Energy metabolism assessed by cycle-ergometer submaximal aerobic fitness
Time frame: at 10 months.
bone mineral density measured by Peripheral Quantitative Computed Tomography
Time frame: at 10 months.
bone mineral status measured by Quantitative Ultra-Sound (QUS) on the non-dominant calcaneus.
Time frame: at 10 months.
Endocrine assays
Time frame: at 10 months.
Adolescents' observance to the weight loss lifestyle program
Time frame: at 10 months
Metabolomics analysis in blood plasma
Time frame: at 10 months
Ex-vivo mechanistic analysis
Time frame: at 10 months
left ventricular end diastolic diameter measured by echocardiography
Time frame: at 10 months
left ventricular end systolic diameter measured by echocardiography
Time frame: at 10 months
posterior wall thickness measured by echocardiography
Time frame: at 10 months
interventricular septum thickness measured by echocardiography
Time frame: at 10 months
left ventricular mass indexed measured by echocardiography
Time frame: at 10 months
left ventricular ejection fraction measured by echocardiography
Time frame: at 10 months
valves velocity measured by echocardiography
Time frame: at 10 months
isovolumic relaxation time measured by echocardiography
Time frame: at 10 months
strain rate measured by echocardiography
Time frame: at 10 months
myocardial dyssynchrony measured by echocardiography
Time frame: at 10 months
carotid-intima-media thickness measured by echography
Time frame: at 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 27797988Chaplais E, Dutheil F, Naughton G, Greene D, Pereira B, Thivel D, Courteix D. Cross-sectional and longitudinal study protocols of the 'ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents' (ADIBOX) project. BMJ Open. 2016 Oct 18;6(10):e011407. doi: 10.1136/bmjopen-2016-011407.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight loss in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA) (time frame: at 10 months.). 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?
On the ClinicalTrials.gov record for NCT02626273, 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 29 Jul 2016.