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ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents (ADIBOX)

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ClinicalTrials.gov Identifier: NCT02626273
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : December 10, 2015
Last Update Posted : July 29, 2016
Sponsor:
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
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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 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.


Condition or disease Intervention/treatment Phase
Obesity Radiation: weight loss Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents
Study Start Date : September 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group
an intervention group who will undergo the management program combining physical activity and restrictive diet at Tza Nou Medical House for 10 months
Radiation: weight loss
a control group
a control group who will not undergo any intervention
Radiation: weight loss



Primary Outcome Measures :
  1. change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA) [ Time Frame: at 10 months. ]
  2. change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA) [ Time Frame: at 10 months ]

Secondary Outcome Measures :
  1. Whole body measured by Dual energy X-ray Absorptiometry (DXA) [ Time Frame: at 10 months ]
  2. weight waist [ Time Frame: at 10 months. ]
  3. waist circumference [ Time Frame: at 10 months. ]
  4. lower limb bone lengths [ Time Frame: at 10 months. ]
  5. Physical activity measured with International Physical Activity Questionnaire [ Time Frame: at 10 months. ]
  6. Tanner's stages model for pubertal maturation [ Time Frame: at 10 months. ]
  7. Energy metabolism assessed by cycle-ergometer submaximal aerobic fitness [ Time Frame: at 10 months. ]
  8. bone mineral density measured by Peripheral Quantitative Computed Tomography [ Time Frame: at 10 months. ]
  9. bone mineral status measured by Quantitative Ultra-Sound (QUS) on the non-dominant calcaneus. [ Time Frame: at 10 months. ]
  10. Endocrine assays [ Time Frame: at 10 months. ]
  11. Adolescents' observance to the weight loss lifestyle program [ Time Frame: at 10 months ]
  12. Metabolomics analysis in blood plasma [ Time Frame: at 10 months ]
  13. Ex-vivo mechanistic analysis [ Time Frame: at 10 months ]
  14. left ventricular end diastolic diameter measured by echocardiography [ Time Frame: at 10 months ]
  15. left ventricular end systolic diameter measured by echocardiography [ Time Frame: at 10 months ]
  16. posterior wall thickness measured by echocardiography [ Time Frame: at 10 months ]
  17. interventricular septum thickness measured by echocardiography [ Time Frame: at 10 months ]
  18. left ventricular mass indexed measured by echocardiography [ Time Frame: at 10 months ]
  19. left ventricular ejection fraction measured by echocardiography [ Time Frame: at 10 months ]
  20. valves velocity measured by echocardiography [ Time Frame: at 10 months ]
  21. isovolumic relaxation time measured by echocardiography [ Time Frame: at 10 months ]
  22. strain rate measured by echocardiography [ Time Frame: at 10 months ]
  23. myocardial dyssynchrony measured by echocardiography [ Time Frame: at 10 months ]
  24. carotid-intima-media thickness measured by echography [ Time Frame: at 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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. .

Exclusion Criteria:

  • pregnant girl
  • diabetes
  • insulin-resistance
  • hypo or hyper-thyroid
  • consuming alcohol
  • smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626273


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Frederic DUTHEIL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02626273     History of Changes
Other Study ID Numbers: CHU-0249
2015-A01024-45 ( Registry Identifier: 2015-A01024-45 )
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
obesity
adolescents
physical activity
adipocytes
osteocytes
weight loss
bone
fat

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms